Why must a non-EU manufacture of medical device appoint a European Authorized Representative?
The European Union’s ‘New Approach Directives’ are mandatory on all member countries to enact through national legislation. This legislation requires manufacturers to display Marking on their products, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) “an offense to place a product on the market without Marking”. The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying Marking. For medical devices, it is compulsory, under the 3 Medical Devices Directives, that the non-EU manufacturer must appoint an Authorized Representative (authorised representative) which must be established (have a registered business) in the European Union member states to act on manufacturer’s behalf in carrying out certain tasks including: • Dealing with the regulatory authority; • Keeping, for a period extending to at least five (5) years after manufacture of the product, the
Related Questions
- Which of the Authorized Representatives essential duties are listed in the Medical Device Directive and what should we ask for in addition?
- Why must a non-EU manufacture of medical device appoint a European Authorized Representative?
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