Medical Devices Regulation update and COVID-19 impact
News: 27 March 2020
The European Commission (EC) has issued a communication to the Medical Device Coordination Group (MDCG) members that it is currently working on a draft proposal to postpone the Date of Application (DoA) of the Medical Device Regulation (MDR) for one year. The proposed delay is due to the exceptional circumstances associated with the COVID-19 pandemic and the potential impact it will have on the MDR implementation.
The EC intends to submit this proposal in early April to the EU Parliament and EU Council with a strong recommendation to rapidly adopt the proposal as we approach the DoA for the MDR on the 26 May 2020. This has been confirmed by the EC spokesperson, Stefan de Keersmaecker as per the video below (please open the following link in Chrome): https://audiovisual.ec.europa.eu/en/video/I-187348
If approved this will, without a doubt, bring some welcome relief from the intense pressure to complete the MDD/AIMDD work before the 26 May 2020. However, this is currently a draft proposal and will have to go through the EU Council and the EU Parliament to be ratified. The full details of the proposal are not yet known. There is no guarantee that this will be adopted and, if it is, it will not be ratified until at least mid-April.
BSI will continue with its efforts to complete all Directive work by the 26 May 2020 as originally planned.
There is still a mountain to climb to ensure all products meet the MDR timeline, so we recommend you maintain your current focus until we have received official confirmation of whether the DoA will be delayed.
Gary Slack Senior Vice President – Global Medical Devices