MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...
    more


    
HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION 
– THE MDR/IVDR!!!

more...


In-House Workshops
"The NEW CE MARKING"
Book now
 to make sure you’re ready to survive and thrive!


Keep up to date!

Cosmetic Products in Europe

Latest News



EVENTS
Meet us!

MEDICA
November 18-21, 2019
Dusseldorf, Germany
Booth #10B05





CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





Representative for Medical Device Safety – new requirements for operators


On the 1st of January, 2017 the new version of the “Regulations governing the installation, operation and use of medical devices(MPBetreibV) entered into force.
Now the completely revised version explicitly defines, according to §6, a "representative for Medical Device Safety", who is to be designated in healthcare facilities with a regular workforce from 20 people onwards.

The Representative for Medical Device Safety assumes for the operator of the facility a coordinating position between authorities, manufacturers, distributors, users, operators as well as internal employees and must possess an appropriate qualification.

MDSS Consulting GmbH  has qualified employees who can take over this central role and fulfil, as external service provider, the following duties  for a healthcare facility:
  • Contact for authorities, manufacturers and distributors in connection with notifications of medical devices risks.
  • Coordination of internal processes to fulfil the obligations of notification applying to  users and operators
  • Coordination of corrective actions and recalls

Avoid criminal offences as per §42 Section 2 No. 16 of the MPG (German Medical Device Act ).

We support you as a Representative for Medical Device Safety and advise you in all questions about the MPBetrV. For further information, please use our contact form.