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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The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies. The benefits provided by ML are wide-ranging and include providing earlier and more accurate diagnoses by detecting patterns in clinical data associated with disease, improving surgical outcomes through preoperative and intraoperative surgical guidance, and enabling the development of personalized diagnostics and therapeutics. Medical device companies should look to build a robust patent portfolio for their ML inventions. This raises the question of how to build a patent portfolio for ML inventions in the medical device field. ML involves the training of mathematical models to draw conclusions from data, such as medical images or other clinically relevant data. While mathematical models by themselves are not eligible for patenting, their application to achieve practical results is patentable. Broadly speaking, patents for ML‑based inventions fit into three broad categories. <ul><li>Applications of ML. This category includes patents directed to novel results achieved using ML. Examples of ML applications in the medical device field include automatic identification of anatomical structures in imaging, automatic diagnoses from patient data, and patient recovery tracking. Patents in this category are often the most valuable, both because of their breadth of coverage and because infringing activity can be readily detected, often from advertising materials and use of the product. </li><li>Structure of the ML model. The structure of the ML model refers to the structure of the mathematical algorithm itself and how it processes data. Although mathematical algorithms by themselves are not eligible for patenting, the application of a novel ML model to a practical application can be patented. Patents in this category are often less valuable because their scope is narrower and detection of infringement is more difficult.</li><li>ML model training. This category includes patents directed to the process for training an ML model to achieve its purpose. Training of an ML model is critical to how well it performs and thus can be one of the most important aspects of developing an ML solution. However, infringement of patents in this category is often very difficult to detect because the process for training is typically not advertised or apparent from the use of the product.</li></ul>Although patents directed to the applications of ML are typically the most valuable, medical device companies should also pursue patents to ML model structure and training because these patents contribute to the benefits that a robust patent portfolio provides, including:<ul><li>Deterring others from practicing the invention. Patents, of course, can be used to prevent others from making and using an invention. However, patents that are unlikely to ever be asserted still serve as a deterrent from copying and as a roadblock to the ability of competitors to innovate their own products. </li><li>Providing freedom to operate. Filing a patent application ensures that an invention is in the public space and thereby cannot be patented by anyone that invents the same thing later. Preventing others that create the same invention at a later date from patenting the invention ensures a company’s ability to practice its own technology. This is an important countervailing consideration to keeping an ML invention as a trade secret since trade secret protections do not protect against independent invention and patenting.</li><li>Advertising to investors. This benefit is most relevant to emerging companies looking for investments or acquisitions. Patents can serve as advertisements of the technical capabilities and sophistication of a company. They provide investors with the ability to “look under the hood” and make their own independent assessment of the value of the underlying ML technology.</li></ul>Given the increasing importance of ML in the medical device market, robust patent portfolios protecting ML innovations can help ensure that medical device companies reap the benefits of their valuable innovations.

The Importance of Patents for ML-Based Medical Device Inventions

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Christopher Gloria is a partner in the firm’s Patent Group. Mr. Gloria’s practice concentrates on domestic and international patent prosecution, IP due diligence, and IP litigation support including patent infringement and validity determinations.

Christopher Gloria

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The Importance of Patents for ML-Based Medical Device Inventions

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The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies.

Our Federal Circuitry blog recently discussed the Court's decision in <a href="https://cafc.uscourts.gov/opinions-orders/19-2054.OPINION.8-11-2022_1990706.pdf" target="_blank">Hologic, Inc. v. Minerva Surgical, Inc.</a>, No. 19-2054.You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post-MinervaYou have to feel a little sorry for a party that beats the incredible odds of getting Supreme Court review only to end up with the same result. That’s what happened in our case of the week. Unless you’ve been living under a rock (or the proverbial equivalent of a rock in patent-land—the MPEP maybe), you’re no doubt aware of one of the few relatively recent Supreme Court patent cases: <div><a href="https://www.supremecourt.gov/opinions/20pdf/20-440_9ol1.pdf" target="_blank">Minerva Surgical, Inc. v. Hologic, Inc. </a>(And once again, here’s where a few readers shed a tear for what could have been in American Axle.) As a recap, the Supreme Court granted cert to decide whether the doctrine of assignor estoppel found any support in patent law. Assignor estoppel precludes an assignor of a patent from later challenging that patent’s validity. At least initially, smart money was on the “no” side, as nothing in the U.S. Code expressly provides for assignor estoppel, and this is supposedly a textualist Supreme Court.</div>

Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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Brian Matsui co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Brian is a go-to appellate advocate for sophisticated clients in complex appeals nationwide. 

Brian R. Matsui

Brian Matsui is a partner in Morrison Foerster’s Appellate and Supreme Court practice. For nearly 20 years, Brian has been a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Clients turn to Brian for his substantial experience in patent appeals in the Federal Circuit. He has argued more than 10 times in that Court, winning appeals from both district courts and the Patent Trial and Appeal Board. Brian excels at applying significant legal principles to complex technologies in a way that distills them for the Court. He has done so for companies in a myriad of industries, including mobile device manufacturers, pharmaceutical companies, medical device companies, memory manufacturers, movie studios, and software companies.

Brian Matsui

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Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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For most of us, we’re stuck in the August heat, on delayed European vacations, or hopefully just hanging out at the beach. But for the Court it still was work as usual, including a return trip to the Federal Circuit for the defendant in Minerva. Below we provide our usual weekly statistics and a detailed discussion of our case of the week—our highly subjective selection based on whatever case piqued our interest.

Research assistant Nicole Gebert contributed to this article.<a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html">Part 1</a> of this article discussed the background and purpose of the <a href="https://eur-lex.europa.eu/eli/reg/2017/746/oj" target="_blank">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system, conformity assessments, and the role of notified bodies. This was followed by <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">part 2</a>, where we discussed clinical evidence, post-market surveillance, and transition periods. We will now focus specifically on requirements for medical device software (MDSW) as an IVD (IVD-MDSW) and the delimitation between the application of the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">EU Medical Device Regulation (EU) 2017/745</a> (MDR) and application of the IVDR to a software device.<h2>Qualification as IVD-MDSW</h2>As already mentioned in<a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank"> part 1</a> of this article, the expanded IVDR definition of “in vitro diagnostic medical devices” in Article 2 (2) now explicitly includes software.IVD-MDSW usually occurs in the following forms:<ul><li>Software itself as an IVD</li><li>Software as an accessory for an IVD</li><li>Software driving or influencing the use of an IVD</li></ul>The first stage in determining whether the software is an IVD-MDSW subject to the IVDR is to confirm that the software is a medical device (MDSW).<ul><li>The Medical Device Coordination Group (MDCG) guideline <a href="https://ec.europa.eu/docsroom/documents/37581?locale=en" target="_blank">MDCG 2019-11</a> clarifies that MDSW is software intended to be used alone, or in combination, for a purpose as specified in the definition of “medical device” in the MDR or IVDR (for more information on the intended purpose of MDSW under the MDR, see part 2 our <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">MDR blog series</a>). In general, software that processes, analyses, creates, or modifies medical information will qualify as MDSW if it is intended to have a medical purpose. Software for non-medical purposes, or for general purposes, even when used in a healthcare setting, or software intended for well-being purposes, is not covered by the MDR and IVDR. Software that merely used to store, archive, or performs simple searches on medical data does not qualify as MDSW.</li></ul>Second, the software must meet the following criteria to qualify as IVD-MDSW:<ul><li>The MDSW provides information within the scope of the definition of IVDs; </li><li>MDSW creates information based on data obtained by an IVD only; or</li><li>The intended purpose of the MDSW is substantially driven by data sources coming from IVDs.</li></ul>In accordance with the second step, an MDSW that analyses maternal parameters such as age, concentration of serum markers, and information obtained through various IVD assays, as well as fetal ultrasound examination to evaluate the risk of trisomy 21, may be considered an IVD-MDSW as the intended purpose is substantially driven by IVD data.MDSW that does not fulfill this second step is covered exclusively by the MDR. This includes, for example, MDSW that assesses the level of risk to initiate care processes that help reduce intensive care unit (ICU) transfers, readmissions, adverse events, and the duration of stay, by considering risk assessment parameters like respiratory rate, heart rate, blood pressure, and SpO2, by default, and can be configured by the user to include other parameters as well, including results from in vitro medical diagnostic devices. This MDSW would fall under the MDR as (i) the data is obtained from both IVDs and medical devices, and (ii) the data obtained from the IVD is not critical to the output, so the information derived from the medical device is more relevant to the intended purpose.<h2>Risk Classification of IVD-MDSW According to the IVDR</h2>In <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank">part 1</a> of this article, we discussed the adoption of a new classification system. We also pointed out that the IVDR does not contain software-specific classification rules, like Rule 11 of Annex VIII to the MDR. Therefore, the classification of MDSW under the IVDR requires consideration of all classification and implementation rules of Annex VIII to the IVDR.The classification system of the IVDR considers the intended purpose of the device and the inherent risks, and groups devices into four different risk classes (classes A to D) in ascending order of their risk intensity. For example, software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O, and HIV-2 in human serum and plasma, may be a device intended to be used for determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management under rule 1 of Annex VIII to the IVDR and would thus be classified in class D. At the same time, the IVD-MDSW referred to above, which uses maternal parameters and information obtained through fetal ultrasound examination to evaluate the risk of trisomy 21, may be considered a device that is intended for screening for congenital disorders in the embryo or fetus under Rule 3 (l) of Annex VIII to the IVDR and should thus be in class C.However, given the close nature of the MDR and the IVDR, there are of course similarities in the regulation of MDSW. Very similar to the risk assessment under the software-specific rule 11 of Annex VIII to the MDR (i.e., which effectively provides for class IIa ranking as a default result and therefore requires notified body review of most MDSW), the risk assessment of MDSW under the IVDR will in most cases result in a class B ranking (or higher) and therefore also require the IVD-MDSW to undergo an conformity assessment by a notified body. This is because IVDs, including IVD-MDSW, which are not covered by any specific classification rule, fall under class B by default (Rule 6 of Annex VIII of the IVDR).<h2>Technical Documentation for IVD-MDSW</h2>Before placing IVDs on the market, most manufacturers will need to get their technical documentation assessed by a notified body (see <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank">part 1</a> of this article for IVDR conformity assessment routes). The IVDR stipulates several software-specific requirements for the technical documentation in Annex II:<ul><li>The device description and specification should include a description of any software that drives the device or influences use of the device (Annex II 1.1.k).</li><li>For IVDs that incorporate software, the design information should include a description of any software to be used with the device, as well as an overview of the entire system. If the IVD uses software for objective data interpretation, or if the software is independent of any other device, a description of the data interpretation methodology, namely the algorithm, should be included (Annex II 3.1).</li><li>The documentation should further contain evidence of software validation as used in the finished device, as well as address all hardware configurations and, where applicable, operating systems identified in the labeling (Annex II 6.4, EN ISO/IEC 62304 is considered the state of the art approach).</li></ul>Several guidelines for IVDR technical documentation submissions have been issued by notified bodies and should be taken into consideration when dealing with the respective notified body (e.g., TÜV Rheinland, BSI).<h2>Introduction of a Unique Device Identification Requirement for IVD-MDSW</h2>The IVDR, like the MDR, introduces the Unique Device Identification (UDI) system. Annex VI Part C 6.2 of the IVDR addresses the UDI assignment for software specifically. In accordance with the IVDR, software that is commercially available on its own (i.e., standalone IVD-MDSW), as well as software that constitutes an IVD device, shall be subject to UDI requirements. These requirements are identical for MDSW under the MDR and for IVD-MDSW under the IVDR. More details on how to identify software devices can be found in <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">part 5</a> of our blog series on the MDR.<h2>IT Security</h2>Among the many novelties introduced, the IVDR and the MDR aim to ensure that devices placed on the EU market are suitable for the new technological challenges associated with cybersecurity risks.IVDs must thus be designed and manufactured in a way that removes or reduces risks associated with the possible negative interaction between software and the IT environment in which it operates and interacts (Annex I Chapter II 13.2.d). Manufacturers must establish, implement, document, and maintain a risk management system. Particularly with the complexity of software development, software configuration, and interdependencies between software components, IVD-MDSW is afflicted with security vulnerabilities. It is therefore considered more reasonable that software as such is subject to foreseeable misuse. Manufacturers should foresee or evaluate the potential exploitation of those vulnerabilities.Manufacturers must also develop and manufacture IVD-MDSW in accordance with the state of the art, while taking into account the principles of development lifecycle and risk management, including information security, verification, and validation. Manufacturers also need to set out minimum requirements concerning IT network characteristics and IT security measures, including protection against unauthorized access (Annex I Chapter II (16) IVDR).Further information can be found in the MDCG Guidance on Cybersecurity for medical devices (<a href="https://ec.europa.eu/health/system/files/2022-01/md_cybersecurity_en.pdf" target="_blank">MDCG 2019-16</a>).<h2>Performance Evaluation of IVD-MDSW</h2>Although the IVDD already required a performance assessment, it was only implied, not explicitly stated, and primarily concerned with the analytical performance of the device. Under the IVDR, any software that qualifies as an IVD must meet all clinical evidence and performance evaluation principles explicitly outlined in Article 56 (1) and Annex XIII of the IVDR. The MDCGs Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (<a href="https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf" target="_blank">MDCG 2020-1</a>) aims to provide the framework for the determination of the appropriate level of clinical evidence required for MDSW to fulfill the requirements set out in the IVDR (and MDR).Although the definition of clinical evaluation in the MDR and performance evaluation in the IVDR are not identical, sufficient clinical evidence is expected in both cases to demonstrate compliance with the relevant general safety and performance requirements.When collecting clinical evidence for IVD-MDSW, three key elements should be taken into account:<ul><li>Scientific validity;</li><li>Analytical performance; and</li><li>Clinical performance.</li></ul>Part A of Annex XIII applies primarily to the pre-market phase and defines performance evaluation as a three-step process: (i) drafting a performance evaluation plan, (ii) collecting data to demonstrate scientific validity and analytical and clinical performance, and (iii) evaluating and documenting the data in a performance evaluation report.Part B of Annex XIII concerns the post-market phase and outlines the requirements for post-market performance follow-up. This concept was not included in the IVDD, but is in line with the practice of many manufacturers to conduct a periodic “state of the art” review.<h2>Concluding Remarks</h2>Under the IVDR, IVD-MDSW is subject to several software specific requirements. As most IVD-MDSW will likely end up in class B or higher, manufacturers will also need to undergo notified body review in order to be able to place IVD-MDSW on the market. Therefore, it can be expected that a number of manufacturers will make use of the transition periods discussed in <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">part 2</a> of this blog series. However, as discussed in more detail in <a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe-new-regulatory-regime-to-enter-into-force-part-6.html" target="_blank">part 4 of our blog series on MDSW under the MDR</a>, in particular MDSW manufacturers should be aware of the implications that come along with the use of transition periods as the IVD-MDSW may not undergo any significant changes to its design or intended purpose in order to benefit from such transition periods.

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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Counsel

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: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

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

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Research assistant Nicole Gebert contributed to this article.
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulati

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

Research assistant Nicole Gebert contributed to this article. After having discussed the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies in part 1 of our 3 part series on the entering into force of the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128 " target="_blank">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR), we will now (i) explore key changes regarding clinical evidence and post-market surveillance, and (ii) discuss applicable transition periods.<h2>Clinical Evidence, Performance Evaluation, and Performance Studies</h2>Ensuring that the clinical evidence can stand up to the scrutiny of the notified bodies will be one of the biggest challenges for manufacturers in IVDR compliance. It is the responsibility of the manufacturers to determine whether they have adequate clinical and performance data to demonstrate conformity with the relevant safety and performance requirements. According to the IVDR, clinical evidence must demonstrate a continuous process of performance evaluation and must support the intended purpose of the device as stated by the manufacturer. Gradually, the level of clinical evidence needed to demonstrate device conformity increases in line with the risk class. A manufacturer must document the clinical evidence in a performance evaluation report once they are satisfied they have all of the data needed to support compliance with the IVDR. The report must include the scientific validity report, the analytical performance report, the clinical performance report, and an assessment of those reports allowing demonstration of the clinical evidence. More detailed information on clinical evidence can be found in the <a target="_blank" href="https://ec.europa.eu/health/system/files/2022-01/mdcg_2022-2_en.pdf">MDCG Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)</a> from January 2022.<h2>Post-Market Surveillance</h2>Similar to the MDR, the IVDR too places a greater emphasis on life-cycle management and continuous product evaluation than the IVDD. In this context, manufacturers are required to have a quality management system (QMS) in place (Article 10 IVDR). As part of the QMS, manufacturers are obligated to plan, establish, document, implement, maintain, and update a post-market surveillance system for each device in a manner that is proportionate to the risk class and appropriate for the type of device (Article 78 (1) IVDR). The requirements for the post-market surveillance system are described in Articles 79-81, Annex III, and Annex XIII of the IVDR. The requirements vary according to the risk class. Many aspects of the IVDR post-market surveillance requirements resemble the requirements of the MDR (for more information on QMS and post-market surveillance under the MDR, please see our previous blog post <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">here</a>). Similar to the MDR’s post- market clinical follow-up, the IVDR stipulates that a post-market performance follow-up (PMPF) is required to ensure that an IVD’s safety, performance, and clinical evidence remain based on factual evidence throughout its expected lifespan and that its benefit-risk ratio remains acceptable. In some cases, PMPF can be justified as not required (see Annex III 1b and Annex XIII Part B 8).<h2>Unique Device Identification System</h2>The identification and traceability of IVDs will be improved under the IVDR with the introduction of unique device identifiers (UDI). As laid out in Article 24 IVDR, each IVD must have a UDI composed of two parts: a UDI that is specific to a manufacturer and a device that provides access to the information set forth in Part B of Annex VI IVDR, and a unique device production identifier that identifies the unit of device production and, if applicable, the packaged devices, as specified in Part C of Annex VI IVDR. Manufacturers are responsible for entering and maintaining the necessary data in a UDI database, which is part of the <a target="_blank" href="https://ec.europa.eu/tools/eudamed/#/screen/home">European Database on Medical Devices</a> (EUDAMED). The UDI requirements in the IVDR are in line with the requirements set out by the MDR, which we addressed in more detail in part 5 of our MDR blog series that can be found <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">here</a>.<h2>Transition Periods</h2>As mentioned above, the Commission proposed a delayed, progressive roll-out of the IVDR in October 2021. The rationale behind this proposal is that due to the resources diverted to address the COVID-19 pandemic and the significant changes introduced by the IVDR, Member State authorities, healthcare facilities, notified bodies, and economic operators would not be able to fully comply with the requirements of the IVDR at the time of application on May 26, 2022. In particular, the inadequate number of notified bodies was highlighted, making it impossible to guarantee that the conformity assessments would be carried out in time. After immense stakeholder pressure, the Commission acknowledged that this situation could lead to a significant disruption in the supply of a multitude of IVDs on the market both for health institutions and for the public (<a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0627&qid=1634552565285">Commission proposal</a>, <a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209">press release</a>, and <a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210">Questions & Answers</a> dated October 14, 2021). The proposal was adopted by the European Parliament in December 2021 (<a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/IP_21_6965">Commission press release</a>, <a target="_blank" href="https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html">EU Parliament Resolution</a> of December 15, 2021). Under the amended regulations, the dates on which certain requirements might apply are revised.The extended transition periods apply only to legacy IVDs, meaning devices that were certified or declared compliant before May 26, 2022. Therefore, all devices newly placed on the market after May 26, 2022, must be classified and certified in accordance with the IVDR rules.Furthermore, the IVDR will also immediately apply to any device for which an IVDD declaration of conformity was drawn up before May 26, 2022, and which must be reclassified as a class A non-sterile device under the IVDR. This is because such a device does not require a notified body review and, according to the rationale behind the transition periods, will thus not contribute to the notified bodies becoming a bottle neck that slows down market access or being subject to the same.If a manufacturer has drawn up an IVDD declaration of conformity without the involvement of a notified body before May 26, 2022, and if, under the IVDR reclassification, the device must be classified as a class A sterile device or higher and thus undergo conformity assessment with a notified body, according to the amended Article 110 (3) IVDR, the following new transition periods apply:<ul><li>May 26, 2025, for class D devices; </li><li>May 26, 2026, for class C devices;</li><li>May 26, 2027, for class B devices; and</li><li>May 26, 2027, for class A devices placed on the market in sterile condition. </li></ul>For IVDs which have been certified by an IVDD notified body before May 26, 2022, according to Article 110 (2), the following transition periods apply:<ul><li>Certificates issued by notified bodies under the IVDD prior to May 25, 2017, will remain valid until the date indicated on the certificate (with no amendment of the transition period). It should be noted, however, that IVDD certificates are usually valid for a maximum of five years according to Article 9 (10) IVDD.</li><li>Certificates issued by notified bodies in accordance with the IVDD from May 25, 2017, and certificates issued under the EC Verification in accordance with Annex VI of the IVDD, will become void at the latest by May 27, 2025. </li></ul>It should be noted that for the aforementioned transition periods to apply, the IVD needs to continue to comply with the IVDD requirements and must not undergo significant changes in its design or intended purpose after May 26, 2022, which in particular for IVD software can be challenging because changes in the intended user groups or changed indications, corrections of errors to minimize risks, changes in the user interface (like changed warning messages), or the use of a different runtime environment will likely be deemed significant according to <a href="https://ec.europa.eu/docsroom/documents/40301/attachments/1/translations/en/renditions/native" target="_blank">MDCG 2020-3 Guidance on Significant Changes</a>. Furthermore, according to Art. 110 (3) IVDR, the IVD manufacturer must comply with post-market surveillance, vigilance, UDI, and market surveillance rules of the IVDR.<h4>CONCLUDING REMARKS</h4> The IVDR brings about increased standards and requirements for IVDs in order for the devices to be placed on the market. Although it can be expected that many legacy IVDs, including IVD software, will benefit from the transition periods, manufacturers will need to assess on a case-by-case basis whether the respective device fulfills the criteria and whether the same can be maintained during the entire transition period (i.e., no significant changes can be made). Furthermore, the transition periods may bring some relief with respect to the certification of IVDs, but they do not necessarily mean that the IVDR requirements do not apply to these devices. Therefore, manufacturers should have adopted IVDR compliance measures by now and should seek. As it can be expected that the run on notified bodies will increase with the end of the transition periods approaching, it would also be advisable to start preparing the transition to IVDR certification and file for the same well in advance of the end of the applicable transition period.

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EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 2 OF 3)

QMSR: Welcomed by the Industry, but Lacking in Practicality

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Research assistant Nicole Gebert contributed to this article. 
After having discussed the general purpose and background of the IVDR, the new definition of IVDs

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE  (PART 2 OF 3)

Research assistant Nicole Gebert contributed to this article.In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the COVID-19 pandemic. But also apart from the pandemic, <a target="_blank" href="https://www.grandviewresearch.com/industry-analysis/in-vitro-diagnostics-ivd-market">the industry is seeing significant growth</a> with the software component of such devices becoming increasingly important with regard to in vitro testing.Similar to other medical devices, the regulatory framework for IVDs in Europe is undergoing significant changes. About a year ago, the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">EU Medical Device Regulation (EU) 2017/745</a> (MDR) entered into force and brought about significant challenges for medical device manufacturers with respect to obtaining medical device certification and post-market surveillance compliance (for more information on the MDR find our previous blog series <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">here</a>). Now the new <a target="_blank" href="https://eur-lex.europa.eu/eli/reg/2017/746/oj">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR) entered into full force and effect on May 26, 2022. Whereas certain legacy devices will benefit from transition periods, all new IVDs and certain low-risk IVDs already on the market are now subject to the IVDR requirements.Key changes that the IVDR brings about for stakeholders in the industry are the following:<ul><li>Broader definition of IVDs; </li><li>New risk-based classification system; </li><li>New conformity assessment procedures;</li><li>New requirements for clinical evidence, performance evaluation, and performance studies;</li><li>Post-market surveillance;</li><li>Introduction of a unique device identifier; and</li><li>Transition periods. </li></ul>This article is split into three parts. In this first part, we will discuss the general purpose and background of the IVDR, the new definition of IVDs, and the conformity assessment in light of the new risk classification as well as the role of notified bodies.In <a target="_blank" href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html">part 2</a> of this article (to be published on June 6, 2022), we will discuss clinical evidence, post-market surveillance (including unique device identifiers (UDIs)), and transition periods.In <a target="_blank" href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force-part-3-of-3.html">part 3</a> of this article (to be published on June 13, 2022), we will cast light specifically on software as an IVD and the delineation between the MDR and the IVDR.<h2>Background and Purpose of the IVDR</h2>In the European Union, before an IVD can be marketed, manufacturers must obtain a CE mark to certify that the device complies with applicable law. The former regulatory regime was based on the European Directive on In Vitro Diagnostic Medical Devices (<a href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31998L0079">IVDD 98/79/EC</a> (IVDD)).The IVDR initially came into force on May 25, 2017, but contained a transition period that (after an extension during the COVID-19 pandemic) ended on May 26, 2022, and completely replaces the IVDD regime. As an EU Regulation, the IVDR does not need to be implemented into national legislation and will be applicable to all members of the EU and EFTA countries immediately. The regulation is designed to create a framework that sets out to improve clinical safety and establish fair market access for IVD manufacturers. The IVDR aims to bring EU legislation in line with technological advances, changes in medical science, and progress in law. Very similar to the MDR, the IVDR focuses on traceability throughout the supply chain, including the use of UDI systems and new clinical evidence standards. More stringent post-market surveillance is required, bringing the regulation of IVDs more closely in line with the requirements for medicines and other medical devices in the EU. It also sets new standards for the application of a CE mark on IVDs to ensure a higher level of quality, safety, and reliability.<h2>New Definition of IVD</h2>The definition of an IVD has been expanded and clarified to include tests intended to predict medical conditions or diseases, as well as companion diagnostics and software. Similar to the definition of a medical device under the MDR, the definition of an IVD is determined by the intended use of the device (more information on the MDR definition is available <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">here</a>). In accordance with MDR Article 2(2), the IVDR covers any IVD intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body for the purpose of providing information on one or more of the following:<ul><li>A physiological or pathological process or state;</li><li>Congenital physical or mental impairments;</li><li>A predisposition to a medical condition or a disease;</li><li>Safety and compatibility for potential recipients;</li><li>Predictions for treatment response or reactions; or </li><li>Definition or the monitoring of therapeutic measures.</li></ul>Furthermore, specimen receptacles are also deemed to be IVDs.Notably, the broadened IVDR definition explicitly includes software. While this is a reaction to the increasing use of software in the field (compared to the situation under the IVDD when it was established in 1998), it is also consistent with the general developments in EU legislation, which are also reflected in the definition of medical devices under the MDR, which explicitly includes software as well (for more information see part 2 of our <a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">MDR blog series</a>). When software meets the above-mentioned criteria and serves a medical purpose, it qualifies as an IVD and must comply with the requirements of the IVDR. Examples of IVD software include (i) systems that support the process from patient sample to patient results, such as laboratory information systems and work area managers, (ii) expert systems that are intended to provide information by capturing and analyzing results obtained through in vitro examinations, and (iii) image management systems that incorporate functions to support post-processing of images for diagnostic purposes. A particular spotlight on these devices will be cast in part 3 of this article (to be published on June 13, 2022).<h2>New Risk-Based Classification System</h2>The IVDR adopts a new classification system that categorizes products into four classes according to their risk characteristics. Taking into account both patient and public health risks, these range from low to high:<ul><li>Class A - Low individual risk and low public health risk;</li><li>Class B - Moderate individual risk and/or low public health risk;</li><li>Class C - High individual risk and/or moderate public health risk; and</li><li>Class D - High individual risk and high public health risk.</li></ul><a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0746&from=de#d1e32-304-1">Annex VIII</a> of the IVDR includes seven classification rules as well as a set of implementing rules, which are intended to aid IVD manufacturers in classifying products according to their risk levels. Additionally, the Medical Device Coordination Group (MDCG), issued its Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 in January 2022, which is a helpful tool for IVD manufacturers to use to self-assess the classification of their products.Under the IVDR, if IVD software is independent of any other device, it shall be classified in its own right (IVDR; Annex VIII 1.4). In contrast to the classification rules under the MDR which provide a specific rule governing the classification of standalone software as a medical device, the classification of software under the IVDR requires consideration of all classification and implementation rules of Annex VIII. Further guidance on the classification of software under the IVDR is provided by the <a target="_blank" href="https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf">MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR</a>, which also contains valuable guidance on the delimitation of software as a medical device versus software as an IVD.<h2>New Conformity Assessment</h2>While the majority of IVDs were permitted to be self-certified by manufacturers under the IVDD, thereby evading the need for a notified body review in order to obtain their CE markings, this will be reversed under the IVDR. Due to the new classification system, the majority of IVDs will undergo a conformity assessment by a notified body, instead of self-certification by manufacturers, before they are deemed to be certified. As can be inferred from the graphic below, only conformity assessment procedures for non-sterile class A devices remain the responsibility of the manufacturer and don’t require the involvement of a notified body. The German notified body <a target="_blank" href="https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification">TÜV Süd</a> estimates that 90 percent of all IVDs will have to be tested by a notified body under the IVDR, compared to less than 15 percent under the IVDD. In order for manufacturers to obtain the declaration of conformity and, where necessary, the CE mark certificate, the IVDR stipulates a conformity assessment route for each risk class.<h2>Notified Bodies</h2>As can be inferred from the above, notified bodies play a critical role in supporting manufacturers in their efforts to place only safe and compliant IVDs on the EU market. The IVDR requires notified bodies to be designated. Notified bodies will have to meet more stringent criteria than under the IVDD, particularly in terms of technical and scientific evaluation proficiency. After a notified body applies for designation, the process can take up to 12 months or more, with both national and European authorities involved in the assessment.The EU Commission maintains a <a target="_blank" href="https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35">list of all IVDR-certified notified bodies</a> on its New Approach Notified and Designated Organizations (NANDO) website. Including the <a target="_blank" href="https://www.3ec.sk/en/news/news/3ec-international-as-ziskalo-autorizaciu-a-notifikaciu-podla-ivdr/">latest designation of a notified body in Slovakia in May 2022,</a> there are only seven notified bodies designated under the IVDR, located in only four countries (Slovakia, France, Germany, and the Netherlands). In October 2021, the <a target="_blank" href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210">EU Commission</a> already addressed this issue as “a grave shortage of notified body capacity” also saying it will be difficult “for manufacturers to conduct the legally required conformity assessment procedures in time.” Consequently, this led to the Commission’s proposal to extend the roll-out periods and introduce new transition periods.<h2>CONCLUDING REMARKS</h2>The IVDR will make a required careful assessment of the intended purpose of IVDs and IVD software inevitable, which must cover every part of their documentation and advertisement. As most IVDs will be reclassified in class B and higher, and therefore require notified body review, the importance of notified bodies within the EU regulatory regime for IVDs will increase significantly. At the same time, only a handful of notified bodies are currently accredited to review and certify IVDs, which creates a bottle neck for IVD manufacturers’ market access. Stakeholders will thus need to plan well in advance of a launch of new IVD products, and it can be expected that many manufacturers will need to rely on transition periods for legacy devices, which will be discussed in detail in part 2 of this series of consecutive articles.

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 1 OF 3)

Is 2021 the Value-Based and Shared Savings Revolution?

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Research assistant Nicole Gebert contributed to this article.
In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such a

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE  (PART 1 OF 3)

On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the <a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">proposed rule</a> titled "Medical Devices: Quality System Regulation Amendments."  If finalized, the proposed rule will rename the current 21 CFR Part 820 as the Quality Management System Regulation (QMSR).  In our previous <a href="https://lifesciences.mofo.com/topics/quality-management-system-regulation-qmsr--harmonizing-the-quality-system-regulation-qsr-with-iso-134852016.html">post</a>, we noted both the industry representatives and the Committee welcomed the proposed rule but agreed that it may have an overly ambitious implementation timeline, especially in light of the ambiguity in some key areas, such as inspection.  These concerns were echoed by FDA, which acknowledged the need to engage in a variety of implementation activities including personnel training, inspection approach finalization, and revising relevant regulations and other documents impacted by the rule.  Below we discuss some of the major concerns raised by both industry representatives and the Committee during the meeting.<ul><li>A one-year transition period would not give the industry sufficient time to be fully compliant with the new requirements.  QMSR proposes a one-year transition time after the final rule goes into effect.  Representatives from both the Advanced Medical Technology Association (“AdvaMed”) and the Medical Imaging and Technology Alliance (MITA) raised concerns about the short implementation timeline. Jamie Wolszon, Vice President of Technology and Regulatory Affairs at AdvaMed, stressed that “there must be a sufficiently long transition period to avoid disruption. We recommend at least a two-year transition period.”  She emphasized that the one-year transition period proposed by FDA would not give the industry enough time to adapt to the new requirements.  The Committee concurred with the industry’s concern that a one-year transition period would be “quite aggressive,” and a two- or three-year transition period would be more appropriate.</li></ul>Moreover, Committee members reminded FDA that the agency will also need a significant amount of transition time once the proposed rule is finalized.  Robert Phillips of Siemens Healthineers, who serves on the Committee, noted that a significant number of FDA guidance documents will all need to be updated to align with the new regulatory citations, definitions, and systems.  He further noted that these updates need to be worked out and made publicly available before a transition can be effected by device firms.  Committee members reminded the agency that when the current Quality System Inspection Technique (QSIT) was launched, it took two to three years for auditors to fully understand and work with QSIT.<ul><li>Industry representatives demand more clarity on the future inspectional approach.  The agency proposes to replace the current inspection approach for medical devices, the QSIT, with a new inspection model and manual to be determined and announced by FDA.  This regulatory vacuum will leave companies with no guidance on how to prepare for future inspections.  For example, it is unclear whether inspection programs under the current QSR, such as pre-approval, surveillance, and for-cause inspections, will survive.  Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, speaking on behalf of MITA, also asked whether FDA’s process to inspect other requirements (e.g., medical device reporting and labeling) will change.  The industry also urged FDA to harmonize not only regulatory expectations, but also the actual procedures for inspections.  Specifically, the industry wants to avoid a “13485 plus type of approach,” where there could be “additional requirements over and above 13485 that are country-unique.”  These concerns were widely echoed across the industry.   </li><li>The industry demands clarity on whether ISO 13485 certification will be required.  Despite incorporating the ISO 13485 standard, FDA has stated that its inspections “will not result in certificates of conformance to ISO 13485 and manufacturers who have ISO 13485 certificates are not exempt from FDA inspections.”  However, the proposed rule did not clarify whether an ISO 13485 certificate will be required or expected.  Committee member Phillips of Siemens Healthineers noted that “topics about whether certification is required, or even expected … [are] something that needs to be clarified going forward.”  This regulatory uncertainty is particularly relevant for small firms that need to determine whether to apply for formal certification from an accredited auditing body.  Further, even if not explicitly required, questions remain about whether there will be preferential regulatory treatment for companies that are formally certified, which could put smaller firms without international presence at an unfair disadvantage.  AdvaMed’s Jamie Wolszon emphasized that the industry is interested in understanding how FDA intends to leverage existing ISO 13485 certifications, including whether there will be any “potential benefit(s)” for firms that are certified.</li></ul><ul><li>Risk management represents a significant change for small companies not previously subject to the ISO 13485 standard.  Harmonizing FDA regulations with the ISO 13485 standard means implementing risk management processes throughout the total product life-cycle.  Although FDA denies that the harmonization amounts to a policy shift, Melissa Torres, Associate Director for International Affairs at the Center for Devices and Radiological Health (CDRH), acknowledged during the meeting that compared to the current Part 820, ISO 13485 “has greater integration of risk management activities and stronger ties to ISO 14971, the risk management standard for medical devices.”  Committee member Scott Sardeson pointed out that the proposed change represents “a very big shift in mindset” for smaller companies that are not currently subject to the ISO 13485 standard and may not be aware of uncodified expectations from FDA.  These concerns add to the case for a longer transition period.</li></ul>The proposed rule may have a significant impact on device manufacturers, especially those not in compliance with the current ISO 13485 standard.  If the one-year proposed implementation timeline is not changed, device manufacturers will face a tight schedule to be in compliance with the new rule.  It is highly recommended that all device manufacturers, especially those without an international presence, review the proposed rule and identify any possible issues with compliance in order to address their challenges head-on.Comments on the proposed rule can be submitted in the Federal Register (<a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">Docket No. FDA-2021-N-0507</a>) until May 24, 2022.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

QMSR: Welcomed by the Industry, but Lacking in Practicality

On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Med

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.The U.S. Food and Drug Administration (FDA) issued the much-anticipated <a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">proposed rule</a> “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820) with the international standard specific for medical device quality management systems set by the International Organization for Standardization, ISO 13485:2016.  QSR has been the core regulation for device manufacturing in the United States since its implementation over 20 years ago.  Medical device establishments have come to have an increasingly international presence, necessitating significant efforts to comply with different requirements.  In order to reduce compliance costs for industry and harmonize domestic and international requirements, FDA first signaled its <a target="_blank" href="https://www.fda.gov/media/123488/download">intent</a> to align its QSR with the ISO 13485:2016 in December 2018, and estimated that a proposed rule would be issued in fall 2019.  After delays likely caused by FDA’s shift in priorities to focus on the COVID-19 response, the agency finally published the proposed rule last month.  The long-awaited and long-delayed proposed rule, if finalized, will rename 21 CFR Part 820 as “Quality Management System Regulation” (QMSR), and will harmonize the U.S. good manufacturing practices with international standards.  The proposal projects to save medical device establishments hundreds of millions of dollars in compliance costs. Many expected that FDA would rewrite QSR in order to align the U.S. regulatory framework with the ISO standard.  To the surprise of many, FDA performed a gap analysis and now proposes to incorporate ISO 13485 by reference rather than re-writing the regulation in its entirety.  ISO 13485 was first introduced in 1996, around the same time when FDA significantly revised Part 820, establishing the current QS regulation.  ISO 13485 went through many revisions since its first issuance, and its most current version has become more closely aligned with the requirements in part 820.  Notably, the 2016 updates to ISO 13485 included several requirements mandated by FDA under its QSR, such as document control and records management, particularly as both relate to protecting confidential information.  This alignment, as well as the agency’s commitment to global regulatory harmonization of medical device regulatory processes, prompted FDA to further explore incorporating the Quality Management System (QMS) requirements of ISO 13485:2016 into Part 820.  However, this “incorporation by reference” approach only applies to the current 2016 version of ISO 13485 and “[a]ny future revisions to this standard would need to be evaluated” before being incorporated.  As before, the proposed rule will only apply to finished devices, although FDA reiterates that it has the legal authority to apply the quality system requirements to manufacturers of components or parts of finished devices when needed.  The proposed QMSR, a nine-page document, is a “gap regulation” that is intended to be read in conjunction with ISO 13485.  Specifically, the proposed rule addresses FDA-specific requirements by adding necessary requirements and definitions that are absent from ISO 13485 and removing redundant or inconsistent regulations from Part 820.  For example, the proposed rule removed the term “device master record” (DMR) because (1) the concept is covered by ISO 13485’s Clause 4.2.3 on medical device files (MDF) and (2) under the QSR, the DMR is part of the design history file, which is inconsistent with the ISO standard.  Below are some key sections of the new proposed rule.Inspection.The proposed rule does not impact FDA’s authority to conduct inspections under section 704 of the Food Drug and Cosmetic Act (“FD&C Act”) (21 U.S.C. § 374).  However, FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the proposed Part 820 as finalized.  Similar to the current QSIT inspection approach, these inspections would involve the collection of information to support observations noted during the inspection and included on FDA Form 483, as appropriate and necessary.  FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, nor is FDA developing a certification program for ISO 13485 or the revised Part 820.  In addition, manufacturers with a certificate of conformance to ISO 13485 are not exempt from FDA inspections.  Firms will need to participate in the Medical Device Single Audit Program (MDSAP) to avoid routine FDA inspections.Supplementary Provisions.  To fill the gap with ISO 13485, the proposed rule seeks to add (1) control of records (proposed section 820.35) and (2) device labeling and packaging controls (proposed section 820.45) to ensure consistency and alignment with other requirements in the FD&C Act and its implementing regulations.  For control of records, the agency plans to add the following requirements: <ul style="text-align: left;"><li>First, signature and date requirements will be required for records subject to Clause 4.2.5 of ISO 13485 (Control of Records).  </li><li>Second, information required by Part 803 (Medical Device Reporting) must be captured on certain records of complaints and servicing activities.  </li><li>Third, firms need to document in their records the Unique Device Identification (UDI) for each medical device or batch of medical devices in accordance with Part 830.  </li><li>Fourth, FDA proposes to retain the clarification from current Part 820 (section 820.180) about confidentiality of records FDA receives to remind firms that FDA protects such records in accordance with Part 20.</li></ul>For device labeling and packaging, ISO 13485 only states that “defined operations for labeling and packaging shall be implemented” without specifically addressing the inspection of labeling by the manufacturer.  Given that many device recalls are related to labeling and packaging, FDA proposes to supplement the ISO standard by retaining requirements from the current Part 820 (i.e., Subpart K).  If finalized, regulated industry must meet the requirements in ISO 13485 7.5.1 (Control of Production and Service) and the proposed section 820.45.Table 1—High-Level Summary of 21 CFR Part 820 Proposed Rule Differences and Additions<table style="text-align: left;" border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Current part 820 </td><td width="229" valign="top" style="width: undefined%; height: auto;">ISO 13485 requirements </td><td valign="top">Proposed rule</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart D—Document Controls</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 4. Quality Management System</td><td valign="top">Differences addressed in 820.35</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart M—Records</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 4. Quality Management System</td><td valign="top">Differences addressed in 820.35</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart K—Labeling and Packaging Control</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 7. Product Realization</td><td valign="top">Differences addressed in 820.45</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart N—Servicing</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 7. Product Realization</td><td valign="top">Differences addressed in 820.35</td></tr></tbody></table>Risk Management.  Compared to the current QSR, which only explicitly addresses risk management activities in relation to design validation, the ISO standard has a greater emphasis on risk management activities and risk-based decision-making throughout the quality management system (QMS) processes.  Risk management for device manufacturers is the essential systematic practice of identifying, analyzing, evaluating, controlling, and monitoring risk throughout the product lifecycle to ensure that the devices they manufacture are safe and effective.  FDA expects the explicit integration of risk management throughout the clauses of ISO 13485 will send a clear message to manufacturers that it is necessary to “integrate risk management activities throughout their QMS and across the total product lifecycle.”On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting.  While most industry stakeholders embraced the agency’s proposal, some have complained that the implementation period is too quick, saying that two years, rather than one, is a more appropriate timeframe.  Stay tuned for more detailed coverage about industry concerns in our next blog.Comments on the proposed rule can be submitted in the Federal Register (<a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">Docket No. FDA-2021-N-0507</a>) until May 24, 2022, and the proposed rule is expected to be effective one year after finalization.<div style="position: absolute;left: -10000px;top: 0px;width: 1px;height: 1px;overflow-x: hidden;overflow-y: hidden;text-align: left;" id="_mcePaste"> <p style="background-image: initial;background-position-x: initial;background-position-y: initial;background-size: initial;background-repeat-x: initial;background-repeat-y: initial;background-attachment: initial;background-origin: initial;background-clip: initial;background-color: white;vertical-align: baseline;" class="MsoNormal"> </div>

Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.
The U.S. Food and Drug Administration (FDA) 

Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016

Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets.Digital Transformation in the Life Sciences<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt05435bfbc3932ff8/6273179623c6cf2a1c3af5cf/mofolifesciences-digital-transformation-life-sciences-themes.jpg?format=auto&quality=60" width="650" height="366" type="asset" sys-style-type="download"> The Digital Health sector had a record-breaking year across the board, with investment and M&A at an all-time high and funding for digital therapeutics and mental health tech more than doubled in the last year. Discussion topics included:<ul><li>Best practices for digital health partnerships <ul><li>How to attract the right partners whether you are a startup or a more established digital health company</li><li>Defining your value proposition</li><li>How to partner with payors and other research organizations</li></ul></li><li>Keeping up momentum <ul><li>Access and consumer adoption</li><li>Focusing on personalization</li><li>Reimbursement challenges</li><li>Working with providers</li></ul></li></ul>View the recording <a href="https://www.youtube.com/watch?v=vOMifzAICH8&t=2s" target="_blank">here</a>. Future of Drug Discovery and Diagnostics<img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blta22f4b1dbaf8de84/627317964886af2aa2be10fa/mofolifesciences-future-drug-discovery-diagnostics.jpg?format=auto&quality=60" type="asset" sys-style-type="download"> The life sciences industry has experienced tremendous change over the last decade and innovation is moving at a rapid rate, fueled not only by new technologies, but also by strategic collaborations to advance next-gen therapeutics and diagnostics in ways we have not seen before. Discussion topics included:<ul><li>How companies are sourcing deals to expand R&D and product pipelines</li><li>The role of food to influence drug discovery and diagnostics and produce more positive outcomes for patients</li><li>How companies are assessing new technologies to treat disease and the tools of the    future that will lead to effective treatments and diagnostics</li><li>Challenges for startups in drug discovery, including financing and finding the right      talent in a competitive market</li></ul>View the recording <a href="https://www.youtube.com/watch?v=mtLiRhsW3_w&t=4s" target="_blank">here</a>.

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MoForum Recap: Transformation Across the Industry

2022 Life Sciences MOFORUM Starts This Week

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Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and