26 May 2019 - Authored by:Kaat Van Delm
On 7 April 2019, a law altering the notification procedure for implants and certain invasive medical devices for long-term use was adopted. Previously, the Belgian Sickness and Invalidity Institute (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. Once the new law enters into force, the FAMHP will oversee both these notification obligations to ensure continuity and proper co-ordination, with notifications being submitted via the web portal of the FAMHP. The FAMHP will, in addition, require 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. The new law will enter into force on 1 June 2019.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, May 2019 Issue (Thomson Reuters).