Legislation

 

The three previous European directives on medical devices were replaced by two regulations:

These regulations did not have to be transposed into national law to be applicable. However, the regulations do provide that some measures can be taken by national legislation in order to implement the regulations.

For medical devices, this was done by the Law of December 22, 2020, together with the following implementing acts:


For in vitro diagnostic medical devices, this was done by the Law of June 15, 2022, along with the following implementing acts:

Which regulation replaces which directive?

Regulation (EU) 2017/745 on medical devices replaces:

  • Directive 90/385/EC on active implantable medical devices, transposed into Belgian law by the Royal Decree of July 15, 1997;
  • Directive 93/42/EC on medical devices, transposed into Belgian law by the Royal Decree of March 18, 1999.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices replaces:

  • Directive 98/79/EC on in vitro diagnostic medical devices, transposed into Belgian law by the Royal Decree of November 14, 2001.

Also other regulations cover medical device activities:

 

Last updated on 30/06/2023