23 Apr Coronavirus situation delays implementation of EU Medical Devices Regulation 2017/745 by one year
With patient health and safety as a guiding principle, the European Commission adopted on 3 April a proposal to postpone the date of application of EU Regulation 2017/745 on Medical Devices (MDR) for one year.
The aim is for the Parliament and Council to adopt the document by the end of May 2021. This postponement will remove pressure from national authorities, notified bodies, manufacturers and other stakeholders. This will allow the agencies to focus fully on urgent priorities related to the coronavirus crisis.
As we explained in our article last March, 26 May this year was the deadline to start implementing the MDR, which repeals Directive 90/385/EEC (AIMDD) and Directive 93/42/EEC (MDD).
Amendments to the regulation
Following the proposal published in April, this document, which entered into force on 25 May 2017, will apply from 26 May 2021, the text having been amended as follows:
1.- In Article 120 (Transitional provisions) in paragraph 6: replace the date “26 May 2020” by “26 May 2021” in the first and second sentences of the following text:
“By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies complying with this Regulation may be designated and notified before 26 May 2021. Notified bodies that are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures set out in this Regulation and issue certificates in accordance with this Regulation before 26 May 2021.”.
In Article 120 (Transitional provisions) in paragraph 6: replace the date “26 May 2020” by “26 May 2021” as follows:
“The products falling within the scope of this Regulation in accordance with the article 1, section 6, letters f) and g), which have been lawfully placed on the market or put into service in accordance with the rules in force in the Member States before 26 May 2021 may continue to be placed on the market and put into service in the Member States concerned’.
In Article 123 (Entry into force and date of application) in paragraph 3, point (f), part of point (f) is deleted and the text is maintained as follows:
“for implantable devices and for Class III devices, Article 27(4) shall apply from 26 May 2021; for Class IIa and IIb devices, Article 27(4) shall apply from 26 May 2023; for Class I devices, Article 27(4) shall apply from 26 May 2025;