Within the last years the importance of post-market surveillance has been underlined more and more. Thus, MDR/IVDR has a section with 5 articles concerning post-market surveillance (Section I of Chapter VII). Article 83 defines the system which the manufacturer has to establish and which shall be proportionate to risk class and type of device. The aim of this system shall be to actively and systematically gather, record and analyse data on the quality, performance and safety of the respective products. These data shall be incorporated into risk management, clinical evaluation and usability analysis. Furthermore, manufacturers shall  use the data to identify needs for corrective and preventive actions (CAPA) and implement appropriate measures subsequently.

Especially MDR/IVDR considerably tightens the reporting for surveillance purposes: According to Article 85 manufacturers of class I products shall prepare a post-market surveillance report and update this report when necessary. This report shall be made available to the competent authority upon request.

Manufacturers of class IIa, IIb and III devices shall prepare a periodic safety update report (PSUR). For class III and implantable devices the PSUR has to be submitted to the notified body as article 86 specifies. The PSUR shall be updated at least annually (class IIb and III devices) or every two years (class IIa devices) and shall be part of the technical documentation except in the case of custom-made devices.