The new European Union Medical Device Regulation (EU MDR) was published in the Official Journal of the European Union on May 5th 2017 and “entered into force” 20 days later on 26 May 2017.
Readers should be aware that “entry into force” isn’t the same as being applicable. The existing Medical Device Directive (MDD) remains applicable, as there will be a transition from the current MDD to the new EU MDR. The end of the transition coming for the final few devices, potentially as late as 27th May 2025.
The details of the repeal of the current MDD are described in the new Article 122, with the transitional provisions being described in the new Article 120.
The key dates are as follows;
- Entry into force of the EU MDR - 26th May 2017
- Earliest date Notified Bodies may apply for designation according to the EU MDR - 26th Nov. 2017
- Earliest date EUDAMED can go live - 26th Mar. 2021
- Date of application of the EU MDR - 26th May 2021
- Notified Body certificates issued under MDD designation become void (if not already expired) i.e. the last possible date for placing devices on the market according to the MDD - 26th May 2024
- Last possible date for putting devices into service according the MDD - 26th May 2025
In theory, the new EU MDR could be adopted by manufacturers of medical devices immediately after its entry into force in May 2017. In practice however, the new infrastructure required by the EU MDR; the new EUDAMED database, the new registration and reporting procedures etc., will not be put in place by the European authorities for several years and transitional arrangements will have to be put in place. Neither will any of the new Notified Bodies be designated under the new EU MDR immediately after publication. Initial estimates suggest the first of the newly designated Notified Bodies will only be able to accept applications for product approvals well into 2019. Meaning with the first devices requiring Notified Body approval under the new EU MDR are unlikely to be approved before 2020.