Application dates of the Regulation on Medical Devices (MDR)

The Regulation on Medical Devices has been published in the Official Journal of the EU on 5 May 2017.

Application dates derived from the publication date:

Entry into force of MDR and start of voluntary applicability for manufacturers: 26 May 2017.

Mandatory applicability of MDR and, in principle, end of applicability of Directives: 26 May 2020.

Last day by which devices may be placed on the market under the MDR, but on the basis of a certificate issued under the Directives and with applicability of certain requirements of the Directives and some others of the MDR (see Article 120-3): 25 May 2024.

Last day by which devices placed on the market under the Directives or placed on the market after 25 May 2020 on the basis of a certificate issued under the Directives may be sold by distributors: 27 May 2025.

Please note that the dates partly differ for the Regulation on in vitro diagnostic Medical Devices (IVDR), which is accessible via the same link.