Medical devices and in vitro diagnostic medical devices (IVDs) must comply with strict safety and performance requirements. These rules aim to improve patient safety while also ensuring that innovative medical devices remain available to patients.
Regulations for medical devices and in vitro diagnostic medical devices
The European regulation for medical devices ((EU) 2017/745 Medical Device Regulation, MDR) has been applicable since 26 May 2021. The MDR replaces the previous European Directives on medical devices (93/42/EEC, MDD) and active implantable medical devices (90/385/EEC, AIMDD).
Since 26 May 2022, the European regulation for in vitro diagnostics ((EU) 2017/746, IVDR) has also applied. The IVDR replaces the previous European Directive on in vitro diagnostic medical devices (98/79/EC, IVDD).
The European regulations apply in all European Member States. Only a limited number of additional matters, such as supervision and requirements relating to the language of the instructions for use, are governed by national legislation. In the Netherlands, this is laid down in the Medical Devices Act, the Medical Devices Decree and the Medical Devices Regulation.
See also Regulatory Framework
Impact on economic operators and the IGJ
The European regulations impose requirements on the various economic operators. These include manufacturers, distributors, importers, authorised representatives established in the European Union, notified bodies, and healthcare institutions that manufacture devices themselves, for example through in-house manufacturing. The requirements also give rise to supervisory responsibilities for the Health and Youth Care Inspectorate (IGJ). Supervision focuses on reducing the risks associated with medical devices and IVDs and their use for patients. The supervision carried out by the IGJ aligns with the European regulations. To support this, the MDR/IVDR intervention policy (in Dutch) has been established.
Transitional periods
Under certain conditions, manufacturers may still place some medical devices and IVDs on the market under the old Directives. These devices are referred to as ‘legacy devices’.
- See also transitional periods MDR and IVDR