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.

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Resources

Editors

230315-new-mofo-life-sciences-logo.jpg

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.

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

Patent Strategy + Prosecution

Patent Prosecution | Patent Firm

Band 1: Intellectual Property: Patent Prosecution, California

Tier 1: Patent Strategy & Management

Recommended: Patent Prosecution

Patent Strategy Firm Of The Year

 Intellectual Property: Patents: Prosecution

Recommended for Patent Prosecution in California and DC Metro Area

Highly Recommended: Patent Prosecution, California

Patent Prosecution, US 

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>

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

Life Sciences: IP/Patent Litigation

Life Sciences

Global: Life Sciences

Asia-Pacific Region: Life Sciences

Healthcare: Life Sciences

China Healthcare and Life Sciences: Foreign Firms

US: Biotechnology Law

Japan: Life Sciences

China: Life Sciences: International Law Firm

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

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

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.

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech Blog

MOFO TECH

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

SOCIALLY AWARE

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

Provides insights and reports on the most current class actions lawsuits and product liability issues that affect consumer-facing companies.

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

Federal Circuit Clarifies Requirements for Prior Art Under Pre-AIA 35 U.S.C. § 102(e)

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

LinkedIN

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is asking for notifications of intent to develop monkeypox diagnostic tests by October 13, 2022. On August 4, 2022, HHS Secretary Becerra declared a <a href="https://www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html" target="_blank">Public Health Emergency</a> acknowledging the ongoing rapid transmission of monkeypox and the necessity of an urgent response. In a public health emergency, FDA requires in vitro diagnostic tests, including laboratory developed tests, to undergo premarket review to ensure the accuracy and reliability of such testing. To speed the availability of these tests, FDA has unique authorities during an emergency to issue emergency use authorizations (“EUAs”) under an expedited review process created by section 564 of the Federal Food, Drug, and Cosmetic Act. On September 7, 2022, Secretary Becerra signed a section <a href="https://www.hhs.gov/about/news/2022/09/07/hhs-secretary-becerra-issues-564-declaration-to-expand-the-availability-of-testing-for-monkeypox.html" target="_blank">564 Declaration</a> allowing FDA to use its EUA authority for in vitro diagnostics to more rapidly expand testing availability.To aid developers in preparing EUA submissions, on September 13th FDA issued a final guidance: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-monkeypox-tests-address-public-health-emergency" target="_blank">Policy for Monkeypox Tests to Address the Public Health Emergency</a>. As noted in the guidance, “FDA intends to prioritize review of EUA requests for high-throughput diagnostic tests, tests with home specimen collection, or rapid all from experienced developers with high manufacturing capacity.” Significantly, FDA requested interested parties send an intent to submit an EUA by October 13, 2022. It should be noted that FDA does not expect EUA requests for certain validated diagnostic LDTs that are developed and performed in a single lab, that uses PCR, and when the only sample type is a lesion swab sample from a potential monkeypox lesion.FDA also issued an EUA template and summary template for molecular diagnostic tests, which are available for download on <a href="https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices">Monkeypox Emergency Use Authorizations for Medical Devices</a>. For general FAQs and regular updates, FDA is maintaining a Frequently Asked Questions page available here: <a href="https://www.fda.gov/medical-devices/monkeypox-and-medical-devices/faqs-testing-monkeypox">FAQs on Testing for Monkeypox</a>.Since issuing the declaration, FDA has issued one emergency use authorization for a <a href="https://www.fda.gov/media/161454/download" target="_blank">multiple target, Real-Time PCR test</a>. This test is joined on the market by the CDC-developed, FDA-cleared non-variola Orthopoxvirus (“NVO”) assay. FDA has further clarified that there are no current shortages of monkeypox tests, test kits, nor reagents, especially the CDC NVO assay.In addition, leadership from FDA’s CDRH Diagnostics Office (OHT7) will now host a weekly virtual town hall for monkeypox test developers beginning September 21, 2022 (12:05 - 1:00 p.m. ET). The webinar, in a similar format to the virtual town hall for COVID-19 test developers, will include announcing updates, addressing previously emailed questions, and answering live questions. Now that the town hall for COVID-19 test developers occurs on a monthly basis, there will be a monthly combined town hall addressing both COVID-19 and monkeypox updates and questions beginning on September 28, 2022 (12:05 - 1:00 p.m. ET). For monkeypox virtual town hall details, please visit the Virtual Town Hall Series - Monkeypox Test Development and Validation.MoFo’s FDA + Healthcare Regulatory and Compliance practice is following these developments closely and assisting developers in the preparation of their notifications and submissions. We look forward to assisting test developers as they respond to this unfolding public health emergency.

bondoc_brigid_blog_150x150.png

bondoc_brigid_common_640x280.jpg

bondoc_brigid_heroretina_2700x1160.jpg

bondoc_brigid_mobileretina_750x1040.jpg

bondoc_brigid_social_600x600.jpg

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

220923-content.jpg

New Opportunities for Test Developers: Monkeypox Diagnostics

220923-content

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. 

New Opportunities for Test Developers: Monkeypox Diagnostics

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a <a href="https://www.govinfo.gov/content/pkg/FR-2022-07-29/pdf/2022-16299.pdf">Notice</a> in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. The Notice reminds applicants of the duties of disclosure and “reasonable inquiry” for proceedings before the USPTO or Patent Trial and Appeal Board (PTAB). It is an outgrowth of President Biden’s 2021 <a href="https://lifesciences.mofo.com/topics/biden-administration-executive-order-on-promoting-competition-in-the-american-economy-drug-pricing-and-healthcare-industry-initiatives">Executive Order on Promoting Competition in the American Economy</a>, in which the acting U.S. Food and Drug Administration (FDA) Commissioner <a href="https://www.uspto.gov/sites/default/files/documents/EO14036-FDALettertoPTO.pdf">wrote to</a> the acting USPTO Director highlighting numerous areas in which the USPTO and FDA could work together to reduce drug costs. In particular, the Notice emphasized the duty to disclose material information and statements from communications with the FDA. Companies that make submissions to both the USPTO and the FDA, such as pharmaceutical companies and medical device manufacturers, should pay special attention to the Notice.Disclosing Information Received from the FDAAs part of an abbreviated new drug application (ANDA), generics can provide arguments that patents covering the innovator drug are invalid in a Paragraph IV certification. The Paragraph IV certifications are then communicated to the patent owners by the FDA.The duty of “reasonable inquiry” under 37 C.F.R 11.18(b)(2) requires that each party submitting a paper to the USPTO perform an inquiry that is reasonable under the circumstances to confirm the accuracy and consistency of statements made therein, but does not detail what is involved in a reasonable inquiry.The Notice now expressly clarifies that the duty of reasonable inquiry includes reviewing paragraph IV certifications received by patent owners to determine their materiality to patentability of any pending matters before the USPTO. “If the content of the detailed statement, or other information that is part of the ANDA process, is deemed material to patentability in a pending USPTO matter, then such information must be submitted to the USPTO during the pendency of the matter, to meet the duties of candor and good faith and disclosure under 37 CFR 1.56, 1.555, 42.11(a) or (c), or 11.18(b)(2),” the Notice states.Additionally, the Notice warns that merely submitting the FDA’s listing of paragraph IV certifications to the USPTO does not satisfy the duty of disclosure, since these lists “do not include patent numbers, relevant claims, or an explanation of the basis for the certification.”Importance of Consistency in Statements Before the USPTO and FDAThe Notice underscores the importance of consistency in statements made before the USPTO and the FDA. Specifically, the Notice states that “providing material information to other Government agencies, including the FDA, while simultaneously withholding the same information from the USPTO undermines both the intent and spirit of the duty of disclosure and violates those duties.”A recent Federal Circuit decision, <a href="https://cafc.uscourts.gov/opinions-orders/20-1799.opinion.9-1-2021_1828017.pdf">Belcher Pharmaceuticals v. Hospira</a> (Fed. Cir. Sept. 1, 2021), was cited as an example in which “inconsistent statements submitted to the Food and Drug Administration (FDA) to secure approval of a product—asserting that the product is the same as a prior product that is already on the market—can then be directly contradicted by statements made to the [USPTO] to secure a patent on the product.”In <a href="https://www.ipwatchdog.com/2021/09/02/federal-circuit-upholds-delaware-courts-inequitable-conduct-analysis/id=137298/">Belcher</a>, the Federal Circuit affirmed a district court’s ruling that a patent covering a formulation of the drug epinephrine is unenforceable due to inequitable conduct. In a new drug application (NDA) filed with the FDA, Belcher’s Chief Scientific Officer had submitted several prior art references disclosing an “old” pH range for the epinephrine formulation. During prosecution before the USPTO, however, Belcher failed to disclose the references submitted to the FDA, and argued that the claims were patentable because the same pH range was “was unexpectedly found to be critical by the Applicant to reduce the racemization of l-epinephrine.”Key TakeawaysBelcher illustrates the key tension between relying on existing information for regulatory approval and establishing novelty and non-obviousness for patentability purposes. Parties involved in proceedings before the USPTO or PTAB that are seeking FDA approval should take special care to ensure consistency and coordination of strategies. As part of the duty of reasonable inquiry, parties should ensure that information and statements received from or submitted to the FDA are reviewed by both FDA regulatory counsel and patent counsel for potential materiality to patentability and disclosure to the USPTO or PTAB. This duty cannot be avoided by deliberate schemes to prevent individuals with the duty of disclosure from obtaining knowledge of material information, which the Notice indicates is “inappropriate.”Finally, parties should err on the side of disclosure to avoid allegations of inequitable conduct. As stated in the Manual of Patent Examining Procedure and reiterated in the Notice, “[in] close cases where the materiality or consistency of the information is in question, the applicant should consider submitting this information to the USPTO.” Given the significant leadership attention this topic has received at both the FDA and the USPTO, and the political pressure on both agencies to assist in the Biden administration’s efforts to reduce drug costs, the FDA and USPTO are likely both considering enforcement tools that may be employed to ensure appropriate disclosures.

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

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. 

kingman_kelsey-roberts_blog_150x150.png

kingman_kelsey-roberts_common_640x280.jpg

kingman_kelsey-roberts_heroretina_2700x1160.jpg

kingman_kelsey-roberts_mobileretina_750x1040.jpg

kingman_kelsey-roberts_social_600x600.jpg

Patent Agent

Building on her research experience in cellular and molecular biology, Dr. Kelsey Roberts Kingman focuses her work on patent drafting and assisting prosecution, patent analysis, and patent due diligen

Kelsey J. Roberts Kingman Ph.D.

Kelsey Roberts Kingman

healthcare.jpg

Recent Biden Administration Efforts on Drug Pricing: USPTO Notice Focuses on Eliminating Inconsistencies in USPTO/FDA Statements

220829-healthcare-blog-post

On July 29, 2022, the U.S. Patent and Trademark Office (USPTO) issued a Notice in the Federal Register clarifying the duty of disclosure that may keep patent practitioners up at night. 

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.

grohmann_robert_blog_150x150.png

grohmann_robert_common_640x280.jpg

grohmann_robert_heroretina_2700x1160.jpg

grohmann_robert_mobileretina_750x1040.jpg

grohmann_robert_social_600x600.jpg

Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

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.

mofolifesciences-medical-devices.jpg

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

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

mofolifesciences-medical-devices

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)

Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post.The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD) tests, not just COVID-19 tests. During the height of the pandemic and while inundated with COVID-related submissions, CDRH restricted the IVD tests it would review in order to best address the public health crisis. Starting June 1, 2022, CDRH is again accepting all IVD pre-submissions, both COVID-related and other. However, the Center did include the caveat that non-COVID pre-submissions will likely still face an extended timeline, given the ongoing pandemic and associated workload.In another return to normalcy, CDRH plans to rescind an additional COVID-era policy that extended the grace period for deficient marketing submissions. Recognizing the effect the pandemic had on business operations, CDRH did not consider an application automatically withdrawn if CDRH did not receive a response by a certain date. Moving forward, the Center will be returning to its previous guidelines that require either a complete response or an extension request within the specified time. This policy change will go into effect 30 days after the official announcement from the FDA in the Federal Register, planned for June 7, 2022.For another point to watch, the Medical Device User Fee Amendment (MDUFA) commitment letter is currently moving through Congress. CDRH has committed to increasing communication between the FDA and submission applicants in order to reduce wait times.

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

Is 2021 the Value-Based and Shared Savings Revolution?

1023224308

Lindy Pittman, Summer Associate in Washington, D.C., contributed to the drafting of this post.
The U.S. Food and Drug Administration (FDA) released a statement 

FDA Will Once Again Accept Pre-Submissions for All In Vitro Diagnostic Tests

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.