Second Corrigendum of MDR (EU) 2017/745: Will class 1 devices get an extension?
Date: 27 November 2019
On 25 November 2019, the Council of the European Union published a second corrigendum to MDR (EU) 2017/745. The corrigendum includes overall 12 edits, corrections or additions, changing Article 78, 84, 88, 120, 122 and Annex I and III.
The most significant change affects class I medical devices, for which the conformity assessment procedure requires the involvement of a notified body. Such devices, for which the declaration of conformity was drawn up prior to 26 May 2020, could be placed on the market or put into service until 26 May 2024. This addition is suggested to Article 120 paragraph (3), which was previously only related to devices that already had been certified by notified bodies. In addition, Article 120 paragraph (4) should be modified to include all products related to paragraph (3). This second change would effectively allow these devices to be made available on the market and put into service until 26 May 2025. The change applies to class I devices, which are sterile, include a measuring function, or are reusable surgical instruments.