On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more
As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices legislation has been significantly affected....more
On January 17, The Belgian Data Protection Authority (DPA) published Recommendation no 01/2020 providing Guidance on direct marketing. The Recommendation provides a methodology on how to comply with the General Data...more
3/6/2020
/ Belgium ,
Data Controller ,
Data Privacy ,
Data Protection ,
Data Protection Authority ,
Direct Marketing ,
EU ,
General Data Protection Regulation (GDPR) ,
Personal Data ,
Regulatory Requirements ,
Transparency
Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more
The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human...more
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....more
5/8/2018
/ Belgium ,
Data Protection ,
Disclosure Requirements ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Personal Data ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Standards ,
Sunshine Act