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Authorized Representative means any natural or legal person established in the Community who is explicitly designated by the manufacturer. The Authorized Representative may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the manufacturer’s obligations under Directives: MDD-93/42/EEC Article 1.2.(j) and IVDD 98/79/EEC Article 1.2.(g)).

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The Official Languages of the EU are:

CS - Czech
DA - Danish
DE - German
EL - Greek
EN - English
ES - Spanish
ET - Estonian
FI - Finnish
FR - French
HU - Hungarian
IT - Italian
LT - Lithuanian
LV - Latvian
MT - Maltese
NL - Dutch
PL - Polish
PT - Portuguese
SK - Slovak
SL - Slovene
SV - Swedish

It is often commercially prudent to have other regional languages.

National "Custom and Practice" may be to include a non-EU language if it is widely spoken.

Legal and Administrative Requirement:

  • The Authorized Representative must be included on the product labeling
  • The Authorized Representative must hold or have ready access to the manufacturer’s technical file and/or design dossier
  • The Authorized Representative is responsible towards European Governments, representing the manufacturer in all European Regulatory Affairs
  • The Authorized Representative is obliged to submit Adverse Incident Reports (AIRs) and Medical Device Reports (MDRs)
  • The Authorized Representative must be appointed in writing, by contract
  • The Authorized Representative must be reflected in the manufacturer's Quality Management system
  • The Authorized Representative must be included in the manufacturer's product liability insurance policy.
  • The Authorized Representative must at all times be available to interact between the manufacturer, the European Authorities and the notified body
  • The Authorized Representative is an external part of the manufacturer's Quality System - possibly the most vulnerable element

Safety Requirements:

  • The Authorized Representative must meet all relevant deadlines. Failure to adhere to them carries penalties
  • The Authorized Representative requires qualified staff i.e. some Member States have regulations over and above those required by Directive e.g. Safety Officer (for Germany) who must have a University Degree and a minimum 2 years Medical Device experience
  • The Authorized Representative requires must make qualified pre-submission judgment (in the event of an incident) on behalf of the manufacturer
  • The Authorized Representative should be in a position to ensure that he provides qualified and trained (Regulatory Affairs) personnel to cover the responsibilities entailed
  • The Authorized Representative ought to have sufficient of individual Member State requirements. (wherever applicable)
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Uploaded March 14, 2005 - Last updated January 19, 2016
MeddiQuest Limited: Incorporated in England under number 4226188 at Quest Science PE2 5XS