The formal standardisation request from the European Commission to the European standards bodies will get essential standards work to support compliance with Regulation (EU) 2017/745 on medical devices (MDR). The European Commission adopted and issued a standardisation request to the EU standards bodies in the context of the MDR, which now fully applies 26 May 2021.
The intention of the request was to ask the standards bodies, the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC), to amend and update current medical device standards and to outline new standards to make it possible for manufacturers to demonstrate compliance with the General Safety and Performance Requirements (GSPRs), which reinforce the MDR.
Standards that were assigned by the Commission to give a presumption of conformity with the essential requirements of the current medical device directives are known as ‘harmonised standards’. As the essential requirements have been superseded in the MDR by new GSPRs, all the linking must be done again before manufacturers can claim presumption of conformity by using EU standards to the GSPRs.
Although the Commission’s movement in making the standards request has been slow, the hope was that the one-year delay to the full application date of the MDR would give more time for the revised and new standards to be in place punctually.
On June 16, 2020, however, CEN and CENELEC rejected the Commission’s request. The reason seems to be a disagreement in the general (European or international) focus of the standards. Manufacturers who had to plan for compliance to the MDR in due time thus have another challenge to meet. If no harmonised standards exist, presumption of conformity with the GSPR cannot be made.
The industry association MedTech Europe has issued a paper in March how manufacturers could deal with this issue. You can view the document here.
In this context, it will be of essential importance that manufacturers address any gaps that may exist between the MDR and the standard they are using. (als Pullquote) The corresponding rationales should be readily available for submissions to Notified Bodies or competent authorities.
Sources: Medtech Insight (an Informa product)