Four-year transitional period until 2024
MDR: some Class I medical devices will get a four-year transitional period until 2024 as per 2nd Corrigendum issued by European Council.
The Corrigendum on MDR (Nov. 25, 2019) states: “By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive93/42/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 …’.”