EU regulations
The Medtech industry and its organizations recently called for the postponement of the implementation of the EU MDR and EU IVDR because of the COVID-19 pandemic. Medical device expert, Raquel Carnero Gómez, discusses the implications of the proposed May 2021 deadline in her article, COVID-19 impacts EU MDR’s proposed delay. In reviewing what manufacturers need to do to comply with the requirements, the author explains why many medical devices will likely be dropped from the market as manufacturers are forced to rationalize and optimize their medical product portfolios.
Stephan Affolter, a regulatory and quality intelligence specialist, considers the possible outcomes should Switzerland and the EU not renew their bilateral Mutual Recognition Agreement (MRA) on medical devices before May 2021, the proposed new date for implementation of the EU MDR. In EU MDR impacts MRA Switzerland–EU, the author reviews the countries’ long-standing relationship and predicts a “lose/lose” scenario for both industry and patients should the agreement not be updated on time.
Many regulatory changes were scheduled to come into effect in May 2022 as part of the new EU IVDR, but that date will likely be delayed a year because of the COVID-19 pandemic. Jordanna Jayne, a regulatory affairs specialist, writes that, regardless of any delayed deadline, the new guidelines present significant hurdles for manufacturers, particularly for those who do not already have devices on the market in the US. In EU IVDR changes regulatory landscape, the author assesses the new requirements for technical documentation, periodic safety reports, notified body changes, postmarketing surveillance and vigilance and labeling and product traceability under the EU IVDR.
Article 7 of the EU MDR and EU IVDR provides new medical device promotional and advertising product claims that regulatory professionals need to be aware of. In New claims under EU MDR and EU IVDR, Erik Vollebregt, legal and regulatory expert, discusses those claims and details how and when product claims are misleading or false as defined under the new regulations.
The linguistic translation process under the EU MDR will become much more complex, more so, because the EU has 24 official languages and the regulation stipulates the device information must be multilingual. In Preparing for EU MDR translation, Mark Aiello, a life sciences translator, discusses what medical device manufacturers need to know about product information language translation as required by the regulation and advises on how companies can better meet the regulation’s language component requirements.
A new update to ISO 10993-18 has prompted the EU medical device industry to exercise greater caution in its approach to chemical characterization and toxicological risk assessments. Sandi Schaible, a regulatory science expert, identifies the changes implemented by the update and explains their impact on companies working to certify devices under the EU MDR. Her article, EU MDR’s proposed delay and ISO 10993-18 compliance, explains how the one-year delay caused by the COVID-19 pandemic will likely not facilitate continued work on compliance.
Writer Raquel Billiones reviews the possible ramifications of the delay in launching Eudamed, the European Union’s new electronic database. Her article, Eudamed’s delay and its impact on clinical investigations under the EU MDR, uncovers potential drawbacks if clinical investigation data is not transparent or accessible and recommends that, until Eudamed is available, study results should be posted on other databases so that manufacturers can meet requirements for transparency and disclosure.
COVID-19 best practices
Following FDA’s announcement that it will hold virtual advisory committee meetings for some sponsors and other virtual “essential” regulatory meetings, many companies are scrambling to gear up for this new reality. In Preparing for virtual regulatory meetings, healthcare communications consultants, Jim DiBiasi and Cindy DiBiasi, outline the key steps to setting up for virtual meetings and the importance of having the appropriate technology in place for the call, as well as a technology professional on hand during the call to troubleshoot any hitches.
How important is communication during a crisis? Alicia Whittlesey, in Communication during a pandemic, offers best practices for company communication during an emergency such as the COVID-19 pandemic and emphasizes the need to ensure responsible company communications at all times, not just during crises. She discusses best practices for communication through many mediums and the importance of ensuring messages are not misinterpreted or misleading in any way that could negatively affect the company reputation or put it in legal jeopardy.
The COVID-19 pandemic highlights the need to plan for a remote internal auditing process, according to Tammy Pelnik, a quality management and assurance expert for medical- and drug-device manufacturers. In Optimizing remote internal quality audits, she provides tips and techniques for effective, risk-based remote internal quality auditing methods for a good manufacturing practice (GMP) quality management system.
Regulatory strategy and reform
RAPS has introduced the second edition of the Global Pharmaceutical and Biologics Regulatory Strategy, a comprehensive resource for regulatory professionals including updates from more than 30 leading regulatory experts, based on their real-world insights and experience. Topics include regulatory intelligence, strategies for chemistry, manufacturing and controls and how to interact with regulators. In Hear from the experts who wrote the book, three of the book’s authors, William Sietsema, Monica Meacham and Eric Brass explain why every regulatory professional needs this book in their library.
Barbara Kochanowski and David Spangler, regulatory executives from the Consumer Healthcare Products Association (CHPA), discuss the impact of over-the-counter (OTC) monograph reform,
part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act for pandemic relief in OTC monograph reform is now law: What’s next? The experts breakdown the details thought and explain the reform’s overarching affect on ensuring safe medicines for consumers.
What’s coming in May?
May articles will focus on a range of topics, relating to the implementation of a pharmaceutical regulatory operations outsourcing project, drug shortages, risk management with third-party vendors in regulatory affairs functions, in-house versus outsourced testing and good vendor management. Look for these topics and more throughout May at www.raps.org.
July call for articles
Regulatory Focus tackles global regulatory strategy for cell and gene therapy in July. The submission deadline is 1 June. To contribute to July or suggest a topic, contact rmatthews@raps.org.
Cite as: Matthews R. “EU device regulations, COVID-19 response and global regulatory strategy.” Regulatory Focus. May 2020. Regulatory Affairs Professionals Society.
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