New 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 ensure that innovative medical devices remain available for the patient. This involves major changes. You can read what this means for you in the guide at the bottom of this page.
The more stringent requirements also mean a significant expansion of supervisory tasks for the Health and Youth Care Inspectorate (IGJ). Our supervision focuses on reducing the risks of medical devices and their application for the patient. In the coming years, we will continue to restructure its supervision on this subject in response to the new legislation. We will keep you informed via this webpage.
New regulations for medical devices
On 25 May 2017, two new regulations for medical devices entered into force. In a number of years they will replace existing legislation in this area. These are European Directives for active implantable medical devices (90/385/EEC), medical devices (93/42/EEC) and in-vitro diagnostic medical devices (98/79/EC). These directives have been implemented into Dutch legislation in Decrees of the same name as part of the Medical Devices Act. See also the Regulatory Framework.
The new legislation will become applicable after a transition period. A three-year transition period (May 2020) applies for the medical devices regulation, while a five-year transition period (May 2022) applies for regulation on in-vitro diagnostic medical devices. Due to the international crisis surrounding COVID-19, the new legislation for the medical devices regulation will become applicable a year later, on May 2021. The regulations do not have to be transposed into Dutch law; they apply immediately throughout Europe. We will supervise compliance with the new rules based on risk-based supervision.
New designation of Notified Bodies
Partly as a result of Brexit, three notified bodies have to be reassigned in the Netherlands: BSI Group The Netherlands B.V., DARE!! Services B.V. en DEKRA Certification B.V.. These three notified bodies have submitted their applications and these applications are being processed.