Due to the COVID-19 emergency, the European Commission proposed to postpone by one year the date of application of the Medical Device Regulation (EU) 2017/745 (MDR).
Earlier than expected, the postponement had been formalized the last 24 April with the publication of the Regulation (EU) 2020/561 of the European Parliament and Council in the Official Journal of the European Union.
This Regulation only moves the date of the MDR application to 26 May 2021 and does not change the regulatory content of the MDR, neither the novelties introduced by the II Corrigendum set out in December 2019 (e.g. the requirements for the class I medical devices to make use of the grace period remain unchanged, but they will be applied starting from 26 May 2021).
Besides reducing the risk of lack of fundamental medical devices for the management of the COVID-19 emergency, to have one more year available it will also allow:
- the manufacturers to implement the MDR requirements starting from 26 May 2021;
- the designation of further Notified Bodies for the conformity assessment according to the MDR (to date the EU database NANDO reports 13 Notified Bodies in the list relevant to the MDR designated Bodies);
- the Notified Bodies, which are not designated under MDR, to issue CE certifications according to the Directive 93/42/EEC for a further year;
- the Medical Device Coordination Group (MDCG) to issue several guidelines in order to support the manufacturers and the Notified Bodies to face with the new activities and new document introduced by the MDR.
RPN is available to support companies in all the regulatory steps for the route to the MDR implementation, please do not hesitate to contact us!