CE Marking
Marketing and CE marking of in vitro diagnostics tests and systems
In France and Europe, the marketing of in vitro diagnostic tests and systems is covered by Directive 98/79/EC on in vitro diagnostic medical devices, based on 2 pillars:
- Products’ compliance with high standard requirements: in vitro diagnostics manufacturers must provide documentation showing their products’ compliance with these requirements in a technical dossier that is available to the competent authorities within the scope of post-market surveillance.
- Post-market surveillance which relies on three parties actively involved in surveillance: (1) Clinical laboratories and other users (reactovigilance), (2) Manufacturers that take corrective actions when necessary and (3) Competent authorities that, if necessary, will put in place all necessary safety and health measures.
