Setterwalls has previously reported that the EU Commission has been working on a proposal to postpone the implementation of the new regulation on medical devices, MDR, for one year. The Commission has now put forward a proposal meaning that the implementation of the MDR is postponed by one year, i.e. to 26 May 2021. However, the proposal does not concern the In-Vitro Diagnostics Regulation, IVDR, which still is to be implemented by 26 may 2022.
The new regulations on medical devices, MDR and IVDR, are set to replace the existing EU directives on medical devices. The EU directives have been implemented in Sweden through various laws, regulations and provisions. Since the MDR and IVDR are EU regulations rather than EU directives, they will be directly and fully enforceable in the member states without implementation through any national procedures. The regulations reinforce the existing procedures but also introduce, for example, provisions ensuring transparency and traceability regarding medical devices. The MDR is supposed to become applicable from 26 May 2020, i.e. in about one and a half months, and IVDR is set to become applicable from 26 May 2022.
However, with reference to the COVID-19 outbreak, MedTech Europe (the trade organisation for medical device companies), called for a postponement of the implementation of MDR and IVDR through a press release on 23 March, see here. Shortly thereafter, the EU Commission communicated that work on a proposal to postpone the implementation of MDR by one year was ongoing, see here. The Commission has now adopted a proposal.
The proposal states as a background that the COVID-19 crisis has created extraordinary circumstances that have a significant impact on many areas covered by MDR. Further, many medical devices play a crucial role in the fight against the COVID-19 outbreak. Thus, the Commission concludes that it is very likely that member states, companies, health institutions and other affected parties would not have been in a position to ensure the proper implementation and application of MDR on 26 May 2020.
Therefore, in order to ensure the objectives behind MDR, to provide legal certainty and to avoid a potential market disruption, the Commission suggests that the application of MDR should be postponed by one year. The proposal will be handled through an accelerated co-decision procedure, requiring the support of the EU Parliament and the Council.
The proposal in its entirety is available here. Setterwalls is monitoring the developments and will keep you updated on the matter.