Article R5221-27 of the French Public Health Code
November 1, 2023
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examination certificate. The manufacturer must take all measures necessary to ensure that the manufacturing process guarantees conformity of the in vitro diagnostic medical devices manufactured with the type described in the EC type-examination certificate and with the essential requirements defined…
