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THE "NEW" CE MARKING
Get your questions answered for the NEW MD REGULATION – THE MDR!!!
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EVENTS
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MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



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9. Medical Device Networking Meeting -
a RAPS Roadshow 
November 30, 2017
Hannover, Germany

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10. Medical Device Networking Meeting - 
a RAPS Roadshow 
December 04, 2017
Ulm, Germany

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Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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Aspects of the Authorized Representative

The Legal Aspects of the Authorized Representative

  • The Authorized Representative must be included on the product labeling (and/or) instructions for use etc. He becomes (from a legal standpoint) intrinsically tied to the manufacturer.

  • The Authorized Representative is responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs.

  • The Authorized Representative is obliged to submit Medical Device Reports (MDRs) on behalf of the manufacturer. Failure to meet deadlines, or any other inconsistencies, may have serious repercussions, both for himself and the manufacturer.

  • The Authorized Representative must be appointed in writing, by contract; all duties and responsibilities ought to be clearly defined and assigned.

  • The Authorized Representative ought to be reflected in the manufacturer's Quality Management system

  • The Authorized Representative may face liability claims resulting either from product malfunction or serious complaint!

  • The Authorized Representative needs to 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 in the Quality Management system.

 
The Safety Aspects of the Authorized Representative

  • The Authorized Representative must meet all relevant deadlines. Failure to adhere to them carries painful 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 the 'Person' is capable to make qualified pre-submission judgement (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)
 
Why Appoint an "Authorized Representative" When my distributor offers to do it for free?


  • Appointing a distributor could lead to a system of hierarchy to evolve between distributors; those not chosen may perceive themselves a being second class.

  • Appointing a distributor may cost time and money, should the manufacturer wish to change this particular distributor at any future time. Products carrying this distributors name on labeling or instructions for use, will however, be in the market long after the distributors have changed!

  • Appointing a distributor allows one distributor to be included on all labeling (and/or) instructions for use - an advantage to him but a huge disadvantage for his fellow distributors.

  • An Appointed distributor must allow the Authorities to access the Product Master Files, when asked. In the hands of a possible competitor, this could have disastrous long term consequences.

  • Appointing a distributor requires that he must remain neutral in all actions and responsibilities, especially toward 'rival' distributors.

  • Appointing a distributor may require him to make decisions that are contrary to international sales objectives. This can potentially be hazardous.
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