EU Medical Device Regulation: What Should You Do During the Delay?

Medtech’s countdown to the European Union’s Medical Device Regulation was reset when the EU Commission, Council, and Parliament delayed the regulation’s application to May 2021. The delay “takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis,” according to the commission. 

While the response to the COVID-19 pandemic remains a top priority, are there any steps medtech companies could continue to take toward implementation? Could the delay help companies fully address the most challenging aspects of the new regulation?

MD+DI has assembled several experts to explore several aspects of the EU MDR in the new webinar series, “EU Medical Device Regulation: What Does Postponement Mean for Medtech?” Topics include risk management, clinical evaluation reports, new expectations for material evaluation, newly required testing, postmarket product surveillance, and much more. Attendees will learn how to conduct a gap analysis, how to develop strategies for MDR compliance, how to avoid common pitfalls, and much more.

Please join us for the following webinars now available on demand:

“EU regulatory requirements and expectations are significantly increased with the new EU MDR and IVDR,” Kimberly A. Trautman, Executive Vice President, Medical Device International Services, NSF Medical Devices, told MD+DI. “While the date of enforcement has been extended until May 2021, many companies that have started with their Notified Bodies on Technical Document review are receiving major nonconformance or deficiencies that related to inadequate foundational risk management data and decisions. This is already requiring those manufacturers trying to be 'early to the game' to undertake unexpected remediations delaying their original timelines for EU MDR certification. Do not be caught in this situation! Understand what is needed both from the EU regulations, as well as the new ISO 14971:2019 standard, so your company is prepared for success.” In "New Risk Management Requirements under the EU Medical Device Regulation," Trautman examines the new edition of ISO 14971:2019, “Medical devices – Application of risk management to medical devices,” which she describes as “a standard heavily relied upon within the EU regulatory framework.” She also discusses the new edition of ISO TIR 24971:2020, “Medical devices – Guidance on the application of ISO 14971.” 

In "A Year of MDR Remediation: Strategies and Lessons Learned," Matthew R Jorgensen, senior chemist and toxicologist for Nelson Laboratories, shares lessons learned during preparations for the new rules. He explores key changes in the new MDR such as newly required testing and share experiences from MDR remediation processes to help attendees avoid common pitfalls.

Justin Metcalf, director of engineering services, and Theodore Heise, PhD, RAC, both with the MED Institute, provide an overview of a few aspects of the new European MDR, including the need for gap analyses and resulting testing requirements, in "Practical European MDR Activities and Strategies: GAP analysis activities and practical execution." They explore common issues and some potential approaches.

Todd McDonald of Sonoco TEQ covers the material needs of a sterile barrier system and explore the potential benefits of using HDPE in "Five reasons to use HDPE in a sterile barrier system." He will share TEQ's stability study data on HDPE, details on the sustainability of HDPE, and more.

And Jacqueline A. Anim, Principal Materials Engineer for Ethicon & OneMD (JNJ), examines new expectations for evaluating materials to be used in single-use devices, repeat-use devices, digital and robotic surgery devices and instruments in "Understanding the EU MDR’s Impact on Material Selection." The session will also offer attendees suggestions for developing their own material selection strategies. 

Plese join us for these sessions in the webinar series, “EU Medical Device Regulation: What Does Postponement Mean for Medtech?” now available on demand.