Authorized Representative Services

Warning - For risk class I devices!

Products, which stay class I under the MDR, must be in full compliance by May 26 2020!

  1. MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true.

  2. MDSS concern: Clients who have class I devices and higher risk class devices were also under the impression that their risk class I devices are also covered by the EC certificate for the higher risk class devices. This is not true. Please check in particular the accessories.

  3. MDSS concern: Clients who mainly have In Vitro Diagnostic Medical Devices, were under the impression that their medical devices as well fall under the application date of the IVD Regulation. This is not true.

Conclusion: All risk class I devices (MDD/MDR) must comply by May 26. 2020!

This means the EC REP contract must be fully executed and the EC REP must have performed the tasks outlined in the Mandate for the risk class I devices by May 26. 2020! Otherwise the products cannot be sold in Europe.

Add Comment

* Required information
Captcha Image
Powered by Commentics


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

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

    +44 7898 375115

  • U.S. Agent

    IL 60630

    +1 (312) 975-1694

  • Cosmetics Responsible Person

    Schiffgraben 41
    30175 Hannover

    +49 511 6262 8630

  • CH-REP

    Laurenzenvorstadt 61
    5000 Aarau

  • Importer

    Limmerstraße 15
    30451 Hannover

    +49 511 62 62 86 30


Schiffgraben 41
30175 Hannover


Stay informed