European Union Authorised Representative
New regulatory requirements under the Medical Device Regulation (MDR)
Under the European Directive for Medical Devices (EU 2017/745), a manufacturer of a device, which is not established in a member State of the European Union, has to appoint an authorized representative in the Union in order to comply with the directive.
This European Authorized Representative represents your business for European Union Regulatory Authorities and the local competent authority. This role is defined in article 11 of the European 2017/745.
Extract of Article 11, tasks of the EU Authorised Representative
EU Authorized Representative under the MDR
Exportia France SAS, based in Paris and its legal representative Christelle Damiens offers an independent European Authorized Representative service for non-Europe based medical device companies.
Advantages of using the services of Exportia as your Authorised Representative:
In France
At the heart of a major European Medical Device market, France, Exportia is well positioned
- to respond to the local authority requests in an efficient manner
- to communicate, if required, with European distributors and customers, team of PRRCs are French natives
An Independent Representative
Of course, you can choose to give this mandate to your distributor or your importer, but some of the advantages of having in an independent EU-Authorized Representative are:
- our focus will be 100% oriented on the manufacturer’s needs and the competent authorities requests, without any commercial interests interfering
- it gives the freedom to the manufacturer to shift and change its distribution strategy while leaving the role and responsibilities of the European Authorized Representative undisturbed.
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