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Clinical Evaluation Under EU MDR: Building Evidence That Stands Up to Scrutiny

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In the evolving landscape of the European Union Medical Device Regulation (EU MDR 2017/745), clinical evaluation has become more than a regulatory requirement — it’s a demonstration of trust, transparency, and accountability.

Manufacturers are now expected to go beyond simple claims of safety and performance and build robust clinical evidence that withstands the highest level of scrutiny from Notified Bodies and Competent Authorities.

What is Clinical Evaluation?

Clinical evaluation is the systematic and planned process of continuously generating, collecting, and analyzing clinical data to demonstrate that a medical device meets the General Safety and Performance Requirements (GSPR).

It forms a cornerstone of the technical documentation and is directly tied to the device’s risk classification and intended purpose. In essence, clinical evaluation answers three key questions:

  1. Is the device safe?
  2. Does it perform as intended?
  3. Are the benefits greater than the risks?

Key Components of Clinical Evaluation

A robust clinical evaluation process under EU MDR should include the following components:

  1. Clinical Evaluation Plan (CEP): A roadmap defining the scope, objectives, and methodology for evaluating clinical evidence. The CEP outlines how data will be collected, assessed, and updated throughout the device lifecycle.
  2. Identification of Clinical Data: This involves gathering data from a wide range of sources — including clinical investigations, scientific literature, equivalent devices, and post-market data.
  3. Appraisal and Analysis of Data: Not all data carry equal weight. The evaluation must assess the relevance, quality, and robustness of each data source, ensuring the conclusions are evidence-based.
  4. Clinical Evaluation Report (CER): The CER consolidates all findings, summarizing how the evidence supports safety and performance claims. It should clearly align with the device’s intended use, risk profile, and clinical benefits.
  5. Post-Market Clinical Follow-Up (PMCF): Clinical evaluation doesn’t end with CE marking. PMCF ensures continuous validation of the device’s performance and safety once it’s in real-world use, feeding back into the clinical evaluation lifecycle.

Common Challenges Under EU MDR

While clinical evaluation was also part of the former MDD, the MDR sets a much higher bar for evidence quality. Common challenges include:

  • Limited clinical data for legacy devices.
  • Difficulty demonstrating equivalence due to stricter criteria.
  • Increased expectations for ongoing clinical evidence through PMCF.
  • Enhanced scrutiny by Notified Bodies demanding traceability and justification.

Manufacturers can overcome these challenges by adopting a strategic, data-driven approach — integrating regulatory, clinical, and post-market teams early in the process.

Best Practices for a Defensible Clinical Evaluation

✅ Start Early: Incorporate clinical evaluation planning during device design and development.
✅ Be Transparent: Clearly justify data sources, methodologies, and limitations.
✅ Stay Current: Regularly update the CER with PMS and PMCF data.
✅ Engage Experts: Involve qualified clinical evaluators familiar with the device technology and clinical domain.
✅ Document Everything: Maintain a clear audit trail linking all evidence to GSPR compliance.

Conclusion

Clinical evaluation under EU MDR is not just a regulatory checkbox — it’s a reflection of a manufacturer’s commitment to patient safety and product excellence.

By building a comprehensive, evidence-based, and continuously updated clinical evaluation, manufacturers can ensure their devices not only meet compliance requirements but also earn lasting credibility in the market.

In today’s MDR environment, the strongest competitive advantage lies in robust clinical evidence. Compliance is no longer just about meeting expectations — it’s about exceeding them with confidence and clarity.

For more details, Contact RN Consulting Solutions MedTech Compliance Experts

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Vigilance Reporting under EU MDR: What Every Manufacturer Needs to Know

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Vigilance reporting under the EU MDR is a cornerstone of patient safety, aimed at ensuring timely detection, analysis, and correction of serious hazards related to medical devices on the EU market.

What Is Vigilance Reporting?

Vigilance reporting is the systematic process of identifying, documenting, and reporting serious incidents and field safety corrective actions (FSCAs) involving medical devices that are already on the market. The aim is to detect and prevent recurrence of adverse events, ensuring continuous protection of patients, users, and third parties.

In essence, vigilance acts as an early warning system—helping authorities and manufacturers take corrective or preventive actions promptly.

Legal Basis under EU MDR

Manufacturers are required to:

  • Report serious incidents and FSCAs to the Competent Authority via EUDAMED.
  • Investigate incidents, assess root causes, and document corrective actions.
  • Maintain post-market vigilance procedures as part of their Post-Market Surveillance (PMS) system.

What Triggers a Vigilance Report?

A vigilance report must be submitted when any of the following occurs:

  • Serious injury: Permanent impairment or medical/surgical intervention needed to prevent it.
  • Death: Fatal outcome potentially related to device malfunction or use error.
  • Field Safety Corrective Action (FSCA): A corrective action implemented to prevent or reduce a risk to health (e.g., device recall, labeling update).
  • Serious public health threat: An incident that may pose widespread or unpredictable risks to the population.

Importance of a Vigilance System

An effective vigilance system helps:

  • Identify safety trends and emerging risks.
  • Improve device design and labeling through feedback.
  • Ensure transparency and regulatory trust.
  • Protect patient safety and uphold manufacturer reputation.

Vigilance reporting isn’t merely a compliance exercise — it’s a critical component of a proactive safety culture.

Best Practices for Manufacturers

To maintain compliance and efficiency, manufacturers should:

  1. Establish clear internal vigilance procedures aligned with Article 87–92.
  2. Train employees to recognize and escalate potential reportable incidents.
  3. Integrate vigilance with risk management and post-market surveillance activities.
  4. Document every vigilance-related activity in a traceable, auditable format.

Vigilance reporting under the EU MDR ensures that safety doesn’t stop at market approval — it continues through constant monitoring, reporting, and improvement. For manufacturers, maintaining a robust vigilance system is both a regulatory obligation and an ethical responsibility to protect patients and sustain trust in medical technologies.

For more details, Contact RN Consulting Solutions MedTech Compliance Experts

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Demystifying PSUR Under EU MDR

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Medical devices placed on the European market must not only demonstrate compliance at the time of CE marking but also maintain safety and performance throughout their lifecycle. To achieve this, the European Union Medical Device Regulation (EU MDR 2017/745) introduced more rigorous post-market surveillance (PMS) requirements, among which the Periodic Safety Update Report (PSUR) is a cornerstone for higher-risk devices.

What is PSUR?

The PSUR is a structured, recurring regulatory document that summarizes and evaluates data collected through PMS activities for a medical device. It provides evidence that the device continues to meet the General Safety and Performance Requirements (GSPRs) over time, ensures continuous benefit-risk evaluation, and supports transparency with regulators. More than just a compliance requirement, the PSUR is a strategic tool that consolidates real-world data, drives corrective and preventive actions, and informs stakeholders about the device’s ongoing safety and performance throughout its lifecycle.

Which devices require a PSUR?

PSUR requirements are outlined in Article 86 of the EU MDR, supported by MDCG 2022-21 guidance. It mandates that manufacturers of Class IIa, IIb, and III devices prepare PSURs at defined intervals.

  • Class IIa devices – PSUR must be updated at least every two years.
  • Class IIb and Class III devices – PSUR must be updated annually.

Purpose of PSUR

The PSUR ensures that manufacturers:

  • Provide regular updates on device safety and performance.
  • Continuously assess the benefit-risk profile.
  • Identify emerging risks or trends from post-market data.
  • Share findings with the Notified Body and competent authorities as required.

What Goes Into a PSUR?

A well-crafted PSUR includes:

  • Device identification: UDI-DI, trade name, and basic device details.
  • Summary of PMS Data: Complaints, incidents, trending, vigilance reports, and feedback.
  • Benefit-risk evaluation: Updated evaluation based on post-market data
  • Volume of sales and usage data: Data on how many devices are on the market and in use.
  • PMCF outcomes (if applicable)
  • Regulatory actions taken: CAPAs, updates to IFU, labeling, or design
  • Conclusions: Demonstrating continued compliance with GSPRs.

Why does PSUR matter?

The PSUR is not just a compliance exercise—it is a proactive tool that:

  • Strengthens patient and user safety.
  • Increases regulatory trust and smooth audits.
  • Helps manufacturers identify market trends and opportunities for improvement.
  • Support proactive risk management
  • Ensures devices remain competitive and compliant in the EU market.

Strategic Preparation Tips

To streamline PSUR development:

  • Integrate PMS and PMCF systems: Use automation to collect and analyze data continuously
  • Visualize trends: Infographics and dashboards help communicate findings to internal and external stakeholders
  • Align with CER and CAPA: Ensure consistency across regulatory documentation
  • Use modular templates: Facilitate updates and reduce turnaround time

Challenges in preparing a PSUR

  • Collecting high-quality real-world evidence.
  • Integrating data from multiple sources (complaints, vigilance, PMCF, registries).
  • Ensuring alignment with the Clinical Evaluation Report (CER) and Risk Management File.
  • Meeting strict update timelines (annual/biannual).

In summary, the PSUR is the backbone of continuous safety monitoring under EU MDR. By systematically evaluating post-market data, it ensures that medical devices consistently meet safety, performance, and regulatory expectations throughout their lifecycle.

For more details, Contact RN Consulting Solutions MedTech Compliance Experts

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Understanding PMCF: A Key Requirement Under EU MDR

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Post-Market Clinical Follow-up (PMCF) is a vital component of the EU MDR 2017/745. It ensures that once a medical device is CE-marked and available on the market, its long-term safety and performance continue to be monitored. The PMCF process culminates in the PMCF Report, which documents the findings and outcomes of ongoing clinical data collection.

What is PMCF?

PMCF is a continuous and proactive process of collecting and evaluating clinical data from the real-world use of a CE-marked device. The goal is to:

  • Confirm the device’s long-term safety and performance,
  • Identify emerging risks or new concerns,
  • Ensure the clinical evaluation remains up to date.

When is PMCF needed?

PMCF activities are particularly important in the following situations:

  • When there are unanswered questions about long-term safety, performance, or effectiveness.
  • For novel technologies or new intended uses.
  • For higher-risk devices and complex use scenarios.
  • When approval was based on equivalent device data, requiring confirmation in real-world settings.

In some cases, PMCF may not be necessary—for example, when sufficient long-term safety and performance data already exists or when other post-market surveillance (PMS) activities adequately address uncertainties.

PMCF Activities

  • General PMCF Activities (for low-risk devices)

➡️ These activities mainly produce subjective data, which cannot be used alone to scientifically confirm safety and performance.

  • Specific PMCF Activities (for high-risk devices)

➡️ These produce objective, scientifically sound data that can demonstrate safety and performance and address regulatory uncertainties.

PMCF Report: Purpose and Content

The PMCF Report consolidates and analyzes the data collected through PMCF activities. Its purpose is to:

  • Provide evidence of continued compliance with the General Safety and Performance Requirements (GSPR).
  • Document how residual risks and uncertainties are being addressed.
  • Support updates to the Clinical Evaluation Report (CER) and the overall technical documentation.

A PMCF Report typically includes:

  1. A description of PMCF activities performed.
  2. Data collected (feedback, literature, surveys, clinical studies).
  3. Analysis of results and identification of new risks.
  4. Conclusions on the device’s ongoing safety and performance.
  5. Recommendations for updates to the risk management file, IFU, or CER.

Why does PMCF matter?

Under EU MDR, manufacturers are expected to demonstrate ongoing compliance throughout the device lifecycle. PMCF Reports are not just regulatory paperwork—they are tools to:

  • Build trust with regulators, healthcare professionals, and patients.
  • Ensure early detection of risks.
  • Strengthen the clinical evidence base for a device.

In summary, the PMCF Report serves as the bridge between real-world use and regulatory compliance, ensuring that medical devices remain safe, effective, and reliable throughout their market life.

For more details, Contact RN Consulting Solutions MedTech Compliance Experts

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The EU AI Act: A New Era of Safe and Trustworthy Artificial Intelligence

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The EU Artificial Intelligence Act (AI Act) is the world’s first comprehensive AI regulation, aiming to ensure that AI systems placed on the EU market are safe, trustworthy, and respect fundamental rights. It was formally adopted in 2024 and will be fully applicable by 2026, with some provisions starting earlier. The AI Act contains 113 articles and 13 annexes.

Key Elements:

1. Risk-Based Approach:

  • Prohibited AI Systems: AI uses considered unacceptable risk (e.g., social scoring, manipulative subliminal techniques).
  • High-Risk AI Systems: Includes AI used in medical devices, critical infrastructure, law enforcement, etc. These are subject to stringent compliance requirements.
  • Limited-Risk AI: Requires transparency (e.g., chatbots must disclose they are AI).
  • Minimal-Risk AI: Most AI systems (e.g., spam filters) are not regulated under strict obligations.

2. High-Risk AI Obligations (Impacting MedTech & Software):

  • Risk management and quality management systems.
  • Data governance and dataset quality.
  • Logging, traceability, and record-keeping.
  • Transparency and user information.
  • Human oversight requirements.
  • Robustness, accuracy, and cybersecurity.
  • CE Marking under existing sectoral legislation (MDR/IVDR) is harmonized with AI Act requirements.

3. Specific Role Definitions:

  • Provider: Entity developing or placing the AI system on the market.
  • Deployer: User operating the AI system (could be hospitals, clinicians, etc.).
  • Importer/Distributor: Economic operators involved in supply chain responsibilities.

4. AI Regulatory Sandbox and Innovation Support:

  • Facilitates a controlled environment that allows AI system providers to develop, train, validate, and test their innovative AI technologies for a limited period under regulatory supervision.
  • SME-friendly approach to reduce regulatory burden for startups.

5. Governance and Enforcement:

  • National Competent Authorities and AI Office for harmonized enforcement.
  • High fines for non-compliance (fines of up to 35 000 000 EUR or up to 7 % of its total worldwide annual turnover, whichever is higher).

    Key take-aways:

    • Compliance with EU MDR/IVDR remains mandatory, but additional AI-specific obligations will apply.
    • Harmonized standards and MDCG guidance (e.g., MDCG 2025-6) will help in overlapping compliance pathways.

    Conclusion:

    The EU AI Act marks a groundbreaking step in ensuring that AI technologies are developed and deployed in a safe, transparent, and human-centric manner. By introducing a risk-based framework and aligning AI obligations with existing sectoral regulations like the MDR and IVDR, the Act sets a global benchmark for trustworthy AI. For businesses, especially in regulated sectors like healthcare, proactive preparation for compliance will not only ensure market access but also build long-term credibility and user trust in AI-driven innovations.

    For more details, Contact RN Consulting Solutions MedTech Compliance Experts

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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.

      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

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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

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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

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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

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