Second Corrigendum for MDR 2017/745

On November 25th the European Council issued a second corrigendum to MDR 745/2017, in which the most significant change was made to article 120. In particular, it was confirmed that manufacturers of Class I medical devices now have a further 4-year transitional period, then until 26 May 2024, to meet the requirements of the new Regulation. Paragraph 3 of the art. 120 has been modified as follows:

“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues …”

Please refer to the following link for the second corrigendum of MDR 2017/745 (from page 44 English):

https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf