Home
About MDSS
Newsletters
MDD
IVDD
AIMDD
Consulting & Support Services
Events
WWW Links
Contact MDSS

ABOUT MDSS
About MDSS
Management &  Personell
Authorized Representative

MDSS
serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individually.

Selecting a European Authorized Representative

When selecting your European Authorized Representative, it is essential to understand that there is more to  this important decision making process than may, at first, meet the eye.   

There are:

• The Legal Aspects
• The Safety Aspects
• The potential risk(s) involved, when appointing a Distributor

What exactly is an EU 'Authorized Representative' ?

1. The EU Authorized Representative is given the responsibility for maintaining the medical device manufacturers Quality Management System in the European Union.
2. The EU Authorized Representative is the legal interface, between the EU Authorities and the non-European medical device manufacturer.
3. The EU Authorized Representative is responsible for Medical Device Reporting (MDRs) The EU Authorized Representative must be available to the Competent Authorities (in charge of market surveillance) AT ALL TIMES, particularly in emergencies i.e. 365 days a year, (including holidays etc.)
4. The EU Authorized Representative MUST be reflected on either the manufacturers product labeling, outer packaging and/or instructions for use. Can be called upon, (by the manufacturer), to initiate procedures for:
   • EC Type Examination.
   • EC Verification.
   • EC Declaration of Conformity (Class I and Class IIa Devices).

CONSEQUENTLY, ALL TASKS AND RESPONSIBILITIES MUST BE AGREED UPON IN WRITING. The duties and responsibilities of those representatives should be clearly understood by medical device manufacturers and prospective Authorized Representatives PRIOR to any designation contract being signed or agreed upon.

It was for precisely these reasons, that MDSS was created. Because of our long-standing experience within the medical device manufacturing industry, we recognized that manufacturers would have the greatest difficulties in finding a suitable ‘Authorized Representative’ - one that would match the criteria and over and above that, have sufficient qualifications in Regulatory Affairs to be able to provide this demanding and highly ‘responsible’ type of service!

CONCLUSION: Manufacturers should be careful to designate only those Authorized Representatives who are qualified to represent the manufacturer’s interests in the EEA regarding the EU Directives.

Return To Previous Page