EU - Proposal for a Regulation of the European Parliament and of the Council 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 May 26, 2021; it provides for a transition period that will end on May 26, 2024. It was notified to the WTO as notification G/TBT/N/EU/71.

The IVD Regulation has been applicable since May 26, 2022. It was notified to the WTO as notification G/TBT/N/EU/72. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from May 26, 2025 for high risk in vitro diagnostics to May 26, 2027 for lower risk in vitro diagnostics. It was notified to the WTO as notification G/TBT/N/EU/845.

Despite considerable progress over the past years, the capacities of conformity assessment  ('notified') bodies remain insufficient and manufacturers are not sufficiently prepared to meet the strengthened requirements of the MD Regulation on time. This is threatening the availability of medical devices on the EU market. The situation is exacerbated by the impact of the COVID-19 pandemic on clinical investigations, on-site audits and global supply chains.

This proposal aims to extend the current transition period laid down in Article 120 of the MD Regulation, based on certain conditions. The conditions would ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time. This would give manufacturers and notified bodies more time to conduct the conformity assessment procedures in accordance with the MDR, if those conditions are fulfilled. The draft measure proposes a staggered extension of the transition period depending on the risk class of the device, i.e. until 2027 for devices with a higher risk and until 2028 for medium and lower risk devices. The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Council Directives 90/385/EEC and 93/42/EEC for the devices benefiting from the extended transition period. Also the validity of certificates that have already expired since May 26, 2021 would be extended.

It also proposes to remove the provisions in the MD Regulation and in the IVD Regulation on the 'sell-off' date, i.e. the end date for the further making available of devices which are placed on the market before or during the transition period and which are still in the supply chain when the transition period is over. This would prevent unnecessary disposal of safe medical devices, which are already on the market but not yet with the final user.