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 EU 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, 23.1.)
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.
Are there strict requirements to follow for the process of translating the instructions for use into EU languages?
Like most procedures within the manufacturer’s quality management system, it is for the manufacturer to decide the actual practice. That said, providing translations is not new, so the manufacturer can expect their notified body to have expectations; is the source text the one they approved? How can the manufacturer be sure of the accuracy and suitability of the translations? How does the manufacturer respond to complaints or reports of inaccurate translations? etc. If the manufacturer doesn’t have internal capabilities, there are many companies offering this as a sub-contracted service.
Do third countries need to have an EU importer as well as AR for their medical devices, even if they are software?
Yes, software also. There is no difference. While such specifics are not specified in the regulation, industry practice is for the authorised representative and importer to be identified in the About box, start-up screen or similar user interface.