The corrigendum proposes to alter Article 120(3) of the MDR by inserting (additions underlined): "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..."
Does the Second MDR Corrigendum for Class I Devices allow for a Declaration of Conformity DOC) to be drawn up prior to 26 May 2020 which will allow the length of validity be the same (26 May 2024) as that for which the conformity assessment procedure pursuant to the MDR requires the involvement of a Notified Body (NB).
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Robert Wilkinson
President
Port Barrington IL
United States
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