Medical Device Post-Market Surveillance in the EU: PMCF, PMSR, and PSUR

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Clinical Literature Reviews

In the field of medical device regulation, post-market surveillance (PMS) plays a crucial role in ensuring the ongoing safety and performance of marketed devices. The requirements for PMS of medical devices sold in the European Union (EU) are outlined in the Medical Device Regulation (MDR 2017/745). Within this framework, three key components exist to ensure manufacturers are properly capturing, documenting, and reporting the Post-Market phase of the medical device lifecycle: the Post-Market Clinical Follow-up (PMCF), Post-Market Surveillance Report (PMSR), and Periodic Safety Update Report (PSUR). These elements are all based on the post-market surveillance plan, and each serves a specific purpose in monitoring medical devices after they have been approved for market release. This article will delve into the contents and details of each and provide insights into the types of devices for which each should be used.

Post-Market Clinical Follow-up (PMCF)

Post-Market Clinical Follow-up (PMCF) refers to the proactive collection and evaluation of clinical data that demonstrates the ongoing safety and performance of a medical device in its actual use environment. MDR Annex XIV Part B states that PMCF should confirm the safety and performance of the device throughout the expected lifetime. This process entails gathering data from real-world clinical experience, patient feedback, and scientific literature. The PMCF aims to assess the device’s benefits, risks, and potential limitations through post-market clinical investigations or ongoing data collection, complementing pre-market clinical trials. MDG2022-21 states that the PMCF should include at least:

  • the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
  • the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
  • a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
  • a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I;
  • the specific objectives to be addressed by the PMCF;
  • an evaluation of the clinical data relating to equivalent or similar devices;
  • reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and
  • a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer.

Post-Market Surveillance Report (PMSR)

The Post-Market Surveillance Report (PMSR) is for lower risk class I devices. Manufacturers of these devices must compile a post-market surveillance report outlining the findings and conclusions from the analysis of post-market surveillance data collected under the Post-Market surveillance plan. This report should also include explanations and details of any preventive or corrective actions implemented. The report must be kept up-to-date and provided to the competent authority upon request.

Periodic Safety Update Report (PSUR)

The Periodic Safety Update Report (PSUR) is required for higher-risk medical devices, which include class IIa, class IIb, class III and implantable devices. It also applies to class C or class D IVDs regulated under IVDR. It is a systematic document first submitted during the conformity assessment audit to the Notified Body. Thereafter, manufacturers of class IIa devices must update the PSUR when necessary and at least every two years. Manufacturers of class IIb and class III devices must update it at least annually.

The primary goal of a PSUR is to provide an overview of the findings and insights obtained from the analysis of post-market surveillance data concerning a specific medical device or a group of devices. This enables the identification and reporting of any potential changes to the benefit-risk profile of the medical device(s), taking into account newly available or emerging information within the broader context of cumulative data on the device’s benefits and risks.

The report includes data from various sources, such as clinical trials, adverse event reports, and scientific literature. MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) According to Regulation (EU) 2017/745 (MDR) states that “the aim of the PSUR is not to duplicate all data and reports generated by the PMS Plan but to summarize all results and conclusions.” It aids in the detection and analysis of trends and facilitates evidence-based decision-making related to device safety improvements. According to MDG2022-21, the PSUR should provide:

  • the conclusions of the benefit-risk determination
  • the main findings of the Post-Market Clinical Follow-up (PMCF)
  • the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, when practicable, the usage frequency of the device.

In order to prepare the above summary, the following elements should be considered:

  • Information concerning serious incidents and field safety corrective actions;
  • records referring to non-serious incidents and data on any undesirable side effects;
  • information from trend reporting;
  • relevant specialist or technical literature, databases and/or registers;
  • information, including feedbacks and complaints, provided by users, distributors and importers;
  • publicly available information about similar medical devices

While PSURs, PMCFs, and PMSRs have overlapping purposes in ensuring post-market device safety, they differ in their specific scope and focus, and they collectively contribute to ensuring the safety, effectiveness, and ongoing monitoring of medical devices in real-world clinical settings. Understanding their unique characteristics and appropriate utilization is vital for manufacturers, regulatory authorities, and healthcare professionals to maintain the highest possible standards of device safety and patient care.

How Nerac Can Help?

Nerac’s Medical Device team has experience developing MDR 2017/745 compliant documents. Our analysts are experts in identifying and analyzing Post-Market clinical and vigilance data. Contact Nerac today to discuss how we can help you with your Post-Market surveillance needs.

About the Analyst

Miriam Sharif-Murray, M.S., RAC

Miriam Sharif-Murray brings over 20 years of medical device/regulatory experience to Nerac clients. After completing her degrees, she worked as a chemist for chemical and medical device manufacturers where she further strengthened her scientific knowledge and built her expertise in the regulatory environment.

Academic Credentials

  • M.S., Biology, Tennessee State University
  • B.A., Biology, Fisk University

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