Manufacturers of class I 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 84 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 competent authority upon request.
Home› Health & Pharmaceuticals› Medical Devices Regulation
Chapter VII · POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE › Section 1 · Post-market surveillance › Article 85
Post-market surveillance report
←→ also move between articles