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EU MDR deadline/transition!

Is Europe preventing the Chaos and getting back to Order with this extension proposal?

The outcome of last Friday's, December 9, 2022, EPSCO meeting was that, indeed, the transition period of legacy products is going to be extended!

  • Until 2027 for risk class IIb and III
  • Until 2028 for risk class IIa and class I up-classified

Additionally, there was the removal of the sell-off period. However, this might not help Manufacturers located outside the EU, since the Importer is the one placing the product on the market. Further clarifications may be needed from the Commission.

Among others, the extension was announced in this paper. The member states had a chance to express their views on the topic and there was, in fact, great support. If you are interested, you can watch here EU law making in progress. 

The details still need to be provided and the proposal must go through the legal process before implementation.

Unfortunately, details are yet to follow and the big question to be answered now is: from which date are legacy products being included? It could be that certificates which have expired are as well honored. However, there might be a cut-off date which does not include your certificate.

Therefore, the outline is to follow Article 97!

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