Periodic Safety Update Reports (PMS Reports) and Periodic Safety Update Reports (PSURs) play a central role in the management of Post-Market Surveillance (PMS) for Medical Devices, as required by the MDR Regulation (EU) 2017/745. These documents are essential to ensure that devices continue to meet safety and performance standards after they have been placed on the market and are crucial parts of the technical documentation.

Depending on the risk class of the device, the Regulation distinguishes between two types of reports:

• PMS Report (Art. 85): mandatory for Class I devices.
• PSUR (Art. 86): required for Class IIa, IIb and III devices.

Both documents share the objective of regular updates on safety and the benefit-risk ratio but differ in the details to be presented.

PMS Report for Class I Devices

Article 85 of the MDR indicates that manufacturers of Class I devices must prepare a Post-Market Surveillance Report (PMS Report) summarising the results and conclusions of the analyses required by the Post-Market Surveillance Plan (Art. 84 of the MDR). The PMS Report must include a rationale (justification) and description of any preventive or corrective actions taken. It must be updated when necessary and made available to the competent authority upon request.

The PMS Report includes:

• Collection and analysis of information on post-market events and device performance;
• Description of preventive and corrective actions taken;
• Regular updates, based on the data collected.

The PMS Report must be updated when necessary and made available to the competent authorities upon request. This document represents tangible evidence of the effectiveness of the implemented post-market surveillance activities.

PSUR: the Advanced Tool for Medium-High Class Devices

 Article 86 of the MDR refers to Class IIa, Class IIb and Class III manufacturers who must prepare a Periodic Safety Update Report (PSUR) summarising the results and conclusions of the analysis of post-market surveillance data collected under the post-market surveillance plan referred to in Article 84.

The PSUR is more detailed than the PMS Report and includes the following information:

• Benefit-risk assessment based on post-market data;
• Results of post-market clinical follow-up (PMCF);
• Information on serious and non-serious accidents;
• Information on safety corrective actions taken to mitigate emerging risks, in particular Field Safety Corrective Action (FSCA);
• Market feedback, including information provided by users, importers and distributors, comments and complaints;
• Data on similar devices or collected in scientific contexts.
• Results of trend analyses.

The manufacturer must update the PSUR document:

• At least annually for Class IIb and III devices.
• Every two years for Class IIa devices, unless there is a special need.

PSURs of class III devices or implantable devices must be made available to the Notified Body via the EUDAMED database to be appropriately assessed.  Until EUDAMED is fully operational, PSURs will be shared through alternative modes.

PSURs of Class IIa and IIb non-implantable devices must be made available to the Notified Body during surveillance activities or upon request.

Guidelines

In addition to MDR (EU) 2017/745, medical device manufacturers may refer to:

• MDCG 2022 – 21 guideline specifying the information to be presented within a PSUR.
• MDCG 2023-3 clarifying key concepts related to market surveillance;

Strategic Value of PMS Report and PSUR

Both of these documents are not simply regulatory obligations but represent strategic tools for the organisation. They are needed to improve the safety and effectiveness of devices, providing a clear picture of problems and corrective actions. They demonstrate compliance during audits and inspections. In addition, they support decisions based on real data to improve product characteristics and labelling.

The PMS Report and PSUR are indispensable elements of effective post-market surveillance management.

Complife can support you in the management of post-market documentation and the drafting of PMS Reports and PSURs through its strategic-regulatory consulting services.