A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and
safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 20203 . In contrast, the IVDR has a date of application of 26 May 2022.
In March 2020 and June 2021, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR.
The implementation of the IVDR has proven to be a very challenging task for the whole sector and all concerned: stakeholders, the European Commission and Member States. These have been working very hard to ensure effective implementation of the new rules. For example, the Unique Device Identifier system has been set up. The Eudamed database is under development. The IVD expert panel has been designated and experts appointed. A number of new common specifications are in development. The transition represents a significant challenge also for stakeholders such as manufacturers, notified bodies, authorised representatives and laboratories. Member States and the Commission, together with concerned stakeholders, have a joint responsibility to ensure that the new legislation is operational from 26 May 2022.
The actions mentioned in this updated implementation and preparedness plan have already been identified as priorities and work on them is ongoing. The priorities set out in this document have been identified based on the objectives of public health, patient safety and transparency, which are key to the new legislation, as well as the most urgent needs of the stakeholders.
For more information, read the plan