Having received the Notified Body certificates, the manufacturer is able to finalise the EU Declaration of Conformity (Annex IV, 8) and the registration of the device (Annex VI, 2.2).
Manufacturers located outside of the must provide their Authorised Representative with the Technical Documentation, the Notified Body certificates and confirmation of the manufacturers registration. This information will enable the Authorised Representative also to register (Article 11).
Manufacturers located outside of the must also provide their Importer with the EU Declaration of Conformity, confirmation of the registration and the device labelling. This information will enable the Importer to register (Article 13).
Initial distributors in the supply chain will require their national language versions of the EU Declaration of Conformity and the packaging and instructions, including the Importer’s name and address if applicable, and the UDI number (Article 14).
If the manufacturer has a website, the national language versions of the packaging and instructions must be published there also (Annex I, 20.1.)
The device can now be imported, marketed, distributed, supplied for use and used within the EU.
Deliverables for demonstrating compliance:
(1) The finalised EU Declaration of Conformity, including versions in the language(s) of the countries where the device will be distributed,
(2) The finalised registration by the manufacturer,
(3) The registrations by the Authorised Representative and Importer (if applicable),
(4) The national language versions of the packaging and instructions available for Distributors.
(5) The national language versions of the packaging and instructions published on the Manufacturer's website.
Guidance
Guidance is also available from the Medical Device Coordination Group;
- MDR/IVDR Language requirements Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country.