FAGG, Belgium: Medical devices and their accessories
MedLog provides FAGG registration and updates
The three previous European medical device directives were replaced by two regulations(link is external):
- Regulation 2017/745(link is external) on medical devices;
- Regulation 2017/746(link is external) on in vitro diagnostic medical devices.
These regulations did not have to be transposed into national law to be applicable. However, the regulations do provide that some measures can be taken through national legislation to implement the regulations.
For medical devices, this was done through the law of December 22, 2020(link is external), along with the following implementing decrees:
- Royal Decree of April 28, 2021(link is external) - Royal Decree amending and repealing various provisions on medical devices;
- Royal Decree May 12, 2021(link is external) - Royal Decree implementing the law of December 22, 2020 on medical devices;
- Royal Decree May 18, 2021(link is external) - Royal Decree on the clinical investigation of medical devices.
For in vitro diagnostic medical devices, this was done through the law of June 15, 2022(link is external), along with the following implementing decrees:
- Royal Decree of September 13, 2022(link is external) - Royal Decree amending and repealing various provisions relating to in vitro diagnostic medical devices;
- Royal Decree of September 14, 2022(link is external) - Royal Decree implementing the law of June 15, 2022 on in vitro diagnostic medical devices;
- Royal Decree of September 25, 2022(link is external) - Royal Decree on performance studies of in vitro diagnostic medical devices.