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May’s Regulatory Focus: EU MDR and EU IVDR update, and more

Posted 09 June 2021 | By Renee Matthews  | ©

May’s Regulatory Focus: EU MDR and EU IVDR update, and more

Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application deadlines, with specific focus on availability of resources (human and technological), access to notified bodies, and the ensuing time and cost implications for all parties.
 
Readiness and notified bodies
There was much discussion in the lead-up to the MDR’s May deadline about companies’ readiness for the impending changes and whether the deadline extension to 2021 had made a difference. In EU MDR countdown: Readiness of medtech companies in Europe, Veronika Schweighart and Catherine Higginson report on findings from a survey launched just under 3 months before the MDR cut-off date to evaluate EU-based medtech companies’ readiness for the impending changes. The postponement seemed to have helped some companies, though many respondents said they still felt unprepared for the new demands and most indicated a need for clearer guidelines from the European Commission. More companies seem to have made progress in the intervening year in finding an MDR-certified notified body to work with, although almost a fifth still have no notified body at all. Many respondents also expressed concern about the drain on time and financial resources, especially in regard to clinical data capture. For regulatory professionals, the main challenges seem to center on compliance with the stringent requirements for classes I and IIa products.
 
In EU IVDR countdown: Opportunities await, but concerns linger over notified bodies, Jo-Ann Fabila Gonzales highlights the importance of manufacturers fully understanding the changes that will come with the May 2022 IVDR to ensure compliance with the new requirements and a smooth transition to placing and maintaining safe, effective products on the market. On the one hand, she cautions that EU-certified IVDR notified bodies are overwhelmed with product review applications and time is running out for manufacturers to get conformity assessments completed in time to meet the looming deadline. On the other hand, the IVDR’s more stringent clinical evidence requirements may create more global commercialization opportunities and enhance safety, quality, and innovation.
 
Harmonzation and lifecycle management
Human tissue is newly introduced to the scope of the MDR, and, although it offers the opportunity for uniform market access of device/tissue products, the ongoing lack of clarity and borderline challenges remain. Those challenges are centered on linking a harmonized device framework with a nonharmonized human tissue framework. In MDR scope extension with human tissue: Regulatory implications and concerns, Jeroen Pieper and Richard van der Linden discuss the regulatory implications of the scope extension of the MDR with human tissue, outlining the specific additional consultation procedure as part of the conformity assessment and comparing the US and EU frameworks for tissues and combination products. The authors also warn about a shortage in the number of available notified bodies and address concerns over decentralized regulatory oversight for tissues and the absence of an “article 117” analog and guidance for borderline device/tissue products. These issues, they suggest, may hamper development and availability of such combination products to EU patients.
 
Given the extent of the changes under the MDR, organizations are being challenged to take a more holistic viewpoint of their products, resources, and regulatory toolkit to maintain product compliance in the EU. In Strategic lifecycle approach to medical device regulation, Seyed Khorashahi and Mark Agostino note that lifecycle management is one of the components to maintaining regulatory compliance and that there are unique approaches to lifecycle management that should be considered under the new MDR. Postmarket surveillance helps establish a process for identifying and rectifying issues during the course of the product lifecycle; notified bodies now have a process to absorb the feedback from clinical evaluations to ensure medical devices being designed and manufactured meet the stated intended use. The unique device identification makes it easier to prioritize which issues need to be addressed and to ensure tracking mechanisms are in place so field corrective actions can be accurately executed and products easily removed from the supply chain when necessary. A quality management system comprised of all the aforementioned elements will provide a company the closed-loop feedback needed from the real-world situations to improve clinical performance.
 
New focus for MHRA
After the UK’s January 2021 withdrawal from the EU, the Medicines and Healthcare products Regulatory Agency (MHRA) became the UK’s standalone medicines and medical devices regulator. In The UK regulatory landscape post Brexit, Beatriz Criado and Maurice Bancsi examine the rules drug developers now have to follow to get their products approved for the UK market. They highlight the most relevant initiatives, including guidances, grandfathering of centrally authorized products, reliance procedures an abbreviated assessment procedure for products that have already gone through the EU procedures, the innovative licensing and access pathway, rolling reviews, and pediatric investigation plans.
 
Upcoming in Regulatory Focus
What’s coming in June?
Articles during June will examine nutrition in health and disease management, and the gut microbiome.
Look for this topic and more throughout June at Regulatory Focus.
 
And July?
For the July issue, Regulatory Focus will examine Real-World Evidence and Data.
 
Call for articles
August monthly issue
In August, Regulatory Focus will cover Alternative Regulatory Pathways. The submission due date for articles is 30 July 2021. To contribute, email rmatthews@raps.org.
 
Upcoming in RF Quarterly
Regulatory Focus launched the inaugural issue of RF Quarterly in mid-March, and the summer issue, focusing on artificial intelligence, is now available.
 
Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit. The themes for the rest of 2021 will be:
 
  • Quality and Compliance in Regulatory Affairs (September)
  • RAPS 2021 Convergence (December)
 
To contribute to the September issue of RF Quarterly, email rmatthews@raps.org.
 
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.
 

 

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