Subsection 6: EC type-examination.

As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, called a 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 include,…

For the purposes of the EC declaration of conformity procedure referred to in the first paragraph of Article R. 5211-40 and the EC type-examination procedure referred to in the first paragraph of Article R. 5211-41, in the case of a medical device or an active implantable medical device manufactured utilising tissues of animal origin referred to in Article R. 5211-23-1, the authorised body shall assess, in accordance with the procedures…