The rumors on the revised transitional provision [Article 120(3) of the MDR] are confirmed, as a new version of the Corrigendum was published.
However, the text remains open for Member States’ comments for 7 days:
‘’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 …’’
It therefore allows newly up-classified devices under the MDR, with a need of a Notified Body (for ex. surgical instruments) to be placed on the market after 26 May 2020 under the ‘’old regime’’ while respecting only certain requirements of the MDR, i.e. post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices, provided there are no significant changes to the design and intended purpose of a device. The sharp deadline is therefore pushed to 2024 for these devices.
There is also a clarification on the Article 120 (4) – devices lawfully placed on the market before 26 May 2020:
- Before: ‘’on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025’’
- Now: ‘’… on the market from 26 May 2020 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.’’
As well as Article 120 (8) that concerns compliance with national laws for registration of devices and actors.
There are some additional corrections to the text of the Regulation, and you can find the link to the full Corrigendum here: English version on Page 43-48