The Royal Decree of 15 November 2017 on the notification of a materialovigilance contact point within hospitals and the registration of distributors of medical devices was published on 7 December 2017. This Royal Decree, which has been in force since 17 December 2017, describes the new provisions of the legislation for distributors in the medical devices sector. In accordance with Article 4 of this Royal Decree, distributors of medical devices are required to register on the FAMHP web portal .
Distributors must not register on Eudamed.
Importers can register on Eudamed in the "actors" module. This registration is voluntary. The legal obligation to register on Eudamed will become effective 6 months after Eudamed is fully functional. The FAMHP strongly encourages importers to register proactively today. In fact, Eudamed will be considered as the authentic source for the "actor" data of economic operators (manufacturers, authorised representatives and importers), and our online applications (the web portal) communicate with Eudamed in order to retrieve this data. This means that registration on Eudamed will be considered as registration on our online applications.
Device relabelling and repackaging
Importers and distributors carrying out at least one of the activities referred to in Article 16, §2 points a) and b) of the Regulation 2017/745 or Regulation 2017/746 concerning the relabelling and repackaging of devices and intending to make these devices available on the Belgian market must inform the FAMHP.
The distributor or importer must sends the FAMHP a certificate issued by a notified body designated for the type of device being repackaged/relabelled within twenty-eight days. This certificate attests that the distributor's or importer's quality management system complies with the requirements of Article 16(3) of applicable regulation (Regulation 2017/745 or Regulation 2017/746).
This certificate must be sent to us via our web portal in the « my activities » section for the importer’s or distributor’s activity.
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