EU: Longer transition period for the Medical Devices Regulation

 

EU published a Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD Regulation) establish a new regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products.

The MD Regulation has been applicable since 26 May 2021; it provides for a transition period that will end on 26 May 2024.  The IVD Regulation has been applicable since 26 May 2022.

In spite of substantial advancements in recent years, the capacities of ‘notified’ bodies responsible for conformity assessment remain inadequate, and manufacturers are insufficiently equipped to meet the heightened requirements of the MD Regulation within the stipulated timeframe. This situation poses a threat to the availability of medical devices within the EU market. The challenges are exacerbated by the influence of the COVID-19 pandemic on clinical investigations, onsite audits, and the global supply chain.

This proposal aims to prolong the existing transition period outlined in Article 120 of the MD Regulation, contingent upon specific conditions. These conditions are designed to ensure that only devices deemed safe and for which manufacturers have already begun the transition to the MDR will benefit from the extended timeline. This extension would provide manufacturers and notified bodies with additional time to carry out conformity assessment procedures in accordance with the MDR, granted the fulfillment of the conditions. The draft proposal suggests a staggered extension of the transition period based on the risk classification of the device—up to 2027 for higher-risk devices and up to 2028 for medium and lower-risk devices. The extended transition period would also include the prolongation of certificate validity issued under previous Council Directives 90/385/EEC and 93/42/EEC for devices covered by the extended transition.

Additionally, the proposal recommends the removal of provisions concerning the ‘sell-off’ date from both the MD Regulation and the IVD Regulation. The ‘sell-off’ date refers to the last date on which devices placed on the market before or during the transition period can continue to be made available in the supply chain after the transition period concludes. By eliminating these provisions, the unnecessary disposal of safe medical devices that are already in the market but have not yet reached the end user could be avoided.

The text of the proposed regulation is available HERE.