Medical devices: autocontrol and administrative simplification. End of the transition period on 17th June 2018.

As a result of the changes in the legislation on medical devices, the FAMHP has set up a web portal in order to facilitate registration. The transition period ends on 17th June 2018. From then on, all the operators that fail to register will no longer be able to legally carry out their activities.

On 7 December 2017, the Royal Decree of 15 November 2017 concerning the notification of a materiovigilance point of contact and the registration of medical device distributors and exporters was published. This Royal Decree, in force since 17 December 2017, describes the new provisions of the legislation for operators in the medical devices sector. These operators are invited to register with the FAMHP (only available in French and Dutch). The transition period ends on 17th June 2018. From then on, all the operators that fail to register will no longer be able to legally carry out their activities.

This Royal Decree also defines new market oversight procedures for medical devices.

Furthermore, a new registration procedure has been implemented for all operators in the sector, based on the “only once” principle of administrative simplification, which provides that a citizen only has to provide the authorities with the same information once.

For the authorities, this principle implies gathering a maximum of information already known to other authorities/bodies, such as the data encoded in the Crossroads Bank for Enterprises (CBE) or in the European VAT number database(VIES), pending launch of the European MDR-Eudamed database.

In practice
A new web portal including four applications has been made available.

  • My enterprise: an application covering general information on the business.
  • My activity: an application covering activities such as manufacturing, distribution, exportation … but also the risk classes of the medical devices concerned (class I, IIa, IVD list A, IVD list B …).
  • My control: an application covering forms (used for risk analysis) and offering a platform for communication relating to the inspections performed by our inspection services.
  • My address book: an application used by distributors to provide information on the names of the manufacturers and authorised representatives of the devices that they distribute.

More information
FAQ

Last updated on
03/04/2018