MDR Corrigendum: Derogation for certain up-classified devices

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 . . .

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