State of Play: The Implementation of the Medical Device Regulations in Europe
Summary from RMD 2023
Raised Concerns Related to Implementing the Medical Device Regulations (MDR)
The European Commission (EC) has announced several key changes and improvements with the implementation of the new MDR, such as reinforcement of rules on clinical evaluation, reinforced designation, oversight processes of notified bodies (NBs), enhanced post-market surveillance and vigilance, and improved transparency and device traceability.
Despite the publications of guidance and the designation of NBs, several concerns are raised especially related to the risk of medical device shortages due to expiring certificates, the insufficient overall capacity of NBs, and the low number of manufacturers’ applications to NBs.
More than 80 NBs were designated under the Medical Device Directive (MDD), yet only 45 are currently designated under the MDR. Moreover, the time for a NB to deliver a MDR certificate ranges between 6 and 18 months and it is estimated that over 13,000 medical devices will require MDR certification in 2024, which may lead to a NB bottleneck.
Amendment to Extend MDR Transition
To address these concerns, the European Parliament voted on 16 Feb 2023 to approve an amendment to extend the transition deadlines to the new MDR for some legacy products:
Until December 2027 for legacy class III/IIb devices (except certain “well-established technologies” i.e., sutures, staples, dental filling, etc.)
Until December 2028 for class IIb “well established technologies”, IIa devices and class I devices placed on the market in sterile condition, with measuring functions or reusable surgical instruments.
These deadlines are fixed around the requirements to apply to a notified body by May 2024, and sign a contract for the certification by Sept 2024. The EC also has removed the sell-off date of 26 May 2025.
State of Play of the Manufacturers
Despite this amendment to the MDR, MedTech Europe are concerned that the implementation of the new MDR may negatively affect the European market. According to a manufacturers’ survey, around half of the responders do not intend to transition some of the products in their portfolio and are de-prioritizing the European market, which could lead to an innovation slowdown in Europe. Moreover, small European companies may be unable to cope with the consequences of the MDR.
State of Play of the NBs
On their side, NBs are working to harmonize views and practices with the new MDR requirements. NBs highly recommend European manufacturers to book a slot in advance with them in order to guarantee the MDR transition of their products on time. They also recommend manufacturers give special attention to the technical documentation of their products, especially to provide a complete, consistent, clear and updated presentation of documents and data. Moreover, the clinical evaluation report should contain sufficient clinical data covering all clinical indications described. Finally, sufficient justification should be provided for not conducting a clinical investigation.
Consequence of the New MDR on Medical Devices Involving Artificial Intelligence (AI) or Software
The new AI act in healthcare is now in preparation with the goals of regulating AI to minimize risks and to ensure trustworthy AI. It is expected to be applied at the end of 2025 or beginning of 2026. The AI act proposal is difficult to operationalize due to conflicts and administrative inefficiencies with the MDR (especially for eye surgery). It is estimated that a medical device using AI will take three times longer to obtain a MDR certificate in Europe compared to an FDA approval in the US.
The new MDR is also more demanding for clinical information regarding software. There is also a change in the classification based on the inherent risks, and these products now require a NB under the MDR requirements.
Conclusion
Despite the publications of guidance and standards and the designation of NBs, only a few manufacturers have obtained MDR certificates for their products. Even if the deadline extension is approved, it is recommended that manufacturers find a NB as soon as possible to guarantee a smooth transition of their products. The level of clinical evidence required under the MDR will more likely increase the need for conducting clinical studies to assure patient safety and product performance.
