Overview of the Health and Youth Care Inspectorate (IGJ) - Netherlands

Role of the Health and Youth Care Inspectorate (IGJ)

The Health and Youth Care Inspectorate (IGJ), part of the Ministry of Health, Welfare and Sport, is the Dutch authority responsible for supervising the safety and quality of medical technology, including medical devices and in vitro diagnostics (IVDs).

Key Responsibilities

1. Supervision and Enforcement: The IGJ monitors whether manufacturers, authorized representatives, importers, and distributors comply with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
2. Vigilance (Incident Reporting): IGJ receives and evaluates reports of serious incidents involving medical devices to prevent recurrence and ensure patient safety.
3. Market Surveillance: It conducts inspections and investigations to ensure that only safe and effective devices are available on the Dutch market.
4. Post-Market Surveillance (PMS): IGJ emphasizes the duty of manufacturers to actively monitor their products' performance after they have been placed on the market.
5. International Cooperation: Working with other EU competent authorities and the European Commission to harmonize medical device oversight.

Regulatory Framework

In the Netherlands, the IGJ enforces the rules set by European legislation (MDR/IVDR) as implemented into Dutch law via the Medical Devices Act (Wet medische hulpmiddelen).