Authorized Representative Services

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!

Comment on youregulate.com...

Add Comment

* Required information
1000
Captcha Image
Powered by Commentics

Comments

No comments yet. Be the first!
  • UK Responsible Person

    6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK

    +44 7898 375115

  • U.S. Agent

    Chicago
    IL 60630
    USA

    +1 (312) 975-1694

  • Cosmetics Responsible Person

    Schiffgraben 41
    30175 Hannover
    Germany

    +49 511 6262 8630

  • CH-REP

    Laurenzenvorstadt 61
    5000 Aarau
    Switzerland

  • Importer

    Limmerstraße 15
    30451 Hannover
    Germany

    +49 511 62 62 86 30

MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

Share

Stay informed