Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023, <a href="https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf">a proposal</a> (Proposal) to amend the transitional regime under the <a href="https://eur-lex.europa.eu/eli/reg/2017/745/2020-04-24">Medical Device Regulations</a> (MDR) and certain related rules under the<a href="https://eur-lex.europa.eu/eli/reg/2017/746/2022-01-28"> In Vitro Diagnostic Medical Device Regulations</a> (IVDR). It is based on suggestions made by the Commission at the end of last year, which we have already discussed on our <a href="https://lifesciences.mofo.com/topics/eu-mdr-and-ivdr-implementation-signs-of-relaxing-transitioning-regime-and-bridging-measures#_ftnref4">MoFo Life Sciences blog</a>.The Commission proposes:<ul><li>an extension of the validity of certificates (MDR),</li><li>an extension of the transition period (MDR), and</li><li> the removal of the “sell-off” periods (MDR and IVDR).</li></ul>As becomes apparent from the above, the changes to the transition periods are limited to the MDR. The transitional regime of the IVDR was extended already at the beginning of 2022, so that the Commission deems the capacity challenges to no longer be so severe for in vitro diagnostics. We discussed the IVDR transitional periods in our previous blog post <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html">here</a>.BackgroundThere is a uniform understanding that an extension of the MDR/IVDR transitional regime is indispensable to combat a potential European health crisis and maintain patients’ access to a wide range of medical devices while ensuring the transition to the MDR framework. Our previous blog post discussed the lack of clarity in the <a href="https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf">Commission’s initial suggestions of December 2022</a> (Initial Suggestions). Among other things, the Initial Suggestions imprecisely specified the conditions to be fulfilled for a device to be covered by the proposed extended transitional periods. In terms of the extension of the validity of certificates, it was also unclear whether certain “legal and practical reasons” would serve as a criterion for such an extension and how the Commission would fill these terms with live. Moreover, it was unclear whether an extension would be granted retroactively to certificates already expired at the time of entering into force of the proposal.Details of the ProposalThe new Proposal brings more clarity for stakeholders.Extension of the transition period (Article 1(1), point (b) of the proposal)The Commission suggests to extend the transition period for higher-risk devices (class III and class IIb implantable devices, except certain devices for which the MDR provides exemptions) from May 26, 2024, until December 31, 2027, and for medium- and lower-risk devices (other class IIb devices and class IIa, Im, Is, and Ir devices) until December 31, 2028.The extended transitional periods only apply if the following conditions are met:<ul><li>devices continue to comply with <a href="https://eur-lex.europa.eu/eli/dir/1993/42/oj">Medical Devices Directive</a> (MDD) and <a href="https://eur-lex.europa.eu/eli/dir/1990/385/2007-10-11">Active Implantable Medical Devices Directive</a> (AMDD);</li><li>there are no significant changes in the design and intended purpose;</li><li>the devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health;</li><li>no later than May 26, 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9) MDR;</li><li>no later than May 26, 2024, the manufacturer, or its authorized representative, has lodged a formal application in accordance with Annex VII, Section 4.3 of the MDR for a conformity assessment in respect of a “legacy device” covered by a Directive’s certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3 of the MDR.</li></ul>The proposed amendment further introduces a transition period until May 26, 2026, for class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR.Extension of the validity of certificates (Article 1(1) point (a) of the proposal)The Commission further proposes to amend Article 120(2) MDR to extend the validity of certificates previously issued under the MDD that were valid on the day of the MDR’s date of application (May 26, 2021) and have not been withdrawn by a notified body. Certificates are intended to remain valid for the duration of the proposed extended transition period of the respective risk class applicable for the device set forth above.For certificates that have already expired at the time the amendments to the MDR, as suggested by the Proposal, take effect, the extension would be subject to the condition that, before the date of expiry of the MDD certificate, the manufacturer signed a written agreement with a notified body for the conformity assessment of the device in question. Or if no such agreement has been signed at the time of the expiry of the validity of the MDD certificate, a national competent authority has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 MDR or has required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 MDR.Removal of the “sell-off” deadline in the MDR and IVDR (Article 1(1), point (c) and Article 2(1) of the proposal)It is further proposed to remove the current “sell-off” date in Article 120(4) MDR (May 27, 2025) and in Article 110(4) IVDR (May 25, 2025 to May 26, 2028). In this case, devices placed on the market before the respective end of the transition period could be made further available on the market without a legal time restriction.Assessment of the proposed amendmentsAlbeit announced for the beginning of 2023, many stakeholders doubted that the Commission would issue the Proposal at this rapid pace. By doing so, the Commission clearly recognized the urgent risks of medical device shortages in the European Union as a result of MDR implementation challenges.Stakeholders in the industry have already signaled that they very much welcome the proposed extensions. From a legal perspective, the Proposal brings one thing above all: more clarity.In particular, the conditions to be met for a device to be covered by the proposed extended transitional periods have been clarified. Whereas the Commission’s Initial Suggestions vaguely stated that certain steps to initiate certification procedures under the MDR are required, it is now clear that the manufacturer must, among other things, have lodged a formal application for a conformity assessment and have signed a written agreement with such notified body. Of course, this does not mean that manufacturers can lean back and slow down their transition efforts. To the contrary, given the notorious capacity issues at notified bodies, it will be critical for them to move fast to secure a signed contract with a notified body in time.Moreover, it is a huge step that MDD certificates will be extended and that even MDD certificates already expired at the time of entering into force of the Proposal’s amendments will benefit from such an extension. Yet, these manufacturers will have to be able to demonstrate that the devices in question are in “transition” before expiry of the respective MDR certificate. This is not only a prerequisite under the Proposal, which requires a written contract with the notified body, but, according to the position paper of the Medical Device Coordination Group (MDCG) (MDCG 2022-18), also a criterion to obtain an extension by a competent authority pursuant to Article 97 MDR. Finally, the removal of the “sell-off” period in the MDR and IVDR is a major step toward reducing the risk of overstocking and preventing unnecessary disposal of safe medical devices and in vitro diagnostic medical devices.OutlookThe Proposal needs to be adopted by the European Parliament and the Council, and it might still undergo some changes in this process. While it is unclear when and if the proposed amendments will become effective, the previous corrigenda of the MDR have demonstrated that adoption can be swift, which in this case is necessary to ensure that patients and healthcare systems have continuous access to all categories of medical devices. At the moment, stakeholders should further pursue their transition strategy but should closely monitor these critical developments in the coming months. Watch this spot for more updates on this and other EU regulatory matters.MoFo research assistant Nicole Gebert has contributed to this article. ***

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Robert advises companies in the healthcare, pharmaceutical, medical device, and technology industries on all aspects of intellectual property law, primarily in connection with commercial life sciences, licensing, and technology transactions. His clients range from multinational companies to startups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime

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Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023,a proposal (Proposal) to amend the transitional regime under theMedical Device Regulations (MDR) and certain related rules under the In Vitro Diagnostic Medical Device Regulations (IVDR). It is based on suggestions made by the Commission at the end of last year, which we have already discussed on ourMoFo Life Sciences blog.

EU MDR and IVDR Implementation: European Commission Publishes Full Proposal for Amending Transitional Regime

Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the <a href="https://eur-lex.europa.eu/eli/reg/2017/745/2020-04-24">Medical Device Regulation</a><a href="#_ftn1" target="_self" id="_ftnref1">[1]</a> (MDR) and <a href="http://data.europa.eu/eli/reg/2017/746/2022-01-28">In Vitro Diagnostic Medical Device Regulation</a><a href="#_ftn2" target="_self" id="_ftnref2">[2]</a> (IVDR) :<ol><li>The EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) discussed the outline of an EU Commission (Commission) proposal for targeted amendments of the transition periods under the MDR and IVDR on December 9, 2022, which will be incorporated into a draft legislation by the beginning of 2023.</li><li>In a new position paper of the Medical Device Coordination Group (MDCG) (MDCG 2022-18), which was announced at the EPSCO meeting and published shortly thereafter, the MDCG discusses the use of bridging measures to provide a temporary solution to certificates that are expiring through application of Article 97 MDR.</li></ol>BackgroundDue to the grave shortage of notified body capacity and the sheer amount of medical devices and in-vitro medical devices (IVD), which need to be recertified under the new legislative framework, most manufacturers will not be able to attain MDR or IVDR certification before the end of the respective transition period, which for medical devices ends as early as May 2024.The scope of the problem is immense: there have been 8,120 applications from manufacturers and 1,990 certificates granted under the MDR so far. By contrast, 22,793 valid certificates issued under the <a href="https://eur-lex.europa.eu/eli/dir/1993/42/oj">Medical Devices Directive</a><a href="#_ftn3" target="_self" id="_ftnref3">[3]</a> (MDD) and <a href="https://eur-lex.europa.eu/eli/dir/1990/385/2007-10-11">Active Implantable Medical Devices Directive</a><a href="#_ftn4" target="_self" id="_ftnref4">[4]</a> (AMDD) are due to expire on May 26, 2024, at the latest. If the current rate of certificate issuance continues without change, the number of MDR certificates issued by May 2024 may reach around 7,000. Furthermore, the number of notified bodies remains a bottleneck—36 bodies have been designated under the MDR, but a further 26 applications are currently being processed.Commissions SuggestionsDuring the EPSCO meeting on December 9, 2022, health ministers from the EU member states joined forces to support the Commission’s proposal to extend the transitional provisions in Article 120 MDR, which were already outlined prior to the meeting in a Commission’s <a href="https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf">information note</a> of December 6, 2022. The Commission precipitated this development in response to urgent concerns expressed by several EU member states, members of the European Parliament, stakeholders, the MDCG and feedback from notified bodies.Among other things, the Commission suggests the following MDR amendments (despite the proposal claiming to extend both the MDR and IVDR, the suggested transition period extensions only cover the MDR):To extend the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Class III and class IIb devices (high risk) may extend to 2027 and class IIa and class I devices (medium risk) may extend to 2028 (low risk);If needed for legal and practical reasons, to extend the validity of MDD/AMDD certificates;Set conditions to be fulfilled in order to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety, have not undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. May 26, 2024); and To remove the ‘sell off’ provision in Article 120(4) MDR.The suggested extended transition periods for medical devices under the MDR would be staggered according to risk classes:<table><tbody><tr><td>Device class</td><td>Current transitional period</td><td>Proposed transition period</td></tr><tr><td>I</td><td>May 26, 2024</td><td>2028</td></tr><tr><td>IIa</td><td></td><td>2028</td></tr><tr><td>IIb</td><td></td><td>2027</td></tr><tr><td>III</td><td></td><td>2027</td></tr></tbody></table>The EPSCO unanimously supported extending the transition periods and opted for a swift adoption. The Commission’s proposal will be presented at the beginning of next year, but it’s unknown what it will entail and to which specific dates the transitional periods will be extended. While it is unclear when the changes will become effective, previous corrigenda have demonstrated that adoption can be swift. It will be worth monitoring further developments and details in the coming months.MDCG Position Paper on the Application of Article 97 MDR to Devices with Expired or Expiring CertificatesThe Commission also saw a need for bridging measures before this legislative change can be implemented, which led to the MDCG position paper (MDCG 2022-18) that seeks to ensure the application of Article 97 MDR to legacy devices under the MDD or AMDD. This is in line with prior position papersMDCG 2022-11 and MDCG 2022-14, which had already indicated the use of Article 97 MDR measures.The original purpose of Article 97 MDR was to allow EU member states to issue exemptions for medical devices that do not comply with the requirements of the MDR, but do not pose an unacceptable risk to patients or other individuals. In this case, the competent authorities (usually the national regulatory agency responsible for medical devices) can require the manufacturer or other relevant economic operators to correct the non-compliance within a reasonable amount of time.The MDCG 2002-18 recommends, with a coordinated set of criteria, that EU member states may apply this mechanism to devices that are ‘in transition’ from the MDD or AMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.The major advance of this position paper is that EU member states should recognize Article 97(1) MDR decisions issued by other EU member states, requiring only one application to cover the entire European Union.Manufacturers whose certificates have expired or will expire before receiving their notified body certificate under the MDR are advised to proactively inform the competent authority of the EU member state in which they or their authorized representative have their registered place of business about the forthcoming or incurred non-compliance with the relevant MDR requirements. An evaluation of the risk posed by the device, as well as any other non-compliance requirements, is then required by the competent authority. As long as the competent authority determines that there is no unacceptable risk to health and safety, Article 97(1) MDR will apply.Non-compliance must be resolved within a reasonable and clearly defined timeframe, and the manufacturer should already have undertaken reasonable efforts to transition its device to the MDR. That means, in particular, that the manufacturer’s application for conformity assessment under the MDR should have been accepted by a notified body and a written agreement signed by the notified body and manufacturer in line with section 4.3 of Annex VII MDR.ConclusionBoth developments are to be welcomed, as they have the potential to take an enormous amount of pressure off the market. However, the Commission’s proposal is not final, and there remains a lack of clarity as to the details of the proposed extensions.For example, according to the Commission’s proposal, an extension may only be granted for devices whose manufacturers have already taken steps to initiate certification procedures under the MDR, the uncertainty about what this means poses a problem. Yet it is unclear under which conditions this is the case. Does this require that the manufacturer must only adapt his quality management system, or would the notified body have to have accepted the manufacturer's application for conformity assessment?Moreover, in terms of extensions of MDD certificates, it is unclear when, according to the Commission’s proposal, such an extension is needed for “legal and practical reasons” and whether such an extension would be granted retroactively to already expired certificates.The most significant challenges with respect to the MDCG position paper seem to be that it is unclear how it relates to a proposed extension of the validity period for certificates under Article 120(2) beyond May 26, 2024, and that it remains to be seen how competent authorities will manage the influx of applications for Article 97 MDR exemptions. It is quite conceivable that the competent authorities for Article 97 MDR exemptions turn out to be a bottleneck, just as notified bodies do for MDR certification.Watch this spot for further information on the latest developments in MDR and IVDR implementation.MoFo Research Assistant Nicole Gebert contributed to this article.<hr class="divider"><a href="#_ftnref1" target="_self" id="_ftn1">[1]</a> Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017<a href="#_ftnref2" target="_self" id="_ftn2">[2]</a> Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017<a href="#_ftnref3" target="_self" id="_ftn3">[3]</a> Council Directive 93/42/EEC of 14 June 1993<a href="#_ftnref4" target="_self" id="_ftn4">[4]</a> Council Directive 90/385/EEC of 20 June 1990

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EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

Concerns over possible medical device shortages in the EU have led to two recent developments that will affect the implementation of the Medical Device Regulation(MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR)

EU MDR and IVDR Implementation: Signs of Relaxing Transitioning Regime and Bridging Measures

In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging practices of parallel importers. The court held that, based on European Union trademark law, the drug manufacturers can stop parallel importers from distributing their medicinal products if they have been repackaged in new outer packaging with the corresponding trademark of their medicinal product affixed.The practice of parallel importers in the medical sectorDue to differing price levels on the pharmaceutical markets in various EU member states, parallel importers buy drugs for a lower price in one market (e.g., Eastern Europe) and sell them at higher prices in other markets (e.g., Germany). The products are either relabeled or the outer packaging is replaced in its entirety in order to change the packaging language. In the latter case, the trademark of the reference product is affixed to such repackaging by the parallel importer. In the current cases, pharmaceutical companies Bayer and Novartis have opposed this repackaging practice of parallel importers kohlpharma and Abacus.Legal framework shaped by CJEU case lawThe CJEU has dealt with parallel imports of medicinal products in several landmark decisions. The starting point is the right of the drug manufacturer to prohibit third parties from using its trademark during trade (Art. 9 para. 2 of the EU trademark regulation 2017/1001). However, due to the principle of free movement of goods within the EU and the fact that the trademark proprietor’s rights are generally exhausted for the entire EU once an individual product bearing the mark has been placed on the EU market (Art. 15 of the EU trademark regulation 2017/1001), it is settled case law that parallel imports of medicinal products are generally permissible (case no. C-16/74). For repackaged products, this is only the case if the conditions carved out by the CJEU in previous decisions (joined case nos. C-427/93, C-429/93, and C-436/93) are fulfilled. The conditions require that (i) repackaging is necessary for commercializing the goods in the import market, (ii) the condition of the goods is not affected, (iii) the repackaging is made transparent on the goods, (iv) the importer informs the manufacturer about the repackaging, and (v) the new presentation does not cause damage to the reputation of the trademark.Repackaging v. relabeling of pharmaceutical productsIn the decisions at hand, the CJEU focuses more closely on the necessity of repackaging over pure relabeling. The court recognizes that repackaging has a stronger impact on the rights of the trademark proprietor than mere relabeling. The court emphasizes that the repackaging must therefore be a necessary means for the importing of the product. This, according to the court, would be the case, if regulations or practices in the importing EU member state prevent the distribution of that product on the market of that EU member state in the same packaging in which the product is distributed in the exporting EU member state. However, it would not be the case if the repackaging of the product is based exclusively on the parallel importer’s desire to obtain an economic advantage.The parallel importers argue that repackaging is necessary due to the requirements of the <a href="https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines-overview#:~:text=The%20European%20Union%20%28EU%29%20has%20a%20strong%20legal,for%20sale%2C%20including%20legitimate%20sale%20via%20the%20internet." target="_blank">EU falsified medicines laws</a>, which provide that all medicinal products sold in the EU must have a unique identifier (i.e., a barcode) and an anti-tampering device (i.e., a security seal to verify whether the packaging of a medicinal product has been opened or altered) to ensure that their content is authentic (see Art. 47a of Directive 2001/81, inserted by Directive 2011/62/EU and Art. 4 Regulation 2016/161). In order to replace the package leaflet of the original product with a package leaflet in the language of the import market, the anti-tampering device will have to be broken. If the packaging would only be relabeled and a new anti-tampering device added, the traces of the damaged original security seal may still remain visible. Parallel importers claim that this would be a major barrier to importing the products into other EU member states as medicinal products with damaged packaging are less likely to be accepted, especially by consumers.In the decisions at hand, the CJEU considered these risks to be less significant. It held that the aforementioned Article 47a(1)(b) of Directive 2001/81 allows reuse only on the condition that the original security features can be replaced by those that are equally suitable for verifying the authenticity and identity of the medicinal products concerned and for providing evidence of their tampering. The fact that wholesalers or consumers may be irritated by traces of a broken anti-tampering device has no bearing, as it only had to be made clear to them that these traces were made by the parallel importer. A general presumption of consumer resistance to relabeled drugs is not sufficient to require repackaging. This may only be different if it was clearly demonstrated that a significant proportion of consumers decided against purchasing the relabeled products. Under these circumstances, the repackaging of the products in new packaging would not be aimed exclusively at an economic advantage, but at gaining effective access to the market.ConclusionThe two CJEU decisions are good news for manufacturers, as they raise the bar for repackaging of parallel imported drugs. Importers will now have to provide proof for each market that the majority of consumers are less likely to buy relabeled products over repackaged products, even when they are informed that relabeling was done by the parallel importer. Otherwise, only relabeling will be permissible.MoFo research assistant Tim Stripling contributed to this article.

Relabeling vs. Repackaging: CJEU Backs Drug Manufacturers’ Position Against Parallel Importers

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In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging practices of parallel importers. 

After a myriad of <a href="https://www.mofo.com/resources/insights/200334-europes-unified-patent-court.html?utm_source=publication&utm_medium=email" target="_blank">challenges</a>, <a href="https://www.linkedin.com/pulse/unified-patent-courtunexpected-roadblocks-ahead-germany-sch%C3%B6nig/" target="_blank">delays</a>, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an international organization. This date marks the beginning of the Provisional Application Period (PAP), which was triggered by the thirteenth member state’s ratification of the PAP Protocol. The Administrative Committee, one of three governing bodies of the UPC, had no time to lose and took up its preparatory work with an <a href="https://www.unified-patent-court.org/news/announcement-unified-patent-court-administrative-committees-inaugural-meeting" target="_blank">inaugural meeting</a> on February 22, 2022.  Since then, preparatory measures seem to be in full swing. The interview process for candidate judges began at the end of March 2022. As soon as the Court will be deemed functional, which is expected to take about eight months of preparations, Germany will deposit its ratification of the Unified Patent Court Agreement (UPCA), a final step which it is – in agreement with the other member states – currently holding back in order to control the timeline.  From that moment, the final countdown of three months will be initiated until the UPCA will enter into force and the UPC will open its doors.With the UPC having reached the home stretch, Supplementary Protection Certificates (SPCs) have come into the limelight as the fundamental area of intellectual property (IP) protection that remains fragmented among the member states.SPCs are sui generis IP rights. They grant up to five years (and in cases of pediatric extensions, five and one half years) of additional protection for a medicinal or veterinary product or a plant protection product that has gained market authorization. SPCs were introduced to offset the lengthy process of regulatory proceedings. Protection is based on EU regulation No. 1610/96 (concerning SPCs for plant protection products) and No. 469/2009 (concerning SPCs for medicinal products) (“SPC Regulations”) and is available in all EU member states. However, application and approval is handled on the member state level.  This remained the same despite the advent of the European Patent Package, which introduced the Unitary Patent (UP) and the UPC, but did not provide for unitary SPCs.[The European Patent Package introduced the Unitary Patent (UP), a single patent having effect in all participating EU member states, and the Unified Patent Court (UPC), a court system having jurisdiction over UPs with its decisions having effect in all participating member states.]As a consequence, UPs can only be extended by national SPCs.During an evaluation in 2020, the <a href="https://ec.europa.eu/docsroom/documents/43847" target="_blank">European Commission (EC) found</a> that the SPC system in general provides effective incentives for innovations, and the EC ascertained that the main shortcomings are rooted in the national administration and management of SPCs. Therefore, the EU Parliament called on the EC to address this SPC fragmentation. In the course of its legislative work, the EC has launched a so-called “Call for Evidence” to gather feedback on how to tackle that issue. The Call for Evidence brings up three topics for discussion:a) The baseline scenario with no policy change. The SPC system would continue to operate on the basis of existing EU and national rules. Member states might continue in an uncoordinated manner to recalibrate their SPC practices, with different approaches persisting across the single market.b) Non-legislative instruments, including guidelines based on the best practices of national patent offices and the case law of the Court of Justice of the European Union (CJEU), aimed at further harmonizing the current SPC system.c) Legislative changes, which would possibly be combined with non-legislative changes, including:1) Creation of a centralized system for SPC protection in the EU, with a view to reducing the cost and burden and making the procedure for granting SPCs more predictable. A centralized system would facilitate the setting up of standardized, common, and publicly available digital databases. This centralized system could consist of: (i) a unitary SPC, complementing the future unitary patent; (ii) a unified procedure for granting bundles of national SPCs, without creating a unitary SPC; or (iii) a combination of the two. The detailed features of a centralized SPC system will be assessed in an impact assessment (e.g., an examining and granting authority (a virtual authority comprising SPC experts from Member States, or an EU authority), language arrangements (English-only or multilingual), and judicial review); and2) Targeted amendments of the SPC Regulations on the basis of the best practices of national patent offices and CJEU case law aimed at further harmonizing the current SPC system.The Call for Evidence is open for feedback until April 5, 2022. Any members of the public may provide their feedback and comments. Submissions will be published <a href="https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13353-Medicinal-&-plant-protection-products-single-procedure-for-the-granting-of-SPCs_en">here</a>.Meanwhile, the UPC committees will continue their preparatory work. A fully operational UPC is expected to open its doors in early 2023, if not in late 2022. From that moment, a seven-year transitional period, during which patent holders may opt out of the exclusive jurisdiction of the UPC, will kick off. It is crucial for holders and applicants of UPs to make well-balanced decisions and keep an eye on the UPC strategies of other market participants.On the one hand, the exclusive jurisdiction of the UPC comes with the advantage of a cost-effective litigation system. To participate in the UPC could be seen as an opportunity to shape this new system. On the other hand, being at the mercy of a newly set up court might be daunting, as outcomes could be perceived as less predictable than in the more familiar systems. This might particularly be the case in light of the fact that a declaration of invalidity would stretch to all participating member states.Therefore, the right strategy can only be tailored in view of the risks or strengths attached to specific patent portfolio and its market environment. Owners and applicants should use the home stretch of the UPC to become familiar with the UPC system and its procedures and get advice on UPC strategy, where needed.

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A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum

Healthcare, Biologics, and Severability: Will the ACA—and the BPCIA—Survive the Latest Challenge?

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After a myriad of challenges, delays, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction.

A Long Courtship for Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About a Unitary Supplementary Protection Certificate Gain Momentum

<div><h4>Summary</h4></div><ul><li>The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in awe.</li><li>A study recently published by the European Commission (“Commission”) now calls for targeted policy action regarding plants derived from targeted cis- and mutagenesis, with an inception impact assessment expected in the third quarter of 2021, as the study revealed that: <ul><li>The current European legislation regarding genetically modified organisms (GMOs) is no longer fit for its purpose with respect to plants derived from targeted cis- and mutagenesis.</li><li>Scientific review did not uncover any new hazards linked to targeted cis- and mutagenesis compared to conventional breeding methods or random mutagenesis.</li><li>In particular, in the agri-food sector, use of NGTs is likely to result in plants more resilient to diseases and climate change effects that have the potential to contribute to a more sustainable agri-food system and thus benefit society.</li><li>Only 21% of EU consumers have ever heard of “gene-editing” but general perception of such technologies is still negative.</li><li>Disparities between public perception and limited public knowledge about NGTs could hamper NGTs market uptake. </li><li>Different regulatory oversight for NGTs in other countries could lead to trade limitations and disruptions, and put EU operators at a competitive disadvantage.</li></ul></li><li>A basic problem identified by the study is the lack of reliable methods to detect such NGT products. To ensure a level playing field for all stakeholders involved, such methods must be able to distinguish between regulated and unregulated products, which is, however, a challenge from a scientific point of view. Alternatively, the study suggests a document-based traceability system, which would, however, involve additional costs and could affect the international competitiveness of EU operators.</li><li>The study suggests that a more flexible approach to assessment of risk of NGTs should be undertaken on a case-by-case basis, rather than the restrictive regulatory framework that is currently in place.</li></ul>With respect to other organisms than plants (microorganisms and animals) and other NGTs than cis- and mutagenesis (e.g., epigenetic editing), however, the study observes substantial knowledge gaps. While the Commission intends to build further knowledge, at this stage other organisms and other NGTs will remain subject to the current GMO legal framework.<a target="_blank" href="https://www.mofo.com/resources/insights/210525-novel-genomic-techniques.html?utm_source=publication&utm_medium=email">Read our alert</a>

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The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

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Summary


The decision of the Court of      Justice of the European Union (CJEU) in case C-528/16 essentially banning      novel genomic techniques (NGTs), in 

The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts.[1] In two recent rulings – “Lundbeck”[2] and “Paroxetine”[3] – the European Court of Justice (ECJ) dealt with settlement agreements between originator companies and generic companies aimed at delaying the introduction of generic drugs to the market, so-called “pay-for-delay” or “reverse patent settlement” agreements. In these agreements, the generic companies usually commit to refrain from entering the market for a relevant medicine protected by a (possibly contestable) patent that the originator company holds while the originator company is obliged to pay a certain compensation. The recent ECJ judgments indicate that most of the “pay-for-delay” agreements likely constitute anti-competitive agreements by object and hence violate EU antitrust laws.<h4>Facts/Background</h4>The ECJ provided fundamental guidance regarding questions on “pay-for-delay” agreements in its preliminary ruling in “Paroxetine” on January 30, 2020. In this case, the British Competition Appeal Tribunal (“CAT”) referred various questions to the ECJ for a preliminary ruling. The background for the legal proceedings were settlement agreements with respect to patent disputes between GlaxoSmithKline (the holder of a patent for the paroxetine anti-depressant) and certain generics companies, in which the generics companies agreed to refrain from entering the market with their own generic medicines for a certain period of time and GlaxoSmithKline promised payments in return.In its “Lundbeck” decisions of March 25, 2021, the ECJ applied the principles established in “Paroxetine” to a fine decision of the EC. The ECJ confirmed the previous EC decision including the ruling of the General Court to fine Lundbeck (originator company of the citalopram anti-depressant) and producers of generic medicines for their anti-competitive settlement agreements. After the original compound patent expired in 2002, Lundbeck (still holding a number of secondary patents) and several generic companies entered into “pay-for-delay” agreements. The generic companies committed not to enter the citalopram market and Lundbeck made in return significant payments and also purchased their stocks of generic products. Those agreements led to investigations concluded by the EC’s decision of June 19, 2013[4] to fine Lundbeck and the generic companies. Their appeals before the General Court were dismissed by various judgments of September 8, 2016. Finally, the ECJ dismissed the appeals against the Court’s decisions.<h4>The ECJ Decisions</h4>The ECJ’s decisions mainly focus on the standards of the European cartel ban (Article 101 TFEU) and the rules on abuse of dominance (Article 102 TFEU, see particularly “Paroxetine”) applying to “pay-for-delay” agreements. They particularly provide clarity in which cases generic manufacturers could be considered as potential competitors and in which cases “pay-for-delay” agreements constitute a restriction of competition “by object” (or effect). While the preliminary ruling in “Paroxetine” provides the guidelines to assess “pay-for-delay” agreements in general, the ECJ confirmed and applied those guidelines to a specific fine decision in “Lundbeck.”Potential CompetitorsThe “pay-for-delay” agreements are only anti-competitive if the companies involved are at least “potential competitors.” According to the ECJ in its “Paroxetine” ruling, the relevant potential competition between the originator companies and the generic companies needs to be assessed with “regard to the structure of the market and the economic and legal context within which it operates.” To establish potential competition, the ECJ emphasized that there is no need for certainty that the generic company will in fact enter the market, but the generic companies must have “real and concrete possibilities of entering the market at the relevant time.” More precisely, according to the ECJ, this means that a potential competitor must have taken sufficient preparatory steps to enter the market at the time of the conclusion of the “pay-for-delay” agreement and must show a firm intention as well as an inherent ability to enter the market. Moreover, there shall be no “insurmountable barriers” for entering the market, but the ECJ clarified that the existence of a patent alone cannot be regarded as such an “insurmountable barrier” as long as the potential competitor shows a readiness to challenge the validity of that patent. According to the ECJ, it is not required to assess the “strength of the patent” or how likely it is that a court would find that the patent is valid and has been infringed. Restriction of Competition by ObjectRegarding the question when there is a “restriction of competition by object,” the ECJ pointed out that the agreements must reveal a sufficient degree of harm to competition, considering the agreement’s content, objectives, and economic and legal context. According to the ECJ, such a harm to competition is strongly indicated when the agreed transfers of value cannot have any explanation other than the commercial interest of the parties not to engage in competition on the merits. For this purpose, it is crucial to assess whether the net gain arising from the payments in question is high enough to act as an incentive to the generic companies to refrain from entering the market. However, the net gain is not required to be higher than the profits the generic company would have made if it were successful in the patent proceedings. As with the assessment of a “potential competition,” it is not necessary to assess the strength of the respective patents or of the party’s prospects of success in a patent process, if the transfer of value is significant enough.Abuse of DominanceIn its “Paroxetine” decisions, the ECJ also specified the conditions under which a “pay-for-delay” agreement constitutes an abuse of a dominant market position (Article 102 TFEU). According to the ECJ, the definition of the relevant product market must take the generic versions of the medicine into account, although the generic companies would not be able to legally enter the market. The ECJ further clarified that the exercise of an IP right, including the conclusion of patent settlement agreements, is not per se abusive, but that negative effects for competition arise if this exercise prevents access to the market. Finally, the ECJ pointed out that adverse effects on the market might be counterbalanced by efficiency advantages that also benefit consumers.<h4>Conclusion and Outlook</h4>After the EC and the General Court established the first principles for the assessment of “pay-for-delay” agreements in the pharmaceutical sector under EU antitrust law, the two ECJ rulings provided now more clarity and final guidance on this topic for various issues. This particularly concerns the qualification of the companies involved as “potential competitors,” the relevant test for assessing whether there is a “restriction of competition by object,” and the (non‑)relevance of the likelihood of success in patent proceedings. There are still some open questions, particularly regarding the defense of the companies involved with respect to potential pro-competitive effects or efficiencies. But this could also have been deliberately left open as, in general, the ECJ seems to put “pay-for-delay” agreements under close scrutiny. And while it does not generally prohibit those agreements, they are subject to a critical assessment resulting in “tough (antitrust) times” for any “pay-for-delay” agreements. [1] See prior client alert.[2] Judgments of the ECJ of March 25, 2021 in Cases C-586/16 P, C-588/16 P, C-591/16 P, C-601/16 P, C-611/16 P, and C-614/16 P.[3] Judgment of the ECJ of January 30, 2020 in Case 307/18.[4] EC Decision of June 19, 2013, Case AT.39226 – Lundbeck. in Cases T-460/13, T-467/13,, T-469/13, T-470/13, T-471/13, and T-472/13.

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Jens is a counsel at Morrison Foerster’s German office in Berlin. He advises clients in all areas of European and German competition law, including merger control filings, cartel authority investiga

Jens Hackl

Jens Hackl is a counsel at Morrison Foerster’s German office in Berlin. He advises clients in all areas of European and German competition law, including merger control filings, cartel authority investigations, cartel damage claims, distribution cartel law, antitrust compliance programs and unfair competition law. Jens has particular industry-specific experience in the areas of media, technology, telecommunication, transport and aviation. In addition, he advises in the fields of state aid and public procurement law.

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Managing Partner, Berlin

Andreas is managing partner of Morrison & Foerster’s German office in Berlin and a member of the firm’s worldwide board of directors. He heads the German antitrust and regulatory practice from our Ber

Andreas Grünwald

Andreas Grünwald is a partner in the Global Antitrust Law Practice Group, and head of Morrison & Foerster’s German antitrust practice. He covers a wide range of antitrust and regulatory matters, with a particular focus on the telecommunications, media and technology (TMT) sector. Based in our Berlin and Brussels offices, Mr. Grünwald provides antitrust advice on M&A strategy, represents public and private corporations in merger control proceedings before the German Federal Cartel Office and the European Commission, and he has notable experience in coordinating multi-jurisdictional merger filings involving European, U.S., and Asian authorities. He also advises on other transactional matters such as sector-specific permit requirements as they often arise in regulated industries.

Pay-for-Delay has a tough (antitrust) time at EU Top Court

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the Eu

Pay-for-Delay has a tough (antitrust) time at EU Top Court

In Part 6 of our <a href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html?utm_source=linkedin_elevate&utm_medium=social" target="_blank">series of consecutive articles</a> on the reformed regulatory framework under the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424" target="_blank">EU Medical Device Regulation 2017/745</a> (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the transition periods certain MDSW can benefit from before being required to fully comply with the MDR.Transitional periods are provided in Article 120 MDR. In part due to the COVID-19 pandemic, the original text of Article 120 MDR has been corrected by two corrigenda (<a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32017R0746R%2802%29">I</a>, <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32017R0746R%2803%29">II</a>) and another <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG">Regulation</a> to avoid additional burdens to stakeholders and impasses in the supply of medical devices. The changes introduced by these amendments are twofold: On the one hand, the scope of the existing transitional periods was substantially changed and now includes more devices. On the other hand, the MDR now reflects the pushed-back applicability dates of the MDR and their influence on the transitional periods.Due to the many amendments, however, the European legislator missed its aim to lay down clear and legible transitional rules. Therefore, the following article will decipher Article 120 MDR and provide an overview, which rules have to be observed when, as well as the prerequisites MDSW has to meet in order to benefit from the grace periods.<h4>1. INTRODUCTION: THE TERMINOLOGY OF ARTICLE 120 MDR</h4>The various transitional periods granted by Article 120 MDR allow for extended “placing on the market,” “making available on the market,” and “putting into service” of certain legacy MDSW, i.e., MDSW that was in compliance with the provisions of the current <a href="https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF" target="_blank">EU Medical Device Directive 93/42/EEC</a> (as amended by Directive 2007/47/EC – “MDD”). Other than with physical medical devices, it can be challenging to determine when these actions take place. It is thus worthwhile to take a closer look at their definitions under the MDR.Placing on the market means the first making available of a device, other than an investigational device, on the EU market (Article 2 (28) MDR). It is subject to an ongoing debate whether MDSW is placed on the market as soon as it is offered for download through a website or an App Store or whether every license or access key to a MDSW granted to a user is placed on the market upon issuance. The latter option seems favorable due to the underlying rationale of the MDR. Most of the MDR provisions, including the transitional rules, were designed with physical medical devices in mind, and it is therefore common understanding that the placing on the market applies separately to each individual device. Translated to MDSW, this means that every license or access key will only be considered placed on the market once it is issued to the user.Making available on the market means any supply of a device, other than an investigational device, for distribution, consumption, or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge (Article 2 (27) MDR). Putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the EU market for the first time for its intended purpose (Article 2 (29) MDR). Following the placing on the market through issuance of a license or access key to MDSW, it is then made available through the download by a user and put into service through its installation. These modalities therefore cover the maintenance of licenses to MDSW that were already granted to the user.It must be mentioned that while some notified bodies back these conclusions, they are not set in stone, as courts have not yet decided on these issues.<h4>2. TRANSITIONAL PERIODS FOR UP-CLASSIFIED MDSW</h4>In <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html">Part 3</a> of this series, we discussed that it is to be expected that many MDSW that are currently classified in Class I under the MDD will be up-classified to Class IIa or higher under the MDR regime (“Up-classified MDSW”). Such MDSW will benefit from the transitional periods of the MDR in two ways. First, new licenses and access keys to Up-classified MDSW may be granted until May 26, 2024 (Article 120 (3) MDR). Second, licenses and access keys granted until May 26, 2024, may be maintained until May 26, 2025 (Article 120 (4) MDR), i.e., users may use, download, and install Up-classified MDSW that they already purchased.a. Requirements for granting new licenses to Up-classified MDSWFor the aforementioned transitional periods to apply, the following requirements have to be met (see <a target="_blank" href="https://ec.europa.eu/docsroom/documents/40324/attachments/1/translations/en/renditions/native">MDCG 2020-2</a> Guidance for further instructions; please note that the dates mentioned therein do not reflect the dates of the current version of the MDR):<ul><li>The MDSW needs to continue to comply with the MDD.</li></ul><ul><li>A valid Declaration of Conformity (“DoC”) complying with Annex VII of the MDD must be drawn before May 26, 2021. With the DoC, the manufacturer of the MDSW declares that it meets the relevant requirements of the MDD. Comprehensive instructions on the form, content, and handling of the DoC can be found in the MDCG 2020-2 Guidance, the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:52016XC0726(02)">Blue Guide on the implementation of EU products rules 2016 (2016/C272/01)</a>, the standard EN ISO/IEC 17050-1/2, and the model declaration in Annex III of <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008D0768">Decision No 768/2008/EC</a>.</li></ul><ul><li>The MDSW must not undergo significant changes to its design or intended purpose after May 26, 2021. It cannot be emphasized enough that this provision can have far‑reaching implications for the manufacturer’s ability to benefit from the transitional period, as it covers a lot of changes that could be considered desirable or, in the worst case, even mandatory changes. While the MDR does not define when a change is ‘significant,’ some meaningful guidance can be drawn from the <a target="_blank" href="https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native">MDCG 2020-3 Guidance on Significant Changes</a> that leads the determination process through a series of flow charts. Additionally, the <a target="_blank" href="https://www.johner-institut.de/blog/wp-content/uploads/2015/11/Recommendation-NB-MED-2_5-2_Rec2_Reporting_of_design_changes_and_changes_of_the_quality.pdf">NB-MED Coordination on Council Directives 90/385/EEC, 93/42/EEC, and 98/79/EC</a> as well as the <a target="_blank" href="http://www.doks.nbog.eu/Doks/NBOG_BPG_2014_3.pdf">NBOG’s Best Practice Guide</a> should be considered. Following these guidelines, bug-fixes, security patches, and minor changes to non-critical parts of the user interface, such as spelling mistakes, will likely not be seen as significant. Vice-versa, changes to the intended user groups or changed indications, corrections of errors to minimize risks, changes to the user interface (like changing warning messages), or the use of a different runtime environment will likely be deemed significant (these examples are only for illustrative purposes and are not comprehensive).</li></ul>Any manufacturers of MDSW going this route are well advised to make themselves familiar with the guidance documents on significant changes. They should be aware that as MDSW by their very nature undergo a high volume of changes during their life cycle, it is likely that some of these changes could ultimately jeopardize the applicability of the transitional period.This risk is accelerated by the new <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32019L0770">EU Directive on Digital Content and Services 2019/770</a>, which contains a mandatory obligation to update digital products in order to keep them in conformity with the underlying contract (Article 8 (2)). These obligations also apply to products, for which the consumer “pays” for with personal data (Article 3 (1)). Depending on the nature of the MDSW and the respective contract, changes required in this context can be of a kind that would be seen as significant under the MDR. As the Member States of the EU have to transpose these rules into national laws until July 1, 2021, these obligations will be applicable to manufacturers of MDSW very soon.b. Maintaining existing licenses until May 26, 2025 (Article 120 (4) MDR)Designed as a sell-off provision for physical medical devices, Article 120 (4) MDR allows for the continued making available on the market and putting into service until May 26, 2025, of legacy medical devices that were placed on the market prior to May 26, 2024. For MDSW, this means that licenses and access keys that were already issued before May 26, 2024, can be maintained for another year. In this timeframe, the manufacturer can give users who have already obtained a license or access key further access to the MDSW, allow the respective installations, and use and offer technical support.<h4>3. TRANSITIONAL PERIODS FOR SAME-CLASS MDSW</h4>Legacy MDSW that is classified as Class I under the MDD and which will remain in Class I under the MDR regime (“Same-class MDSW”) will have limited transitional options. Only licenses or access keys to Same-class MDSW granted before May 26, 2021, may be maintained until May 26, 2025 (Article 120 (4) MDR), i.e., users may use, download, and install already obtained Same-class MDSW. This makes sense, as the main purpose for transitional periods must be found in the legislatures aim to avoid congestion of the bottleneck of certification, the notified bodies, and full compliance of Same-class MDSW with the MDR can be achieved by way of the continued possibility of self-certification of Class I devices, as we have shown in <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">Part 2</a> of this series.To be on the safe side, manufacturers of Same-class MDSW should also consider not changing their product as long as use of already-issued licenses and access keys are required before full compliance with the MDR.<h4>4. TRANSITIONAL PERIODS FOR HIGHER-CLASS MDSW</h4>Even though most MDSW under the MDD was classified in Class I, some software for high-risk medical scenarios was already in Classes IIa to III (“Higher-class MDSW”). For example, MDSW intended to image in vivo distribution of radiopharmaceuticals was in Class IIa and MDSW controlling emitters of ionizing radiation for therapeutic interventional radiology was in Class IIb (<a target="_blank" href="https://ec.europa.eu/docsroom/documents/17921/attachments/1/translations/en/renditions/native">MEDDEV 2.1/6 Guidance of July 2016</a>, p. 16).As Higher-class MDSW had to be certified by a notified body already under the MDD, the question whether new licenses and access keys may be granted depends on the continued validity of the certificate. Certificates to Higher-class MDSW certified prior to May 25, 2017, remain valid until the date indicated on the certificate.[1] Certificates to Higher-class MDSW certified after May 25, 2017, also remain valid until the indicated date but no longer than five years or until May 27, 2024, whichever is earlier. Accordingly, new licenses and access keys can be granted to customers as long as the MDSW certificate is valid but no longer than May 26, 2024 (Article 120 (2), (3) MDR).As with Up-classified MDSW, the following requirements have to be met for the transitional periods to apply.<ul><li>The MDSW needs to continue to comply with the MDD.</li></ul><ul><li>The MDSW must not undergo significant changes to its design or intended purpose after May 26, 2021.</li></ul>Any licenses and access keys granted in the described timeframe may be maintained until May 26, 2025 (Article 120 (4) MDR).<h4>5. MDR REQUIREMENTS TO BE MET DURING THE TRANSITIONAL PERIOD</h4>The transitional period must not be understood as a delay of application of the MDR. The following MDR provisions have to be complied with from May 26, 2021, in any scenario (Article 120 (3) MDR):<ul><li>Post-market surveillance (Article 83 et seq, “PMS”): as we have shown in <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html">part 4 of this series</a>, manufacturers of MDSW need to establish a PMS system that systematically gathers records and analyzes relevant data on the quality performance of MDSW for its entire lifetime. As a result, the manufacturer needs to draw the necessary conclusions from the findings and implement preventive and corrective actions. Additionally, manufacturers of MDSW in Classes IIa to III have to prepare a Periodic Safety Update Report summarizing the results and conclusions out of the abovementioned aspects.</li></ul><ul><li>Vigilance (Article 87 et seq): Manufacturers of MDSW are required to investigate and report serious incidents and take and report field safety corrective actions with regard to their products. Furthermore, they have to report on trends concerning the frequency or severity of side effects that are documented in the MDSW informational material and the technical documentation. For further information on incident reporting, please refer to <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html">part 4 of this series</a>.</li></ul><ul><li>Registration of economic operators and of devices (Article 29 et seq): manufacturers will have to register their MDSW in accordance with the Unique Device Identifier (“UDI”) system that we have covered extensively in <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe--New-Regulatory-Regime-About-To-Enter-Into-Force--Part-5-of-6.html">Part 5 of our series</a>. In addition, they need to register themselves with a unique Single Registration Number (“SRN”) and, where applicable, the authorized representative and the importer. SRNs are assigned by the competent authorities in the EU member states. The registration will be carried out through the European Databank on Medical Devices (“EUDAMED”), which is in the process of being set up.</li></ul><ul><li>Market surveillance (Article 93): the provisions on market surveillance cover the duties and activities carried out by the competent authorities to ensure that medical devices do not pose significant risks to the health and safety of patients. It therefore does not directly apply to manufacturers of MDSW.</li></ul><h4>6. CONCLUDING REMARKS</h4>As it is to be expected that many Class I MDSW will be up-classified under the MDR, developers should be duly prepared to qualify for the transitional periods and put the delay to good use. First, they should assess any upcoming necessary changes to their products and plan on pushing back any of them that could be deemed significant, as they could lead to abrupt applicability of all relevant MDR requirements (although there may be cases where they are forced to implement changes under PMS). Second, manufacturers should familiarize themselves with their obligations regarding PMS, vigilance, and registration and be ready for full compliance from May 21, 2021. Third, they should start preparing for MDR certification as additional pressure on the Competent Authorities at the end of the transitional periods are predictable. Manufacturers should begin to, inter alia, collect clinical data on their MDSW, set up a Quality Management System, and draft Clinical Evaluation plans.Timely preparation is of the essence as only an on-time certification can ensure a smooth transition into the new (delayed) framework.[1] In the rare case that a device has an EC-verification as set out in Annex IV to the MDD, it can only be placed on the market until May 27, 2022 (Article 120 (2) MDR).

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Stephan is counsel at Morrison Foerster’s German office in Berlin. He focuses on advising major German and international clients with regard to drafting and negotiating complex technology-related agreements and on matters concerning cloud computing, software, e/m-commerce, digital media, intellectual property rights, consumer rights, electronic communication, big data and cyber security requirements.

Stephan Kreß

Stephan is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising major German and international clients with regard to drafting and negotiating complex technology-related agreements and on matters concerning cloud computing, software, e/m-commerce, digital media, intellectual property rights, consumer rights, electronic communication, big data and cyber security requirements.

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 6 of 6)

In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern 

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 6 of 6)

On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products. Speakers included Morrison & Foerster partners Bethany Hills and Wolfgang Schönig as well as special guest Corey McCann, president and CEO of Pear Therapeutics, in a fireside chat at the end of the program. Globally, the convergence of software technology and life sciences creates a massive opportunity for growth, and the market for these products is growing exponentially. Both the U.S. Food and Drug Administration (FDA) and European regulators have focused on establishing a regulatory framework for oversight of SaMD.After key definitions and concept overviews by the McKinsey team, Bethany Hills set the foundation of the FDA’s evolution in regard to SaMD in the United States and provided insights into the specific pathways impacting digital therapeutics. The FDA has not specifically defined SaMD, instead relying in the guidance documents on the definition provided by the International Medical Device Regulators Forum (IMDRF), which define the term as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. In essence, the software must act on its own, and have indications or be intended for the diagnosis, treatment, prevention, or monitoring of a condition. Medical devices in the United States are assigned one of three regulatory classes based on the risk and safety and effectiveness of the device. Most SaMD would fall under Class I or II, which then determines the type of submission required for authorization to market, including the 510(k) and De Novo pathways. Most devices are cleared under the 510(k) pathway; however, that trend is changing more recently, with many de novo submissions and authorizations involving SaMD. Areas to keep a close eye on include FDA’s finalization of its Clinical Decision Support Software Guidance, currently in draft form, and the Pre-Certification Pilot Program that could significantly impact SaMD if implemented outside the pilot program, by providing a faster, more efficient pathway to FDA authorization. The FDA does not make reimbursement-related decisions, however, a recent <a target="_blank" href="https://www.federalregister.gov/documents/2021/01/14/2021-00707/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and">CMS Final Rule</a> creates the Medicare Coverage of Innovative Technology (MCIT) pathway that will result in four years of national Medicare coverage starting on the date of the FDA’s market authorization of a device holding a Breakthrough Device Designation.  Providing the European perspective, Wolfgang took the stage to discuss the EU’s current regulatory landscape, and reimbursement for Digital Health Apps in Germany. The EU Medical Device Directive (MDD) will soon be replaced, effective May 26, 2021, by the EU Medical Device Regulation (MDR), directly applicable across the EU and significantly stricter for medical device software (MDSW) in three areas: prediction and prognosis applications, impact on the Class I categorization, and enhanced quality and safety requirements. After a review of the MDSW classifications and key changes to the Quality Management Systems, including more stringent requirements for Post-Market Surveillance activities, additional responsibilities along the supply chain, and stricter timeframes for document retention and incident reporting, the discussion turned to Unique Device Identification, which aims to enhance the effectiveness of post-market safety-related activities and traceability. Finally, the discussion focused on the application requirements for low risk apps (Class I or IIa) to receive reimbursement in Germany per the regulation on the Eligibility of Digital Health Applications for Reimbursement by the State Health Schemes (DiGAV), including certain interoperability requirements with the Electronic Patient File system, data protection requirements, and positive healthcare effects to be shown.Below are some highlights from the Q&A:1. Are there exceptions for software developed in a research setting/environment?a. In the United States, a software product can be used in a research and development setting without requiring the FDA’s authorization. However, there are nuances if the research setting involves human subjects.b. In the EU, the MDR generally applies to SaMD that is made available to others, including in a research setting. Yet, one important exception allows for the in-house development and use of SaMD in health institutions with only limited regulation (Article 5(5) MDR). The requirements to fulfill in order to benefit from this exception are rather strict. Most notably, they include that the specific needs for the targeted treatment cannot be met by any equivalent device on the market and that the SaMD is not transferred to another legal entity.2. Is there different regulatory treatment if the use of the medical device is for healthcare providers only vs. patients?a. In the United States, the answer depends on the category of the SaMD. For example,<a href="https://www.fda.gov/media/109618/download" target="_blank"> Clinical Decision Support</a> software has different standards applied for provider users v. patient users.b. The MDR in the EU does not expressly distinguish between groups of end-users; however, some regulatory requirements can make differentiated measures necessary. For example, instructions for use under certain circumstances may be delivered to professionals in electronic form while non-professional users can demand a printed version. Additionally, member states of the EU can decide that the instructions must be delivered in a certain language. In this regard, Germany requires documents to be in German for non-professional users but deems English instructions sufficient for professional users.3. What are some of the reimbursement options for SaMD companies?a. Reimbursement options and pathways seem elusive for SaMD companies, although there does seem to be an evolving path for the category of digital therapeutics.b. In the EU, reimbursement options for SaMD are not harmonized, i.e., each member state has established its own rules on the matter. This means, that the requirements to qualify for reimbursement differ significantly from country to country. Since the COVID-19 pandemic has seriously boosted the acceptance and demand for digital health products, some member states are currently revisiting their frameworks for reimbursement for SaMD. Germany, for instance, has enacted the DiGAV under which certain low risk apps (Class I or IIa) can receive reimbursement (see above and <a href="https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/DiGA_Guide.pdf;jsessionid=04D2120BC0B889420CDDF02A652FA0D2.2_cid354?__blob=publicationFile&v=2" target="_blank">here</a>).4. What are the implications of GDPR on SaMD regulation in Europe? Among other issues to consider, the GDPR sets up restrictions for transfers of personal data from within the European Union to a country outside the EU. Please note that the meaning of “transfer” is understood quite broadly, and includes situations in which personal data becomes accessible to a third party, even if such third party does not actually access the data. Cross-border data transfers require a so-called transfer mechanism, which can usually be an adequacy decision by the European Commission for a particular country, EU model clauses, or binding corporate rules. Following the judgment of the European Court of Justice in the case “Schrems II,” in which the Court invalidated the EU-U.S. Privacy Shield, transfers to the United States have become particularly onerous to facilitate. Furthermore, EU member states may have introduced additional restrictions for transfers in the context of SaMD. For example, in Germany under the DiGAV, data transfers to the United States or any other non-EU country without an adequacy decision by the EU Commission is generally impossible. However, the German Federal Institute for Drugs and Medical Devices has issued guidance explaining under which circumstances it may be possible to use EU subsidiaries with parent companies in non-EU countries. More information is available <a href="https://www.bfarm.de/SharedDocs/Downloads/EN/MedicalDevices/Data_Processing_outside_of_Germany_FAQ.pdf?__blob=publicationFile&v=3" target="_blank">here</a>. Please note, however, that this topic is hotly debated and far from settled.5. How critical is HIPAA for companies in the U.S. market? HIPAA is a critical set of federal standards for privacy and security of protected health information. However, HIPAA is only one piece of the patchwork of privacy and security laws in the United States spanning federal and state requirements that could be applicable to SaMD.Related posts <a target="_blank" href="https://lifesciences.mofo.com/topics/Progress-and-Concerns-of-FDAs-Plan-for-Regulatory-Oversight-of-Artificial-IntelligenceMachine-Learning-AIML-Based-Software-as-Medical-Devices-SaMDs.html">FDA’s Plan for AI/ML-Based Software as Medical Devices: Progress and Concerns</a><a target="_blank" href="https://lifesciences.mofo.com/topics/FDA-Clinical-Decision-Support-Software-vs-EUs-Medical-Device-Regulation.html">FDA Clinical Decision Support Software Vs. EU’s Medical Device Regulation</a>  MoFo Life Sciences also features a six-part blog series discussing software as a medical device in Europe and the current regulatory landscape in more detail. Catch-up on parts 1-5 below and subscribe to our blog to receive the latest updates. <ul><li><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html">New regulatory regime about to enter into force</a></li><li><a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html" target="_blank">A more detailed approach to the “intended purpose” </a> </li><li><a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html" target="_blank">Risk class re-categorization</a></li><li><a href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html" target="_blank">Additional quality assurance and documentation requirements for MDSW</a></li><li><a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe--New-Regulatory-Regime-About-To-Enter-Into-Force--Part-5-of-6.html" target="_blank">Introduction of a Unique Device Identification requirement for MDSW</a></li></ul>

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Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on reg

Global HealthTech CEO Connect: Software as a Medical Device in the U.S. and EU Recap