FAMHP: Belgium's Medical Device Regulatory Body

Overview of the FAMHP

The Federal Agency for Medicines and Health Products (FAMHP) is the competent authority in Belgium responsible for ensuring the quality, safety, and efficacy of medicines and health products (including medical devices and in vitro diagnostics) throughout their entire lifecycle.

Role and Responsibilities

1. Regulatory Framework: Implementing European Regulations such as the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) into Belgian national law.
2. Clinical Investigations: Authorizing and supervising clinical investigations for medical devices and performance studies for IVDs to ensure subject safety and data reliability.
3. Market Surveillance: Conducting inspections and audits of economic operators (manufacturers, importers, and distributors) and health institutions to verify compliance with safety and performance requirements.
4. Vigilance (Materiovigilance): Managing a national system for reporting and investigating incidents involving medical devices to prevent recurrence and protect public health.
5. Notifications and Registration: Handling the registration of economic operators and notifications of devices being placed on the Belgian market (managed via the national portal until EUDAMED is fully mandatory).
6. Notified Body Oversight: Cooperating with the European Commission to designate and monitor Belgian Notified Bodies responsible for conformity assessments.

Key Focus Areas

• Patient Safety: Ensuring that only devices meeting strict safety and performance standards reach users.
• Innovation Support: Providing guidance to researchers and industry on complex regulatory pathways.
• European Collaboration: Participating in the Medical Device Coordination Group (MDCG) at the EU level to harmonize standards across member states.