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Aspects of the Authorized
Representative
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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.
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The Authorized Representative must meet all relevant deadlines. Failure to adhere to them carries
painful penalties.
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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
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The Authorized Representative requires the the 'Person' is capable to make qualified pre-submission
judgement (in the event of an incident) on behalf of
the manufacturer.
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The Authorized Representative should be in a position to ensure that he provides qualified and trained
(Regulatory Affairs) personnel to cover the responsibilities entailed.
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The Authorized Representative ought to have sufficient of individual Member State requirements.
(wherever applicable)
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Appointing a distributor could lead to a system of hierarchy to evolve between Distributors; those
not chosen may perceive themselves a being second class.
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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!
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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.
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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.
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Appointing a distributor requires that he must remain neutral in all actions and responsibilities,
especially toward 'rival' Distributors.
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Appointing a distributor may require him to make decisions that are contrary to international sales
objectives. This can potentially be hazardous.
FOR MORE INFORMATION, READ THIS ABSTRACT:
The Importance of being Authorized
(reprinted from Medical Device Technology 4/96)
To Download the entire MDD 92/43 EEC
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