ROLE OF AN AUTHORISED REPRESENTATIVE

Manufacturers outside Europe must appoint an Authorised Representative or importer to fulfil some of the requirements of Directive 93/42/EEC before they CE mark.

1. Legal aspects

 The Authorised Representative’s name and address must be included on the product labelling and/or instructions for use.  This demonstrates the legal link between the Manufacturer and the Authorised Representative.

 The Authorised Representative is responsible for representing the Manufacturer to European Competent Authorities and for all European Regulatory Affairs.

 The Authorised Representative’s name and address should be included on the Manufacturer’s EC Declaration of Conformity.

 The Authorised Representative is obliged to submit Medical Device Vigilance Reports on behalf of the Manufacturer.  Failure to meet legal deadlines, or any other inconsistencies, may lead to legal sanctions, both for himself and the Manufacturer.

 The Authorised Representative, his appointment and duties must be specified contractually.

 The Authorised Representative is an external and vital part of the Manufacturer’s Quality System and should be referred to in the Manufacturers Quality Manual and Procedures.

 The Authorised Representative may face liability claims if his legal duties are not correctly carried out.

 The Authorised Representative needs to be included in the Manufacturer’s product liability insurance policy.

 The Authorised Representative must at all times be available to liase between the Manufacturer, the European Competent Authorities and the Notified Body of the Manufacturer.

2. Other obligations

 The Authorised Representative should understand the national Member State requirements (where applicable) in addition to the Directive requirements.

 The Authorised Representative should have sufficient qualified and trained staff to meet national requirements and to make initial decisions on behalf of the manufacturer.

3. Why appoint an Authorised Representative when a Distributor may do it free of charge?

 Appointing one distributor amongst many can lead to a hierarchy with others feeling dissatisfied.  Having to include the name and address of the appointed Distributor on labels and instructions for use is an advantage for him and a huge disadvantage for the other Distributors.

 It is sometimes difficult for a Distributor to remain neutral and he may take decisions that are contrary to the Manufacturers international sales objectives.

 Appointing a Distributor may eventually cost time and money should the Manufacturer wish to change the distributor.  Also products containing the original Distributor’s name will remain in the distribution chain for a long time.

 An appointed Distributor must have access to product files.  Remember this Distributor could be a future competitor!