The Regulation defines economic operators as the manufacturer, the authorised representative, the importer and the distributor. The current Medical Device Directives do not regulate importers and distributors, so this is a completely new feature. The intention is to improve traceability of medical devices and to enhance market surveillance by giving a role to importers and distributors in the identification of and dealing with non-compliance and safety issues.
The requirements for authorised representatives are defined in more detail than before. These operators have to meet new criteria of competence and are now made liable for defective products. This is likely to lead to the disappearance of many authorised representatives and make their services more expensive.
The requirements for importers and distributors give them new responsibilities concerning market surveillance, corrective action and traceability. Although this will make identification of and dealing non-compliant products more effective, the somewhat overlapping nature of these requirements is also likely to lead to conflicts between all the economic operators.
Mika Reinikainen, Chairman EAAR; Managing Director, Abnovo Ltd, UK