1. Legislation
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Annex IX, Sections 5.2, 5.3.1, 5.4
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, Annex IX, Section 5.2
- Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin, Article 5
- The Act of 20 July 2006 on the establishment and operation of the Federal Agency for Medicines and Health Products, Article 4/2, §§1 and 2;
- Royal Decree of 12 May 2024 relating to scientific and technical advice on health products and advice relating to the status and classification of a product.
2. Guidance documents
- Regulatory guidance notice on the request for a consultation procedure for a notified body concerning a medical device incorporating a medicinal substance as an accessory.
- The guidance documents for the other consultation procedures will be made available during 2025.