Legislation

Legislation

Three important European directives govern the various types of medical devices. These directives were converted to Belgian law.

• Directive 90/385/EEC governing the active implantable medical devices, converted to Belgian law by the Royal Decree dated July 15, 1997 governing the active implantable medical devices.
• Directive 93/42/EEC governing medical devices, converted to Belgian law by the Royal Decree dated 18 March, 1999 governing medical devices.
• Directive 98/79/EEC governing medical devices for in-vitro diagnostics, converted to Belgian law by the Royal Decree dated November 14, 2001 governing medical devices for in-vitro diagnostics.

Other legislation also apply to activities in association with medical devices.

• The Act dated 20 July 2006 – concerning the establishment and operation of the Federal Agency for Medicines and Health Products.
• The Act dated 11 March 2018 – concerning the financing of the Federal Agency for Medicines and Health Products.
• The Act dated 15 December 2013 – concerning medical devices.
• The Royal Decree dated 15 November 2017 – Royal Decree concerning the notification of a contact point for materiovigilance and the registration off the distributors and exporters of medical devices.
• The Act dated 25 March 1964 – medicinal products act.

Authority of the FAMHP

Each member state designates the competent authorities for each directive concerning the various types of medical devices. The Federal Agency for Medicines and Health Products is the competent authority in Belgium for the three aforementioned directives.

The Federal Agency for Nuclear Control is the competent authority for ionizing sources of medical devices.

Role of the competent authority

The primary tasks of the competent authority are the market oversight and the instruction, monitoring and re-evaluation of registered institutions (notified bodies) in Belgium.

Oversight by this authority includes:

• notification of bringing medical devices to market;
• notification of distributors and exporters;
• notification of clinical studies with medical devices performed on Belgian territory and of efficacy studies with medical devices for in-vitro diagnostics;
• the reporting incidents with medical devices occurring on Belgian territory and the corrective actions taken according to the safety regulations for the Belgian market;
• the notification of the oversight of notified bodies in Belgium;
• the enforcement of the legal regulations by all parties involved;
• implementation of inspections.

The experts of the FAMHP also take part in mutual evaluations of notified bodies (joint assessments) organized by the European Commission.