From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical product to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes.
The FAMHP would like to inform consumers and patients of a recall by Stöpler Medical B.V. concerning COCUNE brand mitt-type body wipes. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.
The European Commission is looking for experts for panels on medical devices and in-vitro diagnostics
Later this year, the European Commission will launch a call for experts in medical devices and devices for in-vitro diagnostics. They will form expert panels to provide advice and assess new risky devices.
Recommendations for paclitaxel-coated balloons and paclitaxel-eluting stents in the treatment of peripheral arterial disease
A scientific article has raised concerns about paclitaxel-coated balloons and paclitaxel-eluting stents used in the treatment of peripheral arterial disease (PAD). In response, the Federal Agency for Medicines and Health Products (FAMHP) hereby makes its recommendations.
Implants and certain invasive medical devices: as of June 3, 2019, the FAMHP takes over the RIZIV notification database.
Every company selling implants and certain invasive medical devices in Belgium must report the data for these in a notification database. The notification of these medical devices applies as a condition for reimbursement of the obligatory insurance for health care. From June 3, 2019 the notification of these medical devices in the database will occur via a new online application at the Federal Agency for Medicines and Health Products (FAMHP).