29 November 2019

The second MDR Corrigendum published by the European Council: the main changes proposed.

On November 25, 2019 the European Union Council published the second corrigendum to the EU Medical Devices Regulation 2017/745 (MDR) which includes corrections and clarifications. Among the changes, the most relevant is the four additional years for Class I devices’ manufacturers to conform to the requirements.


In particular, the corrigendum proposes to edit Article 120 (3) by inserting (underlined additions):
"By way of derogation from Article 5 of this Regulation, a Class I device within the meaning of Directive 93/42/EEC, for which a declaration of conformity has been drawn up before 26 May 2020 and for which the conformity assessment procedure under this Regulation requires the involvement of a notified body, and a device with a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC and valid under paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024 provided that as from 26 May 2020 it continues ...".

However, Article 120 also notes that the requirements of MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to medical devices placed on the market after the application date of the Regulation.

The final date for placing on the market and putting into service, mentioned in paragraph 4, is corrected to 26 May 2025. The previous date was 27 May 2025.

This legislative act of the Council of the Union makes further minor modifications to Articles 122, 78, 84 and 88, as well as to Annex III. For more information and details, please find the link below.

In all cases, to take effect, the Corrigendum must be published in the Official Journal.