Article R5221-26 of the French Public Health Code
November 1, 2023
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, known as the type, of the production envisaged in order that the body may check that this sample satisfies the essential requirements defined in Section 5 of this Chapter which apply to the devices under consideration. The manufacturer must submit an application for assessment to an authorized body, which must…
