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.
Some medical devices and IVDs may still be marketed under the old Directives under certain conditions. We call these devices “legacy devices”. The periods within which this is still permitted have been extended for both Regulations. This was arranged for the IVDR in January 2022 and for the MDR in March 2023. This means that these devices have more time to comply with the new rules and obtain a CE-certificate.
This also gives notified bodies more time to certify devices in order to allow them onto the market. This appeared not to be possible within the previously set deadlines. As a result, there was a risk for many medical devices of disappearing from the market. Consequently, that would also pose a risk to patient safety. The Regulation that postpones the transitional periods from the MDR only applies under certain conditions to medical devices that are sufficiently safe.
Transitional periods MDR
The end date of the extension depends on the risk class of the device:
Until 31 December 2027 for Class III medical devices and Class IIb implantable devices.
Certain devices for which the MDR provides exemptions are excluded. This is because the legislation considers these devices to be based on well-established technologies;
Until 31 December 2028 for devices from the other risk classes;
Custom-made class III medical devices may be placed on the market or put into service until 26 May 2026 without a certificate from a notified body;
Devices for which the involvement of a notified body was not required under the MDD, but is required under the MDR, and for which a declaration of conformity was drawn up before 26 May 2021, may be placed on the market or put into service until 31 December 2028.
The possibility to use the extended transitional periods only applies to certain medical devices and under the conditions as stated in regulation 2023/607.
Transitional periods IVDR
Be aware: the IGJ appeals to manufacturers to meet the IVDR requirements before the deadline. Read more in this publication.
The end date of the extension depends on the risk class of the IVD:
Until 26 May 2025, for class D devices;
Until 26 May 2026, for class C devices;
Until 26 May 2027, for class B devices;
Until 26 May 2027, for Class A devices placed on the market in a sterile condition.
- Questions and answers regarding the transitional provisions of the MDR
- Regulation regarding the transitional provisions of the IVDR
- Questions and answers regarding the transitional provisions of the IVDR
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.