Authorized Representative Services

For risk class I manufacturer!

Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020.

Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf - December 2019. It was recently published and is great outline of what needs to be done specifically for risk class I products (see also News & Views 2019.12.19). We guess we can call this THE EIGHT STEPS TO CLASS I CE MARK.



Indeed it does extract the important aspects and should get you in compliance quickly.

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