Medical devices (Royal Decree dated 18 March 1999) are subdivided into four classes (class I, IIa, IIb and III) which are consistent with the risk associated with their use. The classification rules are listed in annex IX of the Royal Decree dated 18 March 1999 regarding medical devices.

European classification guidelines are also available (part 1 and part 2).


For medical devices for in-vitro diagnostics there is classification according to annex II of the Royal Decree dated 14 November 2001.

Last updated on 31/03/2021