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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Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) 

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Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6)

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 3 of 6) | MoFo Life Sciences

Stephan Kreß

Robert Grohmann

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in <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">part 2</a> 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" target="_blank">series of articles</a>, in this part 3, we now turn to the issue of risk classification of such MDSW under the MDR.<h4>INTRODUCTION</h4>Under 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”), most stand-alone MDSW (i.e., MDSW not implemented in a more complex medical device, such as control software) including, for instance, a mobile app that allows users to take pictures of moles on their skin and evaluates whether it is a melanoma, are classified as Class I medical devices and therefore subject to self-certification (see <a href="https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_borderline_manual_05_2019_en.pdf" target="_blank">Manual on Borderline and Classification, Version 1.22</a>, page 81). This is likely going to change under the MDR, coming into full effect on May 26, 2021. Due to new classification rules, significantly more stand-alone MDSW will likely be classified as Class IIa or higher. This means that obtaining CE markings for stand-alone MDSW will more often require involvement of a notified body with an increasing level of scrutiny depending on the determined class.<h4>1. THE EU RISK CLASSIFICATION SYSTEM</h4>Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four risk classes: Class I (lowest-risk class), Class IIa, Class IIb, and Class III (highest‑risk class).These risk classes determine which conformity assessment procedures are required to obtain CE markings and range from self-certification (for Class I) to a full review of the technical design and manufacture of the specific device by a notified body (for Class III). Self-certification includes compliance with general safety and performance requirements, performance of clinical evaluation, preparation of technical documentation, and the issuance of an EU Declaration of Conformity. In addition to that, a Class IIa examination requires that a notified body examines the quality management system (“QMS”) and the technical data of one representative product sample per product category. In Class IIb, examination is conducted per generic product group, and in Class III, the QMS and technical data of every product must be examined.<h4>2. AMENDED RISK CLASSIFICATION SYSTEM FOR MDSW UNDER THE MDR </h4>The classification of MDSW under the MDR will take place in accordance with Annex VIII of the MDR. For classification purposes, MDSW, just like hardware devices, is considered an active device and can be classified in all four risk classes. Depending on whether the MDSW is a stand‑alone MDSW, an accessory to a hardware device, or drives or influences the use of a hardware device for a medical purpose, Rules 9, 10, 11, 12, 13, 15, and 22 of Annex VIII, Chapter 3 to the MDR (the “Rules”), can be relevant. Stand-alone MDSW, such as most health apps, will be classified independently from any hardware medical device (Annex VIII, Chapter 2, para. 3.3 of the MDR) and will thus mainly be governed by Rule 11 of Annex VIII to the MDR (“Rule 11”).According to Rule 11:(a)   Software intended to provide information that is used to take decisions with diagnosis or therapeutic purposes is classified as Class IIa, except if such decisions have an impact that may cause:<ul><li>Death or an irreversible deterioration of a person’s state of health, in which case it is Class III; or </li><li>A serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as Class IIb. </li></ul>(b)   Software intended to monitor physiological processes is classified as Class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as Class IIb.(c)   All other software is classified as Class I.In light of the foregoing it seems that a significant portion of stand-alone MDSW will fall in the higher risk classes IIa to III, as most of the stand-alone MDSW with an intended medical purpose will likely also provide information that is used for decision-making with diagnosis or therapeutic purposes.<h4>3. A MORE DIFFERENCIATED APPROACH TO CLASSIFICATION</h4>However, classification of stand-alone MDSW under the MDR will not be black and white. Guidance and a more detailed approach on risk categorizations and classification under Rule 11 is provided by the European Commission’s <a href="https://ec.europa.eu/docsroom/documents/37581" target="_blank">Guidance on qualification and classification of software in Regulation (EU) 2017/745-MDR and Regulation (EU) 2017/746-IVDR</a> (in the version of October 2019; “MDCG 2019-11”). Although the MDCG 2019-11 are not binding, as official documents, they should be taken into consideration when assessing software for classification under the MDR.According to the MDCG 2019-11, Rule 11 mirrors the regulatory guidance developed at the international level — more specifically, in the context of the International Medical Device Regulators Forum (“IMDRF”). The IMDRF framework for risk categorization of software as a medical device (SaMD) (“IMDRF Risk Framework”) categorizes the risk of software based on the combination of two factors:        i.            the significance of the information provided by the software to the healthcare decision,and      ii.            the healthcare situation or patient condition.In this regard, the IMDRF has developed a table for assisting manufacturers in identifying the appropriate risk category for their MDSW. This table was further supplemented by the European Commission and included in Annex III to the MCDG (“Amended IMRF Framework”) to reflect the corresponding MDR risk classes according to Rule 11:<div class="embedded-entry redactor-component block-entry" type="entry" data-sys-entry-uid="blt884195cd18c433c7" data-sys-entry-locale="en-us" data-sys-content-type-uid="image_content" sys-style-type="block"><div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt8bcd954f749ec7e1/62731787b5ad5f2863c59610/annexiii2.png?format=auto&amp;quality=60" alt="Annex III Table"></div></div>Source: Annex III of the MDCG 2019-11The Amended IMRF Framework allows a more differentiated approach to risk categorization and classification of stand-alone MDSW under Rule 11. For example, a mobile app intended to analyze a user’s heartbeat, detect abnormalities, and inform a physician accordingly may be classified as Class IIb per Rule 11(a), if the information provided by the software is intended to guide the physician in the diagnosis, because the information drives clinical management and the health care situation can be critical.[1] Yet, if the MDSW were intended to automatically adapt treatment (e.g., medication plans) of, for example, cardiac arrhythmias, it may be classified as Class III per Rule 11(a), as not only would the health care situation be critical but the MDSW would also be used to take immediate action to treat a disease or a condition.On the other hand, MDSW intended to rank therapeutic suggestions for a health care professional based on patient history, imaging test results, and patient characteristics (e.g., a MDSW that lists and ranks all available chemotherapy options for BRCA-positive individuals) may be classified as class IIa per Rule 11(a) since, albeit cancer being a critical disease, the MDSW only informs clinical management about the options.[2]It must be noted that the table does not take into account MDSW, which is Class I, as Class I MDSW falls outside the IMDRF risk categories.<h4>4. ROOM FOR CLASS I CLASSIFICATION OF MDSW</h4>However, a classification in Class I still remains possible. This will be the case for stand-alone MDSW that — even though intended for medical purposes — stays under the threshold set out by Rules 11(a) and (b) and thus falls under Rule 11(c). Manufacturers of MDSW should therefore not assume by default that any MDSW must at least be Class IIa but will still find it worthwhile to carefully assess whether the features of the software do not rather warrant a Class I categorization.For example, an app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm in which the user inputs her own health data (i.e., basal body temperature (BBT) and menstruation days) to track and predict ovulation and in which the fertility status of the current day is reflected by one of three indicator lights (i.e., red = fertile, green = infertile, or yellow = cycle fluctuation) may be regarded as Class I, as this MDSW is neither used to take decisions with diagnosis or therapeutic purposes, nor does it monitor physiological processes. Another example may be a mobile app that assists users with a medical condition to self-manage their condition or to pursue a healthier lifestyle based on data provided (e.g., sleeping hours, heart beat frequency) and preferences selected by the user, including increased body activity or recommendations concerning regular sleep.It is important to note that, other than the MDCG 2019-11, which are not binding, there are no conclusive guidelines as of now, and naturally no examples of enforcement or relevant court decisions applicable to Rule 11 due to its significant deviances from the framework under the MDD. Therefore, practical appliances will only clarify the continued relevance of Class I classifications when the MDR will be applicable.<h4>CONCLUDING REMARKS</h4>Developers and operators of new stand-alone MDSW not yet placed on the EU market need to brace themselves for the new, more rigid classification system under the MDR, which will likely make more products subject to the direct involvement of the notified bodies. Therefore, obtaining CE markings will become more complex and time consuming. A careful assessment should be made, taking into account the intended purpose and the functions of the stand-alone MDSW and by applying the Amended IMRF Framework. Under certain requirements, stand-alone MDSW already on the EU market and classified as a Class I medical device under the MDD will only be required to comply with the new rules as of May 26, 2024. We will discuss these requirements in more detail in Part 6 of our series of articles on Software as a Medical Device in Europe, available on March 19, 2021.  [1] See Annex IV of the MDCG 2019-11on classification examples.   [2] See Annex IV of the MDCG 2019-11on classification examples.

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