Preparing for Europe’s Evolving Medical Device Regulation

The Essential Guide to EU MDR Compliance

Post-Market Surveillance (PMS)

Post-Market Surveillance (PMS)

The new MDR places greater emphasis on post-market surveillance (PMS) with the aim of continuously monitoring the quality, performance, and safety of a device throughout its entire lifecycle. PMS enables manufacturers to quickly identify issues with the design, manufacture, or use of the device and ultimately enhance patient safety.

Under the new regulations, manufacturers need to develop a PMS plan and report as part of their technical documentation.

The PMS plan should include:

  • Proactive and systematic process for collecting data related to serious incidents, product trends, customer complaints, user feedback, etc.
  • Effective and appropriate methods to assess collected data
  • Indicators and threshold values for assessing risk-benefit and effective risk management
  • Methods and tools for investigating complaints and other market-related information gathered in the field
  • Methods and protocols to manage events subject to the trend report, as outlined in Article 88
  • Protocols for communicating with competent authorities, notified bodies, economic operators, and users
  • Reference to procedures that fulfill manufacturer obligations for the PMS system, PMS plan, and periodic safety update report (PSUR)
  • Processes and procedures for implementing corrective actions
  • Tools to effectively trace potentially defective products

The PMS reporting requirements will depend on the classification of the device.

Post-Market Surveillance Report (PMSR)

Post-market surveillance reports (PMSRs) are required for Class I medical devices. The PMSR should provide a summary of results and conclusions about post-market surveillance data defined in the PMS plan, as well as the rationale and description of any corrective or preventive actions taken. The report should be updated on an as needed basis.


Action Item - Prepare a post-market surveillance plan

Periodic Safety Update Report (PSUR)

Periodic safety update reports (PSURs) are required for Class IIa, IIb, and III devices. In addition to the information contained in the post-market surveillance report, the PSUR should also include key findings from the postmarket clinical follow-up (PMCF), conclusion of the benefit/risk determination, and data on sales volumes, user populations, and frequency of use. The report must be updated every two years (at minimum) for Class IIa devices and at least once a year for Class IIb and Class III devices.

Arena QMS Tip:

Quality Templates

Leverage the Arena quality templates to help formulate your post-market surveillance plan and reports. Once created, they are linked to your product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.

EU MDR Documentation Maintenance Requirements9


Class I

Class IIa

Class IIb

Class III/Implantable Devices

Clinical Evaluation Report (CER)
[Article 6 1 (11), MEDDEV 2.7.1/4 (6.2.3)]
When Necessary When Necessary or At Least Every 2-5 Years At Least Annually
Post-Market Clinical Follow-up (PMCF) Evaluation Report
[Article 61 (11), Annex XIV Part B (7)]
When Necessary When Necessary or At Least Every 2 years At Least Annually 
Summary of Safety and Clinical Performance (SSCP)
[Article 32, 61 (11)]
N/A N/A  N/A Annually (If Indicated)
Risk Management Report
[Annex I (3)]
Regular Systematic Update 
Periodic Safety Update Report (PSUR)
[Article 86 (1)]
N/A At Least Every 2 Years At Least Annually At Least Annually
Post-Market Surveillance Report (PMSR) [Article 85] When Necessary N/A N/A N/A
Technical File Continually

Note: Although all reports have different submission schedules depending on the device classifications, it is the PSUR that will trigger the updates of the other documents.