Belgium – Publication of Law on Medical Devices

• 18/01/2021
• Articles

The Belgian Official Journal publishes today (i.e., 18 January 2021) the Law of 22 December 2020 on medical devices (Wet van 22 december 2020 betreffende medische hulpmiddelen / Loi du 22 décembre 2020 relative aux dispositifs médicaux – the Law). The Law implements in Belgium (i) Regulation (EU) 2017/745 of 5 April 2017 on medical devices (the MDR); and (ii) chapter IV of Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices, i.e., the chapter on notified bodies.
 
Following its adoption by the federal Chamber of Representatives’ Committee for Public Health and Equal Opportunities on 8 December 2020, the Law was adopted in plenary session on 17 December 2020. The adopted text is identical to that of the Bill which the federal Government submitted to the Chamber of Representatives on 29 September 2020.
 
For a discussion of the Law, we refer to our news alert of 3 December 2020 (see, Van Bael & Bellis Life Sciences News Alert of 3 December 2020).
 
Subject to exceptions, the Law will enter into force on 26 May 2021, i.e., on the currently scheduled date of entry into force of the MDR.