New rules for medical devices distributors and importers: registration, self-regulation and vigilance contact point

On 17 December 2017, a royal decree of 15 November 2017 “on the notification of a vigilance contact point and the registration of distributors and exporters of medical devices” (the Decree) entered into force. This short note addresses the key takeaways to consider.

Registration

The Decree makes it a legal obligation for (i) distributors established in Belgium and distributors established in the EU, which are making medical devices, in vitro diagnostic (IVD) medical devices and active implantable medical devices available in Belgium and (ii) anyone established in Belgium making such devices available for distribution and/or use outside the EU (exporters), to register their activities with the Federal Agency for Medicines and Health Products (FAMHP).

The registration must be made online, on a Generic Portal which has been developed by the FAMHP, before any distribution or exportation activities are carried out. Distributors and exporters are given a 6-month transition period as of 17 December 2017 to (i) confirm and complete their information if they have been previously registered on SADN/RADG or (ii) to register for the first time if they have not done so before the entry into force of the Decree.

For the time being, companies located outside the European Union, importing medical devices for distribution on the Belgian market, without a local presence in Belgium or in the EU, are not legally required to register, although manufacturers may choose to appoint their authorised representative to provide information on distribution activities through the Generic Portal.

Information to provide as part of the registration process includes the company’s data, the representative’s data, the types of devices distributed or exported, their classification (or relevant list for IVD medical devices), the manufacturer’s data, the contact person’s contact details, and the references of the person in charge of the vigilance contact point. All such information must be confirmed on a yearly basis and updated within 15 days should any change arise.

Pharmacists practicing in a pharmacy open to the public are excluded from the registration requirement when they deliver medical devices to patients.

Self-regulation

Any natural or legal person in the supply chain, other than the manufacturer or the importer that makes a device available on the EU market may choose to follow Guidelines, approved by the FAMHP, to ensure the quality of the medical devices which they distribute.

To submit a Guideline for review, any applicant must follow a set of criteria outlined in Annex I of the Decree. Guidelines must be bilingual. They are likely to cover a specific type of pathology and will be available online once approved by the FAMHP.

To comply with a Guideline, operators must declare their intention to comply to the FAMHP. While compliance with a Guideline is not mandatory (hence self-regulation), it will weigh in the risk-assessment made in the course of inspections’ preparation by the FAMHP’s DG Inspection/DG Inspection.

As part of a broader process towards digitalising inspection procedures followed by the FAMHP, an IT portal is being set up to enhance the exchange of information between the industry and authorities.

It is expected that the submission and approval of transparent Guidelines in line with the new Decree should facilitate both the inspection planning, and the identification and assessment of risks by the authorities, as well as the planning of and preparation for inspections by the operators.

Of note, this provision is a new step towards the adoption of Guidelines by companies responsible for installation, maintenance and removal of medical devices in the context of home-based care.

Vigilance contact point

Distributors making medical devices available in Belgium and hospitals in which medical devices are used are obliged, since 2015, to have a vigilance contact point in place in order to report incidents to the FAMHP. This contact point must be notified to FAHMP online via the Generic Portal.

While most of the provisions of the current regime have been left untouched by the Decree, the system has been slightly modified to (i) include registered pharmacists within public pharmacies and (ii) restrict the scope of the obligation to cover only “distributors established in Belgium” rather than “distributors making medical devices available in Belgium”.

The royal decree of 15 November 2017 on the notification of a vigilance contact point and the registration of distributors and exporters of medical devices has been published in the Belgian Official Gazette on 07 December 2017 and can be viewed online in French and Dutch.

This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.