Article R5221-24 of the French Public Health Code
November 1, 2023
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the in vitro diagnostic medical device with the essential requirements set out in Section 5 of this Chapter. He shall specify the principles for ensuring the quality of his production and guarantee that his manufacturing process complies with these principles. The manufacturer shall establish and maintain…
