European regulations for medical devices and IVDs

New European rules for medical devices (MDR) and in vitro diagnostic medical devices (IVDs) became applicable in 2021 and 2022. The aim of the new rules is to improve patient safety and also to ensure that innovative medical devices remain available for the patient. This involves major changes.

Regulations for medical devices

The European regulation for medical devices (Medical Device Regulation, MDR) became applicable on 26 May 2021. The MDR replaces the earlier European Directives for medical devices (93/42/EEC) and for active implantable medical devices (90/385/EEC).

The European regulation for in vitro diagnostics (IVDR) became applicable on 26 May 2022. The IVDR replaces the earlier EU Directive on in vitro diagnostic medical devices (98/79/EC).

The European regulations have direct effect in all European Member States. The old directives were directed at the Member States and were incorporated into national legislation, i.e. the Medical Devices Act and the underlying Decrees under national legislation in the Netherlands.

Please also see Regulatory Framework

The regulations establish more stringent requirements for manufacturers, distributors, importers, European authorised representatives, notified bodies and healthcare institutions. These stricter requirements also entail a crucial expansion of the supervisory remit of the Health and Youth Care Inspectorate. The supervision of the Inspectorate focuses on the reduction of the risks of medical devices and IVDs and the application thereof for patients. The Inspectorate has adapted its supervision and its intervention policy to the European regulations, to which end the MDR the MDR/IVDR intervention policy (in Dutch) was drawn up.

More information

Please find more information about the European regulations and the effects of those regulations on rijksoverheid.nl: New legislation for medical devices (in Dutch). This website lists the consequences for manufacturers, distributors, importers, authorised representatives and health institutions.