Confirmed: Date of MDR application put back by one year

Following our post on the 26th March regarding the European Council (EC) proposal to delay the Medical Devices Regulation (MDR – 2017/745) due to COVID-19, the proposal has been overwhelmingly backed by the European Parliament and was published in the Official Journal on 24th April.

The adoption of this proposal by the EC means that the date of the application of the MDR will become 26th May 2021 instead of 26th May 2020.

After the vote, the European Parliament issued the following statement “Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year”.

Image by Freepik

This postponement will relieve some pressure on manufacturers, notified bodies and national authorities, allowing them to focus on fighting COVID-19.

Here at JensonR+, we will be continuing to monitor the situation in 2020 and beyond, so follow us on LinkedIn to receive any updates. If you would like to discuss the potential impact of this change to your business, then please do not hesitate to contact us at consultancy@jensongroup.com.