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MDR Delay - MDD design Change? (before new MDR DOA)

Sammy23

Starting to get Involved
#1
With the MDR delayed until May 2021, are able to make a design change to our MDD compliant device? We have a design change project, where all V&V and necessary documentation will be completed by May 2020. Based on Article 120 (3), since the DOA is now May 2021, can we make this design change? Is Article 120(3) saying that we can make design changes to MDD compliant devices prior to the DOA?

Article 120(3)

"By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation 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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Asia78

Involved In Discussions
#7
Yes, you can make significant changes to mdd devices until may 2021.
The new DoA implies also the postponment of all the applicable requirements.
The published MDCG guidances are still valid in their content, but the dates written may be wrong being that they were published before the latest changes to the Mdr
 

Philip B

Involved In Discussions
#8
BSi stopped clients making significant changes to their MDD certificates last year as there would not have been enough time to implement these before May 2020. Not sure what their stance is now the MDR has been put back a year? Best to check with your NB.
 
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