Authorized Representative Services

Grace Period offered for products who lose the notified body without fault!

Guidance was always in place in the EU for a Grace Period (GP). However, it is always up to the member states (MS) to follow a guidance. The MHRA has applied GPs but commits itself now with a solid process. Other countries have given GPs. Among them Germany, Switzerland, etc.


MDSS as the EC REP has applied on behalf of a client with its Competent Authority (CA). This allowed the client to sell his products without a NB certificate for a defined period. For manufacturers outside the EU it is important to know that the relevant authority is the authority of the EC REP - not the authority of the NB. It is not a trivial process and requires some negotiation skills!


With the conditions, it is an individual process, which also takes resources away from the MDR implementation. The good news is that you will be able to sell the product EU wide.


Contrary to this, article 59 MDR or article 11 (13) MDD allows MS to permit the selling restricted to their territory.


The big questions is what happens in terms of the Brexit.  The MHRA GP may only last until the end of 2020 if there is not a trade agreement covering this aspect.  

Here the MHRA reference.

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  • 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

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