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PMCF Under EU MDR: How to Plan It Right

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Post-Market Clinical Follow-Up (PMCF) plays a crucial role in post-market surveillance under the EU MDR. It is intended to proactively and continuously collect clinical data on the safety, performance, and benefits of a device throughout its lifecycle.

What is a PMCF plan?

The document that specifies the methods and procedures for proactively gathering and assessing clinical data on a medical device throughout its lifecycle is known as a PMCF plan. The PMCF plan should describe how the company will:

  • Confirm the device’s safety, performance, and clinical benefits (if applicable) over its lifetime
  • Detect previously unknown side effects and monitor known side effects and contraindications
  • Identify and evaluate emergent risks
  • Ensure the continued benefit-risk ratio acceptability
  • Detect potential systematic misuse or off-label use of the device 

What does the PMCF plan contain?

MDCG 2020-7 provides guidance on what needs to be included in the PMCF plan. The main sections in the PMCF plan are: 

  1. The manufacturer contact details
  2. A description and specification of the medical device under study
  3. The activities that shall be used to collect clinical data
  4. Reference to any relevant parts of the technical documentation
  5. Evaluation of clinical data on equivalent or similar devices
  6. References to any applicable common specifications, harmonized standards, or guidance documents
  7. Estimated date of the PMCF evaluation report

The outcome of the activities being planned in this document shall be included in the PMCF report. 

Choosing the right PMCF activities for your device

Choosing the PMCF activities is the most important part of a PMCF plan. PMCF activities are divided into

  • General activities
    • For low-risk devices.
    • Long-term safety and performance are known.
    • Produces subjective data that cannot be used alone to scientifically document safety and performance.
    • General PMCF activities include:
      • Feedback from users (e.g. from patients, healthcare professionals)
      • Screening of scientific literature
      • Summary of clinical experience gained (e.g. from physicians)
      • Other sources of clinical data, such as published data and research on similar devices
  • Specific activities
    • For high-risk devices.
    • Used to answer uncertainties or new concerns.
    • Produces objective data that is scientifically sound and can be used to demonstrate safety & performance.
    • Specific PMCF activities include:
      • Evaluation of data from suitable registries
      • High quality specific surveys
      • PMCF studies (prospective or retrospective)
      • Case cohorts

Guidelines for Developing an Effective PMCF Plan

Given the wide range of medical devices and their varying benefit-risk profiles, there is no universal approach to creating a PMCF plan. However, the following tips can help guide your strategy as you start to develop a plan tailored to your device.

1. Identify Data Gaps in Pre-Market Evidence

    Start by reviewing your pre-market clinical evaluation. Pinpoint areas where the evidence is weak, outdated, or limited—such as in long-term safety, off-label use, or specific patient populations.

    2. Define Clear PMCF Objectives

      Your plan should clearly outline what you’re trying to achieve. Objectives may include:

      • Verifying clinical performance and safety
      • Monitoring known risks or emerging risks
      • Confirming continued benefit-risk acceptability
      • Detecting rare or long-term side effects
      • Identifying off-label or systematic misuse

      3. Choose Appropriate PMCF Activities

      Select suitable methods based on your device type, classification, and usage.

      Announcement Note: Clinical investigation is not the only way to collect clinical data

      Depending on your device’s risk classification, expected lifespan, and the availability of existing clinical data, other PMCF activities such as high-quality surveys, data collected from the device itself, scientific literature etc., may also be appropriate.

      In some cases, a clinical investigation will be necessary. However, the decision should be based on a thorough assessment of the device and any identified gaps in the clinical evidence.

      4. Engage Cross-Functional Expertise

      Involve clinical, regulatory, quality, and post-market teams in creating the plan. Their insights help ensure the plan is practical, compliant, and aligned with business goals.

      5. Include Detailed Methodology

      Describe how each PMCF activity will be carried out, including:

      • Study design or survey structure
      • Sample size and target population
      • Data collection tools
      • Analysis plan
      • Milestones and timelines

      6. Ensure Link to PMS and Risk Management

      Your PMCF plan must integrate with your overall Post-Market Surveillance (PMS) system and be consistent with your risk management documentation. Updates in one area should feed into and inform the other.

      7. Plan for Continuous Updates

      PMCF is not a one-time activity. Define review periods to assess findings and revise the plan based on new risks, changes in technology, or clinical developments.

      For more details, Contact RN Consulting Solutions MedTech Compliance Experts

      👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/

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      A Quick Guide to Medical Device Vigilance Reporting

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      Medical device vigilance systems are designed for the notification and evaluation of adverse events. Their primary goal is to enhance the protection and safety of patients and other users by reducing the likelihood of recurrence of adverse events related to the use of any medical device.

      What is vigilance reporting?

      Article 87 of the EU MDR states that manufacturers must report any serious incidents or field safety corrective actions involving devices made available on the Union market to the relevant competent authorities.

      Note: A serious incident means any adverse event that led to death, temporary/ permanent deterioration of health or a public health threat.

      What are the factors leading to a vigilance report?

      1. Death: Device or use error leading to the death of the patient/ user
      2. Serious Injury: Irreversible harm that requires medical or surgical intervention
      3. Public Health Threat: An incident that presents a large-scale or unforeseen threat to public health
      4. Field Safety Corrective Action:  Actions taken by manufacturer to reduce risk to patients/ users

      When and where to report?

      JurisdictionGuidanceInitial reporting timelineWhere to report
      Europe*EU MDR Article 872 days: Serious public health threat 10 days: Death or unanticipated serious deterioration 15 days: All other serious incidentsNational portals (ANSM, Swissmedic, BfArM etc)**
      USA***FDA 21 CFR Part 80330 days: Death, serious injury, or malfunction 5 days: if action to prevent significant public health riskeMDR
      * MDCG 2023-3 rev.2
      ** Until EUDAMED is in place
      *** 21 CFR 803.10

      How to implement an effective vigilance reporting process?

      Efficient vigilance reporting by medical device manufacturers requires a structured, proactive approach that ensures timely detection, evaluation, and submission of adverse events.

      ✅ Establish a Robust Internal Reporting System

      • Implement a clear and accessible process for employees, healthcare providers, and customers to report incidents.
      • Train staff regularly on identifying and escalating reportable events.

      ✅ Define Roles and Responsibilities

      • Designate a vigilance officer or team responsible for monitoring, assessing, and reporting incidents.
      • Utilize cross-functional team consisting of quality, regulatory, clinical, and customer support teams.

      ✅ Follow Regulatory Timelines Strictly

      • Be familiar with jurisdiction-specific timelines (e.g., 2–10–15 days in the EU, 10–30 days in the US).

      ✅ Conduct Effective Root Cause Analysis (RCA)

      • For every reportable incident, perform a structured RCA to determine if the incident is systemic.
      • Use tools like 5 Whys or Fishbone diagrams to guide investigations.

      ✅ Integrate with CAPA and Risk Management

      • Ensure findings from vigilance feed into your CAPA system.
      • Update risk management files and, if necessary, take preventive or corrective actions.

      ✅ Review and Update Procedures

      • Regularly review vigilance SOPs to reflect current regulations (EU MDR, FDA 21 CFR Part 803, etc.).
      • Include lessons learned from past incidents and audits.

      ✅ Monitor Trends

      • Implement trend analysis for non-serious events (as required under EU MDR Article 88).
      • Use this analysis to proactively identify risks before they escalate.

      In conclusion, an effective medical device vigilance reporting system is not just a regulatory obligation—it’s a vital component of patient safety and product quality. By streamlining processes, leveraging data, and fostering cross-functional collaboration, manufacturers can respond swiftly to risks, enhance compliance, and build trust with regulators and users alike.

      For more details, Contact RN Consulting Solutions MedTech Compliance Experts

      👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/

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      Building an Effective PMS System

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      EU MDR defines PMS as “all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions”.

      The PMS documents include:

      DocumentExplanationEU MDR Reference
      PMS PlanA well-defined plan specifying the process of collection and utilization of data related to serious / non-serious incidents, undesirable side-effects, trend reporting, feedback, complaints etc.Article 84 Section 1.1, Annex III
      PMS ReportReport summarising the results and conclusions of the analyses of the PMS data for Class I devices.Article 85
      Periodic Safety Update Report (PSUR)A summary of safety and performance of a Class IIa, IIb or III device evidenced through the data collected through PMS activities.Article 86

      Reporting timeline

      DocumentClass IClass IIaClass IIbClass III and implantable devices
      PMS Plan✔ Yes✔ Yes✔ Yes✔ Yes
      PMS Report✔ To be updated when necessary☓☓☓
      PSUR☓✔ Every 2 years✔ Annually✔ Annually
      Submission to Competent Authority✔ Upon request✔ Upon request✔ Yes✔ Yes
      Submission to Notified Body☓✔ Yes✔ Yes✔ Yes
      EUDAMED☓☓☓✔ Yes
      End of PSUR requirement Mandatory until end of the device lifetime defined in technical documents.

      In conclusion, Post-Market Surveillance is a fundamental component of EU MDR, ensuring that medical devices continue to meet safety and performance requirements throughout their lifecycle. With clearly defined documentation such as the PMS Plan, PMS Report, and PSUR, manufacturers are expected to proactively monitor and respond to real-world data. Compliance with PMS obligations not only fulfills regulatory requirements but also strengthens patient safety, supports continuous improvement, and builds trust in medical device performance over time.

      How can RNCS help?

      1. Development of a PMS strategy tailored to device risk class and type
      2. Preparation of PMS documents which meet MDR requirements and MDCG guidelines
      3. Analysis of collected data and preparation of reports
      4. Updating PMS documents based on post-market data or design changes
      5. Integration of findings into risk management and clinical evaluation documents
      6. Preparation of responses to Competent Authorities and Notified Bodies

      For more details, Contact RN Consulting Solutions MedTech Compliance Experts

      👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/

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      Trend Reporting: Compliance with Article 88 of EU MDR

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      As per Article 88 of EU MDR manufacturers must analyze and report any statistically significant increase in

      • non-serious incidents
      • expected undesirable side effects

      that could negatively impact the benefit-risk balance and pose unacceptable risks to health or safety. This increase should be assessed against the expected frequency or severity for the device over a defined period.

      Why is this important?

      • Proactive Safety Monitoring: MDR shifts from reactive to proactive safety evaluation.
      • Data Analytics: Manufacturers need robust tools and statistical methods for early detection of trends.
      • Audit Focus: Notified Bodies are increasingly scrutinizing trend analysis during audits.
      • Integration with PMS & PMCF: Trend analysis must be integrated with PMS plans and feed into Periodic Safety Update Report (PSUR) or PMS reports.
      • Cross-functional Challenge: It involves coordination between clinical, regulatory, quality, and data analysis teams.

      What needs to be done?

      1. Set up well-defined procedures for managing incidents within your organization, and specify the observation period to support thorough and effective monitoring
      2. Develop a clear method for evaluating statistical significance using available data
      3. Define clear thresholds and statistical methods, and where possible automate signal detection
      4. Monitor, record and analyze any complaints or incidents related to the medical device. If there is a statistically significant increase, this should be reported
      5. Integrate the findings in the PSUR or PMS report

      What happens once a report is submitted?

      1. Competent authorities may conduct their own assessments of trend reports, which may require the manufacturer to implement appropriate measures to ensure the protection of public health and patient safety.
      2. Each competent authority shall inform the Commission, other competent authorities, and the notified body that issued the certificate of the results of such assessments and any measures adopted.

      In conclusion, trend reporting under the EU MDR is a critical post-market surveillance (PMS) requirement, driven by stricter obligations and a proactive approach to identifying potential risks. By detecting emerging issues early and responding with appropriate measures, manufacturers not only ensure regulatory compliance but also reinforce their commitment to continuous improvement and public health protection. A well-defined trend reporting process, integrated into the broader PMS system, is essential for maintaining the benefit-risk balance throughout the device lifecycle.

      For more details, Contact RN Consulting Solutions MedTech Compliance Experts

      👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/

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      Equivalence Under EU MDR: A Regulatory Pathway to Clinical Evidence

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      EU MDR insists on clinical data to prove the safety and performance of the device under assessment. Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety and performance of devices for the purpose of CE marking. But EU MDR provides a possibility to use clinical data sourced from data of a device for which the equivalence to the device in question can be demonstrated. This data can be sourced from either:

      • clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated
      • reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated

      To be able to use this data, the equivalence needs to be established beyond doubt by considering the clinical, technical and biological characteristics. Let’s look at what these mean in detail.

      1. Clinical characteristics: The device is intended for the same clinical condition or purpose, addressing a similar severity and stage of disease, and is used at the same anatomical site in a comparable patient population, considering factors such as age, anatomy, and physiology. It is operated by the same type of user and demonstrates similar critical performance relevant to the expected clinical outcomes for its intended use.
      2. Technical characteristics: The device shares a similar design and is intended for use under comparable conditions. It exhibits similar specifications and characteristics, including physicochemical properties such as energy intensity, tensile strength, viscosity, surface features, wavelength, and software algorithms. Where applicable, it employs similar deployment methods and operates on comparable principles, meeting equivalent critical performance requirements.
      3. Biological characteristics: The device is made of the same materials or substances that come into contact with the same human tissues or body fluids, for a similar type and duration of contact. It also has similar release properties, including those related to degradation products and leachables.

      These characteristics must be sufficiently similar to ensure there is no clinically meaningful difference in the device’s safety or clinical performance. Any claim of equivalence must be supported by sound scientific justification.

      Note: If equivalence is being claimed for an implantable or Class III device with a device from another manufacturer, it is essential to have a current and legally binding agreement in place. This agreement must ensure ongoing access to the necessary technical documentation, in compliance with Article 61(5) of the MDR.

      How can RNCS help?

      • Evaluate whether equivalence is a viable route for your device.
      • Identifying possible equivalent devices
      • Determine if sufficient clinical, technical, and biological similarities exist and demonstrating equivalence
      • Once equivalence is demonstrated- searching and extracting data from peer-reviewed literature, clinical study databases, or manufacturer documentation to include in clinical evaluation
      • Advise whether a clinical investigation is more appropriate based on gaps

      Demonstrating equivalence under the EU MDR is a complex and highly scrutinized process that requires clear, evidence-based justification across clinical, technical, and biological parameters. Unlike the previous MDD, the MDR sets a higher bar for proving equivalence, particularly when relying on data from third-party devices. Manufacturers must ensure that any claims of similarity are supported by detailed comparisons and, where necessary, formal access to the technical documentation of the equivalent device. When approached systematically and supported by robust scientific evidence, the equivalence pathway can be a valuable tool to meet regulatory requirements while optimizing development timelines and minimizing the need for new clinical investigations.

      For more details, Contact RN Consulting Solutions MedTech Compliance Experts

      👉 Follow us on LinkedIn for expert insights on medical device compliance, EU MDR, FDA regulations, and quality system strategies. https://www.linkedin.com/company/rn-consulting-solutions/

      Stay informed, stay compliant!