The post-market surveillance system referred to in Article 78 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III. The post-market surveillance plan shall be part of the technical documentation specified in Annex II.
Home› Health & Pharmaceuticals› In Vitro Diagnostic Medical Devices Regulation
Chapter VII · POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE › Section 1 · Post-market surveillance › Article 79
Post-market surveillance plan
←→ also move between articles