European regulations for medical devices and IVDs
There are new European rules for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). 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 new European regulation for medical devices (Medical Device Regulation, MDR) has come into effect 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).
Subsequently the new European regulation for in vitro diagnostics (IVDR) will be coming into effect on 26 May 2022. The IVDR will replace the existing EU Directive on in vitro diagnostic medical devices (98/79/EC).
These directives were fformerly implemented into the (national) Medical Devices Act [Wet op de medische hulpmiddelen] and the underlying Decrees. The new European regulations are direct legislative in all European member states.
The new legislation imposes stricter requirements on manufacturers, distributers, importers, European authorised representatives and health institutions. The more stringent requirements also mean a significant expansion of supervisory tasks for the Health and Youth Care Inspectorate (IGJ). The IGJ's supervision focuses on reducing the risks of medical devices and their use for patients. IGJ will synchronize its supervising activities to the new legislation and keep you informed by this web page.
You can find more information on the new regulations and their consequences at rijksoverheid.nl: New legislation for medical devices (in Dutch).
This website lists the consequences for manufacturers, distributors, importers, authorised representatives and health institutions.
You can also find more information in these guidelines: Guide to the new European Regulations for medical devices and IVDs (in Dutch).