August 7th 2017, the amendment to the Royal Decree of 14 November 2001 regarding In Vitro Diagnostic Medical Devices (Belgian transposition of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices) was published. The amendment entered into force August 17th 2017.
This amendment introduces a change in designated Competent Authority in Belgium. Responsibility shifted from the Scientific Institute for Public Health – l’Institut scientifique de santé publique (WIV/ISP), service Quality of medical laboratories to either:
- The Federal Agency for Medicines and Health Products (famhp) that is authorised to control, in particular:
- Reagents, reactive products, calibration and control materials and kits except for those containing substances that emit ionizing radiation.
- General laboratory products that are specifically intended by the manufacturer for use in in vitro diagnostics.
- Software specifically used for the clinical interpretation of results obtained with one or more in vitro diagnostics
- Apparatus, equipment, measuring devices and systems including the software required for its proper functioning, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.
- The Federal Agency for Nuclear Control (FANC) that is authorized to control, in particular:
- Devices, equipment, measuring devices and systems considered as being an in vitro diagnostic medical device which emit or measure ionizing radiation.
- Reagents, reactive products, calibration and control materials and kits containing substances that emit ionizing radiation.
A new notification form (only in Flemish and French), has now been made available on the website of the famhp (link in Flemish).
We draw your attention to the specific clause regarding the languages required for the Instructions For Use (IFU) and Labels to be provided upon notification. This clause explicitly states the requirement to provide IFUs and Labels in all three official Belgian country languages (FR, NL, DE). If these cannot be provided then, if the product is intended for lay persons a declaration must be provided that the products will not be placed on the Belgian market, if the product is intended for professional users either a declaration that the products will not be placed on the Belgian market or a declaration that a signed agreement with the end user will be established for providing the IFUs and Labels in another official member state language, must be provided.