Former Class I device that is upscaled to IIa if the MDR is delayed

#1
Hello everyone. I hope you are all healthy and doing well. I have a question.

If the extension for applying the MDR takes place, a former Class I device that is upscaled to IIa (when passing from MDD to MDR) can be on the market until 2024 if it has a DoC (under the MDD) and doesn't have significant changes on the intended purpose, follows market and PMS, vigilance, registers EOs as for the MDR.

My question is: the application of DoC for these devices is May 2020 or May 2021? Thanks in advance!
 
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#2
it's May 2021. See below. More details in Erik's blog if you're interested: MDR amendment proposal article 120 (3) oversight set to be fixed by Council

Article 1 6) (aa)Article 120 is amended as follows:

paragraph 3 is replaced by the following:

“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 2021 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 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.,”
 
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