18 June 2019 - Authored by:Kaat Van Delm
On 1 June 2019, a new Royal Decree (dated 7 April 2019) altering the notification procedure for implants and certain invasive medical devices for long-term use entered into force. Previously, the Belgian Sickness and Invalidity Institute (RIZIV/INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical devices were required to register with the Federal Agency for Medicines and Health Products (FAMHP) pursuant to Article 4 of the Royal Decree of 15 November 2017.
Since 1 June, the FAMHP oversees both these notification obligations to ensure continuity and proper co-ordination, with notifications being submitted via the web portal of the FAMHP. The FAMHP, in addition, requires distributors to provide the European risk classification for the medical device. Notification of implants and certain invasive medical devices is a precondition for being eligible for reimbursement via mandatory healthcare insurance.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, May 2019 Issue (Thomson Reuters).