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

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

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

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

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

In follow-up to our colleagues recent <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html">post</a> about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”) Software Draft <a target="_blank" href="https://www.fda.gov/media/109618/download">Guidance</a> (together the “CDS Draft Guidance”) and the MDR. While still in draft form, we note that FDA has signaled its intent to finalize the CDS Draft Guidance in 2021.<h4>Statutory Framework</h4>Under the current CDS Draft Guidance, FDA first bases its approach to CDS on criteria set forth in the 21st Century Cures Act (the “Cures Act”). Excluded from the definition of a “device” under the Cures Act are software functions that met all four of the following criteria:(1) not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern signal from a signal acquisition system;(2) intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);(3) not intended for the purpose of supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and(4) intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.Notably, these criteria do not include software functions intended for a patient or caregiver; rather, these criteria apply only to those software functions for “health care professionals.” Accordingly, software device manufacturers must analyze all software functions utilized by patients and caregivers carefully using the CDS Draft Guidance to determine whether FDA will either exercise its oversight focus, requiring the software to receive FDA approval as a device, or its enforcement discretion.  <h4>IMDRF Framework</h4>FDA’s CDS Draft Guidance also relies on the International Medical Device Regulators Forum (“IMDRF”) Framework for Software as a Medical Device (“SaMD”) in approaching its interpretation of the criteria from the statue that would exclude a software from the definition of a medical device. The MDR also utilized this IMDRF framework for SaMD. IMDRF focuses on two factors, which are critical to the analysis of SaMD: (1) whether the user uses the information provided by a SaMD to treat or diagnose, to drive clinical management, or to inform clinical management; and (2) whether the patient’s healthcare situation or condition is critical, serious, or non-serious.The CDS Draft Guidance utilizes the IMDRF framework, and includes a variation of the classification used under Rule 11 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>, to similarly categorize different types of SaMD.<table border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="156" rowspan="2" style="width: undefined%; height: auto;">State of healthcare situation or condition</td><td width="468" colspan="3" style="width: undefined%; height: auto;">Significance of information provided by SaMD tohealthcare decision</td></tr><tr><td width="156" style="width: undefined%; height: auto;">Treat ordiagnose</td><td width="156" style="width: undefined%; height: auto;">Drive clinical management</td><td width="156" style="width: undefined%; height: auto;">Inform clinicalmanagement</td></tr><tr><td width="156" valign="top" style="width: undefined%; height: auto;">Critical</td><td width="156" valign="top" style="width: undefined%; height: auto;">IV</td><td width="156" valign="top" style="width: undefined%; height: auto;">III</td><td width="156" valign="top" style="width: undefined%; height: auto;">II</td></tr><tr><td width="156" valign="top" style="width: undefined%; height: auto;">Serious</td><td width="156" valign="top" style="width: undefined%; height: auto;">III</td><td width="156" valign="top" style="width: undefined%; height: auto;">II</td><td width="156" valign="top" style="width: undefined%; height: auto;">I</td></tr><tr><td width="156" valign="top" style="width: undefined%; height: auto;">Non-serious</td><td width="156" valign="top" style="width: undefined%; height: auto;">II</td><td width="156" valign="top" style="width: undefined%; height: auto;">I</td><td width="156" valign="top" style="width: undefined%; height: auto;">I</td></tr></tbody></table> FDA uses the risk-categorizations described above to apply a risk-based policy to its regulation of Device CDS functions.<h4>Other Components of the CDS Draft Guidance</h4>In addition to the above framework from IMDRF, the CDS Draft Guidance also focuses on whether the intended user is a healthcare provider or a patient or caregiver and whether the user can independently review the basis for the recommendation from the software.  This focus on user-type and independent review, rooted in the Cures Act language, is a departure from the IMDRF (and the MDR’s) framework, which focuses more upon the intended use of the software and the medical conditions the software covers. As you can see in the table below, FDA has a demonstrated interest in those software functions where the intended user is a patient or caregiver, particularly when the device is informing clinical management for serious or critical healthcare situations or conditions. Similarly, when the intended user is a healthcare provider, FDA does not consider the software to be a device so long as the healthcare provider can independently review the basis for the recommendation.Combining the IMDRF Framework with FDA’s focus on the user-type and whether the user can independently review the basis for the recommendation, results in the following table:<table border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="249" colspan="2" valign="top" style="width: undefined%; height: auto;"> </td><td width="125" valign="top" style="width: undefined%; height: auto;">Intended User is HCP</td><td width="234" valign="top" style="width: undefined%; height: auto;">Intended User is Patient or Caregiver</td></tr><tr><td width="125" valign="top" style="width: undefined%; height: auto;">IMDRF Risk Categorization</td><td width="125" valign="top" style="width: undefined%; height: auto;">Can the User Independently Review the Basis?</td><td width="125" valign="top" style="width: undefined%; height: auto;">FDA Regulation</td><td width="234" valign="top" style="width: undefined%; height: auto;">FDA Regulation</td></tr><tr><td width="125" rowspan="2" valign="top" style="width: undefined%; height: auto;">InformxCritical</td><td width="125" style="width: undefined%; height: auto;">Yes</td><td width="125" style="width: undefined%; height: auto;">Not a Device</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" style="width: undefined%; height: auto;">No</td><td width="125" style="width: undefined%; height: auto;">Oversight Focus</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" rowspan="2" valign="top" style="width: undefined%; height: auto;">InformxSerious</td><td width="125" style="width: undefined%; height: auto;">Yes</td><td width="125" style="width: undefined%; height: auto;">Not a Device</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" style="width: undefined%; height: auto;">No</td><td width="125" style="width: undefined%; height: auto;">Oversight Focus</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr><tr><td width="125" rowspan="2" valign="top" style="width: undefined%; height: auto;">InformxNon-Serious</td><td width="125" style="width: undefined%; height: auto;">Yes</td><td width="125" style="width: undefined%; height: auto;">Not a Device</td><td width="234" style="width: undefined%; height: auto;">Enforcement Discretion</td></tr><tr><td width="125" style="width: undefined%; height: auto;">No</td><td width="125" style="width: undefined%; height: auto;">Enforcement Discretion</td><td width="234" style="width: undefined%; height: auto;">Oversight Focus</td></tr></tbody></table> <h4>Examples</h4>The CDS Draft Guidance provides a number of examples where FDA works through its framework. These examples walk through the IMDRF framework while considering the intended user and whether the user can independently review the recommendation from the SaMD.Non-Device CDSFDA considers the following software to not be a device: software that compares patient signs, symptoms, or results with available practice guidelines (institutions-based or academic/clinical society-based) to recommend condition-specific diagnostic tests, investigations, or therapy to healthcare providers. In this example, the software uses practice guidelines as the basis for the recommendation and provides such guidelines to the healthcare provider to review, such that the health care provider does not rely primarily on the software’s recommendation.Enforcement DiscretionFDA plans to utilize its enforcement discretion on software that assist a patient in identifying an over-the-counter cold or allergy medication to consider purchasing based on symptoms. In this example, the software would include appropriate warnings about products with overlapping ingredients. This software is device CDS because it is intended for a patient; however, FDA does not intend to enforce compliance because the software is intended to provide options to patients for the treatment of a non-serious situation or condition and because the patient can independently review the basis for the software’s recommendations.Oversight FocusFDA plans to focus its regulatory oversight on device CDS functions intended for patients, where the software is informing clinical management of serious or critical conditions. For example, FDA intends to regulate the following as device CDS: a software function that recommends when the parent or caregiver of pediatric patients with cystic fibrosis should take a child to the emergency room by aggregating information based on patient-specific symptoms and care guidelines. This software is device CDS because a caregiver uses the software and the software informs clinical management for a critical situation or condition, particularly because of the fragility of the target population.   <h4>Conclusion</h4>Recognizing that companies with global offerings face a complexity of issues, companies should seek to leverage similarities amongst the regulatory classification of SaMD and CDS. However, companies should simultaneously be acutely attuned to the critical differences in how those frameworks are applied by the applicable regulatory bodies. There is a need for attention to these issues, particularly with the upcoming finalization of the CDS guidance in FY2021 by FDA and the MDR coming into effect on May 26, 2021.

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

In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of t

The preceding articles of this <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">series </a>laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an overall deeper level of regulation in areas already regulated before.  This episode will put the spotlight on a feature introduced to the European market of medical devices for the first time: the Unique Device Identification (“UDI”) system, also referred to as the bar-code system for medical devices.<h4>INTRODUCTION</h4>Following the lifecycle approach of the MDR, the identification system aims to enhance the effectiveness of the post-market safety-related activities. The system brings about two key obligations: device labeling and data submission requirements.  If this does not sound at all novel, it might be for other medical device markets, such as the U.S., that have had similar rules in place for quite some time.  The UDI is obtained through officially designated entities, some of which are entrusted by both EU and U.S. authorities.  The data submissions will have to be made to the European Databank on Medical Devices (“<a href="https://eudamed.eu/" target="_blank">EUDAMED</a>”), which is in the process of being set up. Submissions of UDI data to EUDAMED will be mandatory beginning November 26, 2022. However, providers of medical device software (“MDSW”) can start the process of obtaining a UDI immediately.<h4>1. UDI FORMATS</h4>The MDR requires a medical device to be labelled with a certain UDI, which allows for a clear and unambiguous identification of specific medical devices and facilitates their traceability on the market. What is visible, is called the “UDI-carrier,” which can either be an automatic identification and data capture (“AIDC”) (i.e., bar codes, smart cards, biometrics, etc.) or a human-readable interpretation (“HRI”) (a series of numeric or alphanumeric characters). All of the issuing entities, currently <a href="https://ec.europa.eu/docsroom/documents/38582?locale=en" target="_blank">GS1</a>, <a href="https://ec.europa.eu/docsroom/documents/38564?locale=en" target="_blank">HIBCC</a>, <a href="https://ec.europa.eu/docsroom/documents/38566?locale=en" target="_blank">ICCBBA</a>, and <a href="https://ec.europa.eu/docsroom/documents/38581?locale=en" target="_blank">IFA GmbH</a>, have their own algorithm to create UDIs. The format is based on guidelines (<a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_1_budi_rules_ie_en.pdf" target="_blank">here</a>) but will be specific to the issuing entity.  An example of a human-readable UDI assigned by IFA GmbH could be “(9N)1101234568(S)ABC123.”According to Article 27 of the MDR, the UDI comprises of a Device Identifier (“UDI-DI”), which is specific to a manufacturer and a device, and the Production Identifier (“UDI-PI”), which identifies the unit of device production.The UDI-DI is linked to a so-called Basic UDI-DI that connects devices with the same intended purpose, risk class, and essential design and manufacturing characteristics, identifying a certain group of devices. The Basic UDI-DI itself will not be placed on the product but has to be provided to EUDAMED.<h4>2. UDI FOR MDSW</h4>Annex VI Part C Point 6.5 of the MDR addresses the UDI assignment on MDSW specifically. Some guidance on the <a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2018_5_software_en.pdf" target="_blank">UDI assignment to MDSW</a> provided by the Medical Device Coordination Group is provided <a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2018_5_software_en.pdf" target="_blank">here</a>, according to which UDI-DI shall be assigned to stand-alone MDSW (available on its own and software that constitutes a device in itself) at the system level of such MDSW. If MDSW is sold on a physical medium, every level of packaging needs to display UDI in AIDC format and HRI format. Software comprising a user interface must display the UDI easily accessible in plain-text format, while software without a user interface needs to be able to transfer the UDI by API.Upon substantial changes to the MDSW, a new UDI-DI is required (Annex VI Part C Point 6.5.2 of the MDR). Guidance on changes can be found <a href="https://ec.europa.eu/docsroom/documents/40322" target="_blank">here</a>. Such new UDI-DI requirements are also triggered upon a change to Basic UDI-DI that impacts the original performance, safety, or the interpretation of data or to the name or trade name, version or model number, critical warnings or contraindications, or user interface language. Minor software revisions, such as bug fixes, usability enhancements that are not for safety purposes, security patches, or operating efficiency, shall require a new UDI-PI and not a new UDI‑DI.<h4>3. CONCLUDING REMARKS</h4>With the introduction of the UDI system, the MDR steps up the post-market transparency and levels with what seems to have become an international regulatory standard. For providers of MDSW, this means to plan for additional steps before placing their products on the market. From a regulatory perspective, it is necessary to obtain a UDI and provide data to EUDAMED, while practically a labeling concept has to be developed.Against this background, manufacturers of medical devices should bear in mind the timeline regarding the obligation of UDI assignment, which depends on the device class. High-risk devices in Class III start on May 26, 2021, followed by Class IIa and IIb devices, which are due on May 26, 2023. The low-risk devices in Class I are due on May 26, 2025. Links to previous articles in the 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">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 1 OF 6)</a><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 2 OF 6)</a><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 3 OF 6)</a><a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force-Part-4-of-6.html">SOFTWARE AS A MEDICAL DEVICE IN EUROPE – NEW REGULATORY REGIME ABOUT TO ENTER INTO FORCE – (PART 4 OF 6)</a>

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Counsel

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

Stephan Kreß

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

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

Robert Grohmann

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

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Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)

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

mofolifesciences-eu

The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 (“MDR”) leads to a broader coverage of medical devices and an o

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 5 of 6)

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html">part 2</a>) and the implications of the new risk classification regime (in <a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Europe-New-Reg-Regime-to-Enter-into-Force-Part-3.html" target="_blank">part 3</a>), in this part 4 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 on Software as a Medical Device in Europe</a>, we will now explore key changes to the quality assurance and documentation requirements for stand-alone medical device software (“MDSW”) under the new <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN" target="_blank">EU Medical Device Regulation 2017/745</a> (“MDR”).<h4>INTRODUCTION: A NEW LIFE CYCLE-FOCUSED APPROACH</h4>While the current <a target="_blank" href="https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF">EU Medical Device Directive 93/42/EEC</a> (as amended by Directive 2007/47/EC – “MDD”) primarily focusses on the pre-approval stage of a medical device and how the manufacturer can obtain the CE marking, the MDR deploys a product life cycle-focused approach, aiming to establish responsibilities of medical device companies throughout the life cycle of the product. While not all requirements are new, to ensure conformity of the MDSW with the MDR, detailed and partly enhanced requirements concerning quality management, risk management, clinical evaluation, and technical documentation must be complied with post-market for the time the MDSW is in service.<h4>1. QUALITIY MANAGEMENTS SYSTEMS</h4>Article 10(9) of the MDR has extended the scope of the Quality Management Systems (“QMS”) required to be in place for MDSW. Key changes include:<ul><li>Document Control. More so than the MDD, the MDR requires continuous alignment and updating of the documentation with regard to available data, records, and post-market surveillance (see, e.g., Article 83(3) and Annex IX, I 2.2 (c) MDR). This will require the manufacturer to maintain a seamless system of data and information, ensuring that documents are generated and updated in a coordinated and coherent way throughout the organization.</li></ul><ul><li>Post-Market Surveillance: According to Articles 83 and 84 of the MDR, for each device, the manufacturer shall implement, maintain, document, and update a post-market surveillance system that shall be suited to actively and systematically gather, record, and analyze relevant data on the quality, performance, and safety of a device throughout its entire lifetime, and to draw the necessary conclusions and take preventive and corrective actions. This includes continuously updating the risk assessment and technical files of the MDSW. The post-market surveillance system shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III.</li></ul><ul><li>Periodic Safety Update Report. Manufacturers of class IIa, class IIb, and class III devices have to prepare a Periodic Safety Update Report (“PSUR”) for each device (or category or group of devices, as applicable), summarizing the results and conclusions based on the post-market surveillance data and any preventive and corrective actions taken (Article 86 of the MDR). For class IIb and class III devices, the PSUR shall be updated at least annually.</li></ul><ul><li>General Safety and Performance Requirements. The “essential requirements” under the MDD have been replaced by the “General Safety and Performance Requirements” (GSPR). GSPR for software are included in the new Section 17.2 of Annex I. According to this provision, software shall be developed and manufactured in accordance with the state of the art, taking into account the principles of development life cycle and risk management, including information security, verification, and validation. According to Article 8 of the MDR, compliance with so-called harmonized standards creates the presumption of conformity with the GSPR of Annex I. While there are over 250 harmonized standards for the MDD, there are currently no relevant harmonized standards for the MDR. Manufacturers will need to adhere to existing relevant standards (e.g., IEC 62304:2006 – Medical device software – Software life-cycle processes) but should pay close attention to any upcoming harmonized standards.</li></ul><ul><li>Supply Chain. Under the MDR, required scrutiny with regard to suppliers and outsourced processes is increased. The documentation requirements pertaining to the supply chain are stipulated in Article 25 of the MDR. While manufacturers already have responsibilities for stand-alone MDSW under the MDD, the MDR sets out specific new requirements for other economic operators like authorized representatives (Article 11 and 12), importers (Article 13), distributors (Article 14), and sterilizers and packaging (Article 22) in this regard. Manufactures have to ensure that everyone in the supply chain of its MDSW who is considered an “economic operator” under the MDR understands the key changes to quality management and has a plan in place for compliance with their specific responsibility under the MDR.</li></ul><ul><li>Document Retention. The period during which manufacturers have to store technical documentation has extended from five to 10 years after the last device has been placed on the market (Annex IX Section 7 MDR). For implants it is, and has been, 15 years.</li></ul><ul><li>Incident Reporting. The deadline for reporting serious incidents involving medical devices made available on the EU market to the competent authorities has been shortened from 30 days (for incidents not amounting to serious public health threats, death, or serious deterioration in health) under the MDD (MEDDEV 2 12-1, Section 5.1.7) to 15 days under the MDR (Article 87(3) MDR).</li></ul>Manufacturers of MDSW find a framework for QMS in <a href="https://www.iso.org/standard/59752.html" target="_blank">ISO 13485</a>, which provides a safe and easy way to prove conformity. While certification under this already-established standard will be the main path to establish QMS compliance under the MDR, manufacturers of MDSW with an existing QMS must ensure that the new and amended requirements under the MDR are covered by their existing QMS. Manufacturers should note that all QMS requirements must be met as of May 26, 2021, even if certain medical devices offered by them fall under a transition period.<h4>2. CLINICAL EVALUATIONS</h4>All manufacturers of medical devices are obligated to conduct a clinical evaluation. The MDR provides for requirements that are more precise as compared to the MDD regime, particularly regarding the post-market obligations. Clinical evaluation means a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. A sufficient amount and quality of clinical data have to underpin scientific validity, technical, and clinical performance. The Post-Market Clinical Follow-up (“PMCF”) that already existed under the MDD is now specified in more detail in Annex XIV Part B. A newly introduced requirement is the PMCF evaluation report, which shall provide analyzed findings of the PMCF. A template for the PMCF evaluation report can be found <a href="https://ec.europa.eu/docsroom/documents/40906" target="_blank">here</a>. The Medical Device Coordination Group provides guidance on relevant aspects regarding MDSW, focused on international standards (<a href="https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_1_guidance_clinic_eva_md_software_en.pdf" target="_blank">MDCG 2020-1</a>). The MDCG 2020-1 identifies three key components that need to be taken into account when compiling clinical evidence for every MDSW:<ul><li>Scientific Validity (Valid Clinical Association). There needs to be a valid scientific association between the output of the MDSW (calculations, recommendations, etc.) based on the input and algorithms selected on the one hand and the targeted physiological state or clinical condition on the other hand. For example, if the MDSW is designed to detect a certain disease by analyzing abnormal measurement values, there needs to be a valid clinical association between the analyzed measurement values and the disease in question. The association must be well founded or clinically accepted. This component seeks to establish that the use of the MDSW is based on sound scientific principles.</li></ul><ul><li>Technical Performance (Analytical Performance). The MDSW must be able to accurately, reliably, and precisely generate the intended output from the input data. Evidence of this can be generated through verification and validation activities.</li></ul><ul><li>Clinical Performance. For those features of the MDSW that claim a specific clinical benefit, the manufacturer must demonstrate that the MDSW can achieve clinically relevant output in accordance with the intended purpose. For the validation of an MDSW’s clinical performance, the MDSW must have been tested (i) for the intended use(s) on the target population(s), (ii) under the use condition(s) and operating and use environment(s), and (iii) with all intended user group(s).</li></ul><h4>3. TECHNICAL DOCUMENTATION</h4>Requirements for the technical documentation of the MDSW are now explicitly addressed in Article 10(4) and Annexes II and III of the MDR. With regard to the technical documentation, the MDR brings about increased requirements, along with more details on how technical documentation has to be carried out and structured. The technical documentation has to be drawn up in a “clear, organized, readily searchable and unambiguous manner.” Annexes II and III of the regulation list elements to be contained, which in the pre-market phase include (i) information on device description and specification, including variants and accessories; (ii) information to be supplied by the manufacturer; (iii) design and manufacturing information; (iv) general safety and performance requirements; (v) risk-benefit analysis and risk management; and (vi) product verification and validation. As outlined above, any MDSW that is available on the market must be covered by a post-market surveillance plan according to Article 84, a post-market surveillance report according to Article 85, and a periodic safety update report according to Article 86 (PSUR) if class IIa or higher. The newly introduced PMCF evaluation report shall form part of the PSUR.<h4>CONCLUDING REMARKS</h4>The new life cycle-oriented approach under the MDR requires manufacturers of stand-alone MDSW to reassess their current quality management and documentation strategy and to set up a comprehensive process that encompasses, among other things, QMS and technical documentation post-market surveillance procedures. As it might take months to have a complying QMS in place, suppliers of MDSW need to be working on this now if they have not already done so.

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 4 of 6)

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to stakeholder feedback. It is now one month later, and the FDA has yet to implement any steps outlined in its action plan, all the while approving more and more AI products. This post discusses the progress the FDA has made thus far for regulating AI/ML-based SaMDs and the concerns that remain.<h4>FDA’s Progress for Regulatory Oversight</h4>Artificial intelligence is growing rapidly in the field of healthcare. The <a target="_blank" href="https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device">FDA has acknowledged</a> its importance and the impact it has on health care, but has not been able to keep up with manufacturers. In April 2019, the FDA published “<a target="_blank" href="https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf">Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback</a>,” describing for the first time, clearly, the FDA’s potential approach to premarket review of AI/ML SaMDs. The potential approach involved a “Predetermined Change Control Plan” for premarket submissions including “SaMD Pre‑Specifications” (SPS) and an “Algorithm Change Protocol” (ACP) to account for the iterative nature of AI/ML-based SaMDs.In February 2020, the FDA announced a marketing authorization via the De Novo pathway for the <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user">first cardiac ultrasonic software that uses AI to guide users</a>. The manufacturer used a Predetermined Change Control Plan in its application to obtain authorization.In the same month, the FDA held a public workshop on the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The FDA and the public stakeholders discussed best practices for validation of AI‑automated radiological imaging software and image acquisition devices.In September 2020, FDA launched the <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-launches-digital-health-center-excellence">Digital Health Center of Excellence</a> within the Center for Devices and Radiological Health. According to the FDA, the focus of the Digital Health Center of Excellence is “helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimaging digital health device oversight.”In January 2021, the FDA published “<a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan">Artificial Intelligence/Machine Learning (AI/ML)‑Based Software as a Medical Device (SaMD) Action Plan</a>,” outlining the FDA’s plans for progressing its regulatory oversight. The Action Plan identified five areas for the FDA focus: <ol><li>Tailored regulatory framework for AI/ML-based SaMDs; </li><li>Good machine learning practices (GMLPs); </li><li>Patient-centered approach incorporating transparency to users; </li><li>Regulatory science methods related to algorithm bias and robustness; and </li><li>Real-world performance (RWP).  </li></ol>The FDA stated that it will update its regulatory framework and publish a draft guidance in 2021, actively engage in efforts to harmonize GMLPs, hold public workshops on device labeling for transparency to users, develop methodology for evaluating and improving machine learning algorithms (including identifying and eliminating bias), and develop a framework for gathering and validating RWP. Although the AI/ML Action Plan is recent, the FDA has not yet taken any steps to implement any of these focus areas for policy development or clarification.<h4>The FDA’s Approval of AI/ML-Based SaMDs</h4>Since 2012, the FDA has approved over 160 medical AI/ML-based SaMDs, the majority being in 2019 and 2020. Some <a target="_blank" href="https://www.statnews.com/2021/02/03/fda-artificial-intelligence-clearance-products/">reports</a> have found, upon investigation, that the requirements the FDA has imposed on device submission have been inconsistent. For example, some submission sponsors disclosed the amount of patient data used to validate the performance of their devices while others did not. And, according to one investigative <a target="_blank" href="https://www.statnews.com/2021/02/03/fda-clearances-artificial-intelligence-data/">report</a>, when disclosed, the amount of data varied widely from 100 patients on one end of the spectrum to 15,000 patients on the other end. Only a handful of manufacturers reported racial makeup of the study populations and a few provided gender breakdown. This creates uncertainty as to how effective the AI/ML-based SaMDs will perform with respect to algorithmic bias. Additionally, the FDA has not made training and testing data for these approved AI/ML-based SaMDs publicly available, potentially creating a lack of trust in these technologies or, at the very least, making it difficult for purchasers of the SaMDs to make informed decisions based on similar evidence criteria. However, perhaps most importantly, the FDA has yet to figure out how to handle real-world leaning and adaptation within the regulatory framework. Although the FDA clearly aims for increased regulation and monitoring of AI/ML-based SaMDs, it has not provided a specific plan for any of the five focus areas identified in its AI/ML Action Plan. The FDA may need to act much quicker in developing consistent standards as the number of AI/ML-based SaMDs submissions to the FDA continue to increase (from two products in 2012 to 70 products in 2019). The FDA should address stakeholder concerns of data and approval process inconsistencies, lack of well-established standards, transparency, labeling challenges, trustworthiness, algorithmic biases, and RWP. ConclusionThe FDA is slowly taking steps towards its commitment to develop a regulatory framework for AI/ML-based SaMDs. For now, the FDA has not yet provided any consistent standards. Without such widely-applicable guidance, manufacturers should expect a longer application timeline and extensive discussions with the FDA—in effect creating a customized plan for data and evidence generation for each and every AI/ML SaMD. It is unpredictable at this stage what the FDA will require and ask for in these negotiations, although to some extent prior submissions and authorizations serve as a baseline for consideration. As artificial intelligence and machine learning technologies are increasing in availability and applicability, organizations and device sponsors will continue to build their own databases and define their own standards, which the FDA may be strategically waiting for.

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Associate

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

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FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

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U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (S

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In addition, a number of policies implemented in response to COVID-19 are expected to have a positive impact on rare disease drug development going forward. Yet, the lasting nature of these policies, post-pandemic, remains uncertain, creating an opportunity for rare disease drug sponsors to be proactive in engaging with regulatory authorities and the patient community to advocate the retention of these positive policy developments.A quick review of the <a href="https://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm" target="_blank">FDA’s Orphan Drug Designation Database</a> for designations with a 2020 date finds that 476 Orphan Drug Designations (ODDs) were issued by FDA’s Office of Orphan Drug Product Development. This compares to 340 ODDs issued by FDA during 2019. This indicates that both product development and FDA resources remained focused on rare disease products, even during the exceptional strains 2020 brought to both groups. On August 28, 2020, FDA proceeded with the planned public meeting on “<a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-cder-standard-core-sets-clinical-outcome-assessments-and-endpoints-grant-program-0" target="_blank">CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program</a>,” an important milestone in the COA Endpoints Pilot Grant Program where grantees were able to share their development plans for the COA standard core COAs sets and receive feedback from stakeholders. The COA Endpoints Pilot Grant Program launched late in 2019 and is part of FDA’s Patient Focused Drug Development efforts. Three grants were made to enable COA standard core set development in (1) migraine, (2) acute pain in infants and young children, and (3) physical function across a range of chronic conditions. The goal of the COA standard core sets is to establish a minimum list of impacts that matter most to patients, are likely to demonstrate change, and that should be assessed during a clinical trial.Although not purposefully directed at rare disease clinical trials, FDA’s “<a href="https://www.regulations.gov/document/FDA-2020-D-1106-0002" target="_blank">Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators and Institutional Review Boards</a>” released on March 18, 2020, has in fact significantly benefited ongoing and newly initiated rare disease trials. FDA often updated the guidance throughout 2020, in April, May, July, September, and in December, each time addressing new questions and providing further clarity on trials for enrollment, remote visits, remote monitoring, and protocol modifications. Clinical trials for rare disease indications are particularly important to the rare disease patient community since there are approximately 7,000 identified rare diseases and a mere 10% have an FDA-approved treatment or therapy, meaning many patients can only access unapproved treatments through investigational studies. The policy changes made in response to the pandemic may pave the way in the future for decentralized, virtual clinical trials that are expected to significantly benefit rare disease studies where patient enrollment, engagement, and retention are exceptionally challenging. These policies allowed for integrating home health visits and telemedicine, direct-to-patient drug and supply delivery, and collection of data by portable or wearable devices. A November 12, 2020, Tuffs Center for the Study of Drug Development report found that “55% of active ongoing clinical trials have transitioned to remote and virtual execution models since early spring,” indicating that the transition to decentralized trial design is prevalent and may become the norm in coming years.FDA implemented administrative simplifications, such as permitting applicants and sponsors to submit information to the Office of Orphan Drug Product Development through email submissions rather than the recently launched online portal for ODD requests. Congress also assisted in maintaining existing rare disease programs in 2020, authorizing an extension of the <a href="https://www.fda.gov/media/90014/download" target="_blank">Rare Pediatric Disease Priority Review Voucher</a> program in December 2020, that was, as we disused in an <a href="https://lifesciences.mofo.com/topics/Bill-Proposes-Continuation-of-FDA-Rare-Pediatric-Disease-Priority-Review-Vouchers.html" target="_blank">earlier post</a>, at risk of expiring in the midst of the pandemic.FDA’s rare disease focus in 2020 extended to minimizing the impact of COVID-19 circumstances for rare disease patients. For example, FDA quickly realized the increase in demand for hydroxychloroquine as a potential treatment for COVID-19 and established a priority review process for all generic hydroxychloroquine drug applications so that lupus patients could continue to access the drug for its FDA-approved use. FDA also worked with manufacturers of rare disease drugs as part of FDA’s supply chain management efforts in response to COVID-19.Rare disease patients were uniquely impacted during the COVID-19 pandemic, with 74% of the <a href="https://rarediseases.org/wp-content/uploads/2020/05/NRD-2061-RareInsights-CV19-Report_v2-2.pdf" target="_blank">NORD survey</a> respondents reporting a medical appointment had been canceled due to the pandemic, and 29% of respondents reporting loss of a job, with 11% of those job losses also meaning a complete loss of health insurance. We are encouraged that sponsors continue drug development programs, as evidenced by the large number of ODDs in 2020, and that FDA continues to devote resources and attention to programs focused on rare disease drug development. We will monitor these areas in 2021 and remain hopeful that the clinical trial policies put into effect during the pandemic prove to be viable and accessible tools for future rare disease clinical trials.On the patent exclusivity and investment fronts, orphan diseases have increasingly been on the forefront, with focus on drugs and partnering for these indications. This reflects a major shift and a breakaway from the traditional, narrower view of the value and importance of these programs. “Five or 10 years ago the dogma was that these indications would not necessarily warrant full investment, either for clinical development or patent exclusivity,” according to Morrison & Foerster’s partner <a href="https://www.mofo.com/people/catherine-polizzi.html" target="_blank">Dr. Catherine Polizzi</a>, recognized patent law leader with over 25 years in life sciences patent practice. “I thought this was a short-sided view, and that there was tremendous opportunity in rare diseases, not to mention the important attention needed for these patients. Those who previously ignored this have very much changed course.”

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Intellectual versatility combined with incisive, pragmatic counseling and business acumen is the hallmark of Catherine’s practice.
Catherine helps emerging and established companies through the challe

Catherine M. Polizzi Ph.D.

Catherine Polizzi

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Rare Disease: Sustained Progress in Development Regardless of the Pandemic

mofolifesciences-intellectual-property

Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare dis

Rare Disease: Sustained Progress in Development Regardless of the Pandemic

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.

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

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

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

Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is to create a structure for the UK Government to legislate for updates or amendments to our existing laws on human and veterinary medicine, clinical trials, and medical devices. Now that the Brexit transition period has come to an end, the Government views the Act as essential in ensuring that the UK retains its position as a world leader in the life sciences industry and is able to take advantage of innovative medicines and technologies more quickly.During its passage through Parliament, the Act was subject to a number of amendments, including the introduction of: (i) an independent Commissioner for Public Safety, and an overarching objective focused on safeguarding public health; and (ii) public consultations in relation to proposed regulations, and requirements for the Medicines and Healthcare products Regulatory Agency (the MHRA) to lay periodic reports before Parliament. These amendments were made to address concerns in the House of Lords surrounding the wide-reaching powers delegated to the MHRA under the Act.One aspect of the Act that remains largely unchanged, however, is the introduction of new enforcement powers for the MHRA. With these new powers, the MHRA can impose either civil or criminal sanctions for breaches of the Act or any secondary legislation made pursuant to it. These offences can be committed by corporates as well as individuals, including company directors. For more information on the offences themselves and the ways in which the resulting penalties can be defended or avoided, see <a target="_blank" href="https://www.mofo.com/resources/insights/201113-uk-life-sciences-regulation-post-brexit.html">our previous alert</a>.Now that the Act has become law, the MHRA must prepare and publish guidance as to the civil sanctions that can be imposed. In particular, the guidance should provide further information regarding monetary penalties and the MHRA’s power to accept enforcement undertakings in place of criminal conviction or the imposition of a fine.  With the objective of the Act being the safeguard of public health and safety it is, however, likely that financial sanctions will be onerous and tolerance for corporates without robust procedures in place will be low.Although the Act now allows the UK the flexibility to respond quickly to medical advances and developments in medical technology, we note that the UK-EU Trade and Cooperation Agreement does not provide for the mutual recognition of regulatory regimes. It will, therefore, be interesting to see how the UK Government and the MHRA seek to balance a new, robust and evolving regulatory regime with the need to remain commercially viable for multinational pharmaceutical companies, medical devices manufacturers and other affected parties that currently operate in both markets. Stephanie Pong, London Trainee Solicitor, contributed to the drafting of this alert.