Blog

Your blog category

PMCF Under EU MDR: How to Plan It Right

 150 150 RN Consulting Solutions

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.

    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/

    Stay informed, stay compliant!

    A Quick Guide to Medical Device Vigilance Reporting

     150 150 RN Consulting Solutions

    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/

    Stay informed, stay compliant!

    What Is a CAPA System?

     150 150 RN Consulting Solutions

    In the highly regulated world of medical devices, maintaining product quality and patient safety is non-negotiable. One of the most critical quality systems used to achieve this is the Corrective and Preventive Action (CAPA) system.

    A CAPA system is a structured, documented process used to identify, investigate, and resolve quality issues—both actual and potential. For MedTech companies, CAPA is not just a best practice; it’s a regulatory requirement. The FDA’s 21 CFR Part 820.100 and ISO 13485:2016 (Sections 8.5.2 and 8.5.3) both mandate that medical device manufacturers implement an effective CAPA system.

    So, what does a CAPA process actually involve? Let’s walk through the steps and key elements needed for a compliant and functional CAPA program.

    The CAPA Process: 5 Key Steps

    A successful CAPA system follows a logical sequence that must be carried out thoroughly to effectively address root causes and prevent recurrence.

    Common Challenges in CAPA Implementation

    • Inadequate Root Cause Analysis: Many CAPAs fail because the team never finds the true root cause. This often happens due to assumptions, lack of structured methodology, or insufficient training.

    ✅ Solution: Choose and stick to a proven RCA tool (e.g., 5 Whys), train your team, and document findings thoroughly.

    • Overuse or Underuse of CAPA: Some companies initiate a CAPA for every minor issue (leading to process fatigue), while others fail to initiate CAPAs for significant problems.

    ✅ Solution: Develop clear SOPs that define what qualifies as a CAPA-worthy issue. Train teams to use CAPA judiciously, based on the risk and scope of the problem.

    • Lack of Cross-Functional Involvement: When CAPA is seen as the “Quality team’s responsibility,” it quickly loses effectiveness. Many issues span multiple departments and require broader insights.

    ✅ Solution: Involve a cross-functional team in the investigation and resolution process. Encourage a company-wide culture where quality is everyone’s responsibility.

    A CAPA system isn’t just a checkbox for regulatory compliance—it’s a strategic tool for continuous improvement. When implemented correctly, it helps medical device companies not only fix issues but also prevent them from recurring.

    By investing in proper training, defining clear procedures, and fostering cross-functional collaboration, MedTech organizations can build a CAPA system that strengthens product quality, reduces risk, and protects patient safety.

    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!

    Clinical evaluation – your path to the EU market

     1024 682 RN Consulting Solutions

    How can a manufacturer sell their medical devices in the European Union (EU)? This is an easy question. You need to show conformity of your device with the EU’s regulatory requirements, which are primarily governed by the Medical Device Regulation 2017/745 (EU MDR).

    Sounds easy right!! Unfortunately, this is not an easy process. Clinical evaluation forms the core of your conformity assessment. EU MDR defines ‘clinical evaluation’ as a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

    The primary goal of clinical evaluation is to demonstrate performance and safety of the device in accordance with the relevant General Safety and Performance Requirements (GSPRs). To this end various data need to be evaluated. The two main type of data included are:

    • Data held by the manufacturer which includes premarket clinical investigations, verification and validation test reports, post-market data etc.
    • Data retrieved from literature is used to identify data not held by the manufacturer that are needed for the clinical evaluation.

    The data retrieved through literature is used to establish the current knowledge or state-of-the-art as well to collect relevant clinical data. Clinical data is a term that you will frequently come across. So what is clinical data? ‘Clinical data’ means information concerning safety or performance that is generated from the use of the device under evaluation or a device for which equivalence to the device. From the state-of-the-art, we need identify suitable parameters that can be used to evaluate the performance and safety of the device under evaluation, and establish acceptance criteria. These parameters and the acceptance criteria are then used to evaluate the performance of your device.

    Risk-benefit analysis is another critical element of clinical evaluation for medical devices, ensuring that the device’s benefits to patients and users outweigh the associated risks. Under the EU MDR risk-benefit analysis is a core requirement for demonstrating compliance with the GSPR. This analysis underpins the device’s approval process and its ongoing market viability.

    Clinical evaluation under EU MDR

    The MDR emphasizes a lifecycle approach to clinical evaluation, requiring continuous monitoring and updates. Key differences from the previous Medical Device Directive (MDD) include:

    • Greater focus on clinical evidence for all devices, including those already on the market.
    • Stricter requirements for demonstrating equivalence when using data from similar devices.
    • More comprehensive post-market surveillance and PMCF activities.

    Challenges in Conducting Clinical Evaluation

    • Demonstrating Equivalence: Ensuring the device is technically, clinically and biologically comparable to an equivalent device can be complex. Learn more.
    • Data Gaps: Insufficient clinical data may necessitate new clinical investigations, increasing time and cost.
    • Regulatory Scrutiny: Notified Bodies have become more stringent, especially for high-risk devices, making detailed and well-supported evaluations critical.

    How can RNCS help?

    • Plan and execute a thorough literature search
    • We leverage various tools to gather and manage data efficiently
    • We can help you meet the regulatory requirements as per EU MDR.

    Clinical evaluation isn’t just about ticking regulatory boxes—it’s the cornerstone of crafting medical devices that transform patient care while keeping risks at bay. By embracing a forward-thinking and meticulous approach, manufacturers can not only meet compliance standards but also carve out a competitive edge in the fast-paced world of healthcare innovation.

    Whether you’re just stepping into the game or fine-tuning your approach, mastering clinical evaluation principles is your golden ticket to thriving in the medical device industry.

    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!