Post Market Surveillance Report

In (Definition 60) Article 2 of the EU Medical Devices Regulation (MDR 2017/745), the scope and goal of post market surveillance in the European Union are clearly stated:

In 2017/745, the European Commission lays out highly detailed rules for how the post-market surveillance system, as part of the quality management system, should be utilised to collect feedback from device users. This system should be thorough, proactive, and systematic, enabling collaboration on market surveillance and vigilance. It should also interact with corrective or preventative action procedures and be appropriate to the risk and kind of device. The PMS system will create key inputs for technical documentation, product benefit-risk, clinical evaluation procedure, and Clinical Evaluation Report (CER).