As we reach the second anniversary of the date of application of the EU’s MDR, it’s an excellent opportunity to reflect on the journey and the challenges ahead for manufacturers.
The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges, ranging from the availability of competent resources to the adjustment to more stringent requirements, such as the collection of post-market data. The delays in availability of guidance documents—including those issued by the Medical Device Coordination (MDCG) and harmonized standards—have also posed a hurdle for stakeholders.
Since the date of application in May 2021, the number of MDCG guidance documents has approximately doubled and now totals more than 100. Of the c. fifty new additions, two-thirds pertain to the MDR, the most recent being MDCG 2020-3 Rev 1, Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.
This guidance, for manufacturers of ‘legacy devices,’ arose following the decision taken by the European Commission, later adopted in February 2023 by the European Parliament, to extend the MDR transition periods giving manufacturers more time (up to 2027 and 2028 for high-risk and lower-risk devices respectively), to certify their devices and to avoid a shortage of life-saving products in Europe. The extension is welcome. This is especially true for Notified Bodies who are face challenges reviewing numerous MDR applications. It is advised that manufacturers progress their submissions and work with Notified Bodies to schedule assessments well before the given deadlines.
While progress has been made, and regulators have taken difficult—but correct—decisions to extend the transition, challenges remain for manufacturers in adapting to the new regulatory landscape. Clinical evaluation and post-market surveillance are two key areas where the MDR imposes stricter requirement; manufacturers should recognize and plan to address these as soon as possible. Understanding the requirements and implementing the necessary activities is key to ensuring the new timelines will be met.
To learn more about the EU MDR transitional provision extensions, we invite you to watch the following video with leading EU regulatory expert, Adrian Keene (Associate VP, Global BS&V and EMEA Consulting Services).
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of Medical Device and IVD experts communicate with EU entities nearly every day and are the most experienced in the industry at accelerating regulatory submissions and approvals for manufacturers. Many of our Associates have previously held positions within these organizations, which provides Clients with the benefit of a more precise understanding of how to proactively plan for international requirements and expectations.
Make sure you’re on the right track! If you are interested in scheduling a complimentary consultation with one of our EU MDR experts, we invite you to do so here: https://namsa.com/namsa-expertise/subject-matter-experts/.
David Mandley, PhD
David joined the Regulatory Consulting Team at NAMSA in 2021 and currently serves as a Principal Regulatory Consultant. Mr. Mandley has more than 20 years’ experience in the medical device industry working with a range of product types and organisations from university spin-outs to multinationals. Following completion of his doctoral research in Applied Photochemistry at Loughborough University, David held various roles for a UK-based SME, Tissuemed, including Research & Development, QA, RA—culminating into serving as CEO for eight years. During this period, David was pivotal in the development, regulatory approval and commercialisation of a range of implantable, resorbable surgical sealants indicated as adjuncts for the prevention of intra- and post-operative leaks, including air, blood and cerebral spinal fluid. More recently, Mr. Mandley has worked as a regulatory consultant for a range of multinational medical device manufacturers, leading MDR submissions for a variety of device types and classifications (I – III) from wound care devices and their accessories, combination products and radiofrequency ablation systems.