Think about how your product will be distributed across Europe. Distributors have obligations, including checking that the devices they distribute comply with the regulation and reporting complaints and suspected serious incidents. Consider how will you provide your distributors with the information they need, and vice versa.

If yours is an enterprise which is not based in the EU there are additional steps:

You will need to appoint a legal representative within the EU to act on your behalf. According to Article 11 all foreign manufacturers must appoint an “Authorised Representative”. It can be a company or an individual. The role is primarily to act as your representative in front of the Authorities. You will need to decide the scope and mandate of your Authorised Representative (see Article 11, 2).

Consider appointing one specific “Importer”. Anyone who imports your product into the EU also has obligations (see Article 13) in addition to those of the Authorised Representative. Like Authorised Representatives, Importers must also register with the Authorities. Like Authorised Representatives the name and address of the importer must also be on or accompanying the product in the distribution chain. But Importers must also keep records of complaints and inform the authorities of reports of serious incidents involving the product. Importers have to work closely with Authorised Representatives. Therefore, it is worth considering whether the same legal entity could fulfil the roles of both Authorised Representative and Importer for your device.

Deliverables for demonstrating compliance:

(1) Agreements with an Authorised Representative, Importer(s) and/or Distributor(s) as applicable.

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