The publication of the Annual Report of FAMHP (Federal Agency for medicines and health products) has been significantly delayed due to the COVID-19 pandemic, top priority of the Agency, and the impact of Brexit on the Agency’s Divisions.
The digital Annual Report 2019 contains interesting figures concerning medicines and medical devices, with the latter being the focus of this article.
Pre-authorization data
-> 40 Clinical investigationswith medical devices:
- 5 with active implantable medical devices;
- 4 with a class I medical device;
- 13 with a class IIa medical device;
- 4 with a class IIb medical device;
- 14 with a class III medical device.
-> Closure of 44 clinical investigation files, with 95% within the legal period.
-> 47 assessment reports for clinical trials.
Post-authorization data
Materiovigilance with 1000 reports received:
-> 2053 incidents;
-> 459 FSCA.
In 2019, the FAMHP identified an increase in the number of reported incidents with medical devices.
Inspections
-> 263 inspections of medical devices covering:
- 20 GCP of medical devices;
- 57 MD/IVD manufacturers;
- 6 registered bodies;
- 148 distributors, 38 as part of autocontrol identifying 115 deficiencies;
- 1 healthcare provider;
- 4 medical device advertising;
- 27 medical devices in hospitals.
-> The FAMHP can carry out inspections of medical devices manufacturers and their representatives established in Belgium, including custom-made devices and procedure packs manufacturers.
-> Advertising rules of medical devices are governed by general regulations on advertising, but also by specific legislation with the aim of promoting rational use of medicinal products and MD’s, in full objectivity and on the basis of correct and complete information (FAMHP, 2021).
3581 registered actors (manufacturers, legal representatives, distributors, importers).
Free Sales Certificates:
- 2042 for medical devices;
- 514 for in-vitro diagnostic medical devices;
Class I medical devices:
- 399 new Class I notifications;
- 138 amendments to the notification;
- 21 recalls.
Ajda Mihelcic
10.06.2021
DPM Publications dept.
Are you a Class I manufacturer or do you wish to expand to other markets on the basis of the CE marking? We can assist you in obtaining an FSC (Free Sales Certificate) and notifying your device to the FAMHP.
Contact us today!
References:
- FAMHP. (2021). Annual Report 2019. Retrieved on 10.06.2021 from Fagg – Fagg (fagg-afmps.be)