NLMedicalDevices object

National Act on Medicinal Products and Medical Devices
Transposition of EU Directives on MD
Other

Clinical trials on MD for human use are covered by:
The Law of 7 May 2004 relating to experiments on human people (Loi relative aux expérimentations sur la
personne humaine).
This law applies to all experiments on humans including Medicinal Products and Medical Devices. The general provisions have to be followed for all clinical research.
Please note thate there are some articles that are only relevant for clinical trials on Medicinal Products.

Royal Decree of 15 July 1997 implementing EU Directive 90/385/EEC (active implantable medical devices) modified by the Royal Decree of 10 December 2002 & the Royal Decree of 21 January 2009

Royal Decree of 18 March 1999 implementing EU Directive 93/42/EEC (medical devices) modified by the
Royal Decree of 17 March 2009

Royal Decree of 14 November 2001 implementing EU Directive 98/79/EC (in vitro diagnostic medical devices)
modified by the Royal Decree of 05 November 2012;

Royal Decree of 1 March 2000 establishing the remunerations to finance the missions of the administration regarding medical devices amended by the Royal Decree dated 13th May 2005.