Possible deferral of the entry into force of EU Medical Devices Regulation

On 25 March 2020, the European Commission announced that it is working on a proposal to postpone the date of application of Regulation (EU) 2017/745 on medical devices, set for the 26th of May 2020, by one year.

The European Commission aims at presenting the proposal to the European Parliament and the Council early April and it is urging the institutions to adopt the proposal as quickly as possible, as the date of application is at the end of May this year.

The postponement seeks to lift pressure from national authorities and industry and to allow them to focus on urgent priorities related to the current health crisis.

What does this mean?

This means that both Member States and manufacturers will have one additional year to come into compliance with the requirements laid down in the Medical Devices Regulation and that medical devices placed on the market in accordance with Directive 93/42/EEC on medical devices can continue to be lawfully made available on the market in the EU.

Is the European Commission doing anything else to help Member States and medical device manufacturers deal with the current health crisis?

Yes. On 24 March 2020, the European Commission also adopted decisions on harmonised standards to facilitate a faster and less expensive conformity assessment procedure. This will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The revised harmonised standards play a critical role in the current coronavirus pandemic because they relate to critical devices such as:

• medical face masks;
• surgical drapes, gowns and suits;
• washer-disinfectors;
• sterilisation.

For more information, contact Claudio Mereu or Selma Abdel-Qader.