In May 2021, there was the implementation of the European Medical Devices Regulation, replacing the prior Medical Devices Directives (MDD) with the primary goal to increase the safety and effectiveness of all commercialized medical devices.
Such a change was necessary for a number of reasons:
1. Outdated regulations that had not kept up to date with technological developments such as the hybrid of hardware devices and software
2. A lack of consistency between European Union (EU) member states as the MDD were directives, not laws
3. A focus on approval rather than postmarket performance, with continued clinical assessment not mandated
4. Limited accountability, with liability upon the manufacturer rather than the distributor
5. An insufficient scrutiny of notified bodies, with a focus on one-time approval rather than an ongoing assessment of safety and quality
To address these issues, the new MDR has a number of changes:
1. A regulation with more binding characteristics, thus reducing inconsistency but still allowing for national autonomy to ban high-risk devices
2. Strict guidelines for notified bodies, which are to act in a more prescriptive nature with greater use of audit and post-marketing surveillance
3. Extension of definition of medical devices to include implantable and invasive devices but also software for medical purposes, products with medical attributes that are not intended for medical use, and those for cleaning, disinfecting, or sterilizing medical devices
4. Stronger regulations with a stricter criteria for equivalence including documentation and clinical data as well as a transition to a “life-cycle” style approach with ongoing follow-up and periodic safety reports
5. Expanded accountability measures including the need for manufacturers outside the EU to designate authorized representatives who share legal liability
6. Traceability and transparency including a unique device identifier that will be used across the EU to improve monitoring of safety-related outcomes, block falsified devices, and improve stock management. This will be integrated into the European Database on Medical Devices.
The implications of these changes may be widespread with both benefits and some consequences. Hopefully, this will result in safer devices and increased transparency, though at the cost of higher costs and commercialization delays. This may marginalize smaller companies and require others to make strategic decisions to prioritize certain products. Dr. Heesakkers feels that these changes make Europe less attractive as an entry point in the global medical device market place.
Presented by: John Heesakkers MD, PhD, Head of Unit of Functional Urology and Neurourology, Department of Urology, Radboud University, Nijmegen, the Netherlands
Written by: Christopher J.D. Wallis, MD, PhD, Urologic Oncology Fellow, Vanderbilt University Medical Center, Nashville, Tennessee, Twitter: @WallisCJD at the Virtual 2020 EAU Annual Meeting #EAU20, July 17-19, 2020