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FAGG accession

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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):

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:

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: