The European Commission intends to extend the transition period under the Medical Devices Regulation (EC) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before). Low notified body capacity is a key contributing factor for the transition delays.
In order to address shortage risks over lifesaving medical devices for EU patients, Stella Kyriakides (Commissioner for Health and Food Safety) announced today (December 9, 2022) to the Employment, Social Policy, Health and Consumer Affairs Council several key proposals to address these concerns and safeguard patient safety:
- The relevant transition periods for medical devices approved under the Medical Device Directive 93/42/EEC (MDD) will continue to apply until 2027 (for high-risk devices) and 2028 (for medium and low-risk devices). However, only devices that are “safe” will benefit from the extension. Further, there is a suggestion that manufacturers must have actively started the MDR re-certification process to benefit.
- The May 2025 sell-off date for medical devices authorised under the MDD will be repealed to prevent safe medical devices from having to be discarded.
- Further medium and long term solutions will be developed to address the needs for rare disease devices, which will aim to safeguard patient safety with less bureaucracy.
- To foster innovation, the Commission will launch a new pilot scheme to offer scientific advice from expert panels to medical device manufacturers. The scheme will be targeted at manufacturers of rare disease and breakthrough devices. The Commission will also work on providing additional support to small and medium-sized enterprises (SMEs).
Details of the specific legislative changes have yet to be announced. It is not expressly stated whether the changes would include extending the validity of certificates issued under the MDD. However, we would query the benefit of the proposed extension if this is not the case. It is also unclear if the proposed changes will also affect in vitro medical diagnostic devices (IVDs) that are yet to transition to Regulation (EU) 2017/746 (IVDR).
The legislative process to enact the changes is expected to begin in early 2023. We will continue to monitor the situation and provide further updates.