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Second Corrigendum to the MDR and IVDR

This update gives certain Class I manufacturer a break.  



On December 27 the second corrigendum was published in the official Journal of the EU. This update was indeed needed, otherwise with the lack of notified bodies (NB) the European health care system would have fallen apart. This update is a great relief for everyone. Certainly in particular for manufacturers who are directly affected by this. Here is the wording which does the magic:


On page  89, Article 120(3):
for:
‘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 …’,
read:
‘3.   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 …’.

In other words: All products of risk class I according to the MDD, which will have to be reclassified under the MDR to higher risk class and all risk class I reusable surgical instruments which stay class I but will need to involve a NB according to the MDR can be placed on the market until 2024 with complying to the MDD. A certification is not needed until then! However, please keep in mind that certain aspects of the MDR must be implemented. For example the vigilance according to the MDR. Please refer to the details of the MDR Article 120!



WARNING:
All other risk class I products must comply to the MDR by May 2020!! How funny!  The products with the lowest risk portfolio need to comply to the most stringent regulation first!! This update should have allowed those products as well for the extension. Laws sometimes take an interesting direction.


Just one detail to this corrigendum. It actually changes the regulation and this should not be possible via a corrigendum. A corrigendum normally crosses the ts and adds the dots.  There are other minor changes, which we have not reviewed. All the changes need to be assessed by the manufacturer to verify that this does not have an impact on you. The first corrigendum as well provided for some surprises and in fact impacted the requirements significantly. Someone could argue that those were not only Ts and dots.



Certainly as soon the consolidated version is available it is recommended to update your library.

Corrigendum to Regulation (EU) 2017:745.pdf

Corrigendum to Regulation (EU) 2017:746.pdf

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