Article R5221-28 of the French Public Health Code
November 1, 2023
As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer must submit to an authorized body for verification the manufacturing quality system which he has set up to ensure conformity of the in vitro diagnostic medical devices with the approved type described in an EC type-examination certificate. The manufacturer submits an application to the approved body for assessment of this quality system, which includes technical documentation…
