As set out in our previous post, it is two months until the (current) date of application of the Medical Devices Regulation (MDR) on 26 May 2020. In this series of posts, we wanted to update you on the state of implementation given the fast-approaching deadline. However, as we were speculating that the current timeframe was looking increasingly untenable, the Commission announced yesterday (25 March) that it was working on a proposal to postpone the date of application by a year. This is intended to allow national authorities and industry to focus on responding to the coronavirus crisis.
The statement notes that “The Commission is working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May.” It has also been reported that the Parliament is receptive to such a proposal, and is aware of the tight timeline.
While we don’t yet know what the terms of the proposal will be, or how it will operate with all the various transitional provisions within the MDR, it will be welcome news to the industry, which is already under pressure due to the new provisions under the MDR, and now the coronavirus pandemic. We will keep you updated as more information is published.