In order to prioritise focus of Member States, health institutions and economic operators on the fight against COVID-19 pandemic, the European Parliament and the Council has today approved to postpone the Date of Application (DoA) of the Medical Device Regulation (EU) 2017/745 (MDR) 26 May 2021 for exceptional reasons, by means of Regulation (EU) 2020/561.
Originally, the DoA was set on 26 May 2020. The decision to postpone it to 26 May 2021 has been made in order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, mainly due to the COVID-19 current outbreak and its epidemiological development. During these exceptionally hard times, it is in fact essential to help fighting the pandemic by providing additional resources and increase availability of vitally important medical devices on the market.
Regulation (EU) 2020/561 has two aims:
- To prolong the transitional period by postponing the application of certain provisions and deferring the repeal of most of the provisions of the Directives 93/42/EEC and 90/385/EEC until 26 May 2021;
- To allow adoption of Union-wide derogations from the regular conformity assessment procedures for specific devices in the interest of public health, to make such devices rapidly available and accessible for users.
Following this approval, medical devices can still be placed on the market under the Directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices until 26 May 2021. Also, medical devices placed on the market pursuant to Directives 93/42/EEC and 90/385/EEC prior to 26 May 2021, may continue to be made available on the market or put into service until 26 May 2025.
The new DoA will also impact single-use devices and their reprocessing, the functionality of EUDAMED, UDI and the intervention of an expert panel within the conformity assessment procedure of certain classes of medical devices.
The new DoA will also have strong impact on the conduct of Clinical Studies as well as on the reporting of serious events and device deficiencies, as these can still be carried out according to the Directives up until 26 May 2021.
These are just some of the few impacts this postponing of DoA has set in place. If you are interested in more details or seek for assistance, please contact us as we can assist you and your company throughout this new transitional scenario.