Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the notified body and the competent authority upon request.
Home› Health & Pharmaceuticals› In Vitro Diagnostic Medical Devices Regulation
Chapter VII · POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE › Section 1 · Post-market surveillance › Article 80
Post-market surveillance report
←→ also move between articles