Strengthening Post-Market Intelligence - How IDR Medical Can Support

We help Medical Device (MD) and In Vitro Diagnostic (IVD) manufacturers go beyond box-ticking compliance in Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF). By designing and executing robust real-world studies and surveys, we provide evidence that is both regulator-ready and strategically valuable for market access, positioning, and adoption.

How IDR Medical Supports Manufacturers with PMCF & PMPF Under EU MDR/IVDR

The EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have transformed post-market expectations. Beyond CE-marking, manufacturers are now required to continuously monitor how their devices perform in real-world use.

At IDR Medical, we help clients navigate:

• Post-Market Clinical Follow-Up (PMCF) for medical devices under MDR.
• Post-Market Performance Follow-Up (PMPF) for IVDs under IVDR.

We turn compliance obligations into actionable intelligence that supports safety, effectiveness, and commercial strategy. Find out more.

What is PMCF / PMPF?

PMCF (Medical Devices, MDR):

• Continuous process of collecting and evaluating clinical data on CE-marked medical devices.
• Objectives: confirm safety and clinical performance claims, identify risks/off-label use, and update benefit-risk profile.
• Feeds into the Clinical Evaluation Report (CER) and PMS system.

PMPF (IVDs, IVDR):

• Continuous process of collecting and evaluating performance data on CE-marked IVDs.
• Objectives: confirm analytical/clinical performance claims, identify risks or new populations, and update benefit-risk profile.
• Feeds into the Performance Evaluation Report (PER) and PMS system.

What Manufacturers Must Do

For Medical Devices (PMCF, MDR):

1. Make a Follow-up Plan
   Outline how you’ll keep checking safety and performance after launch.
2. Collect Real-World Data
   Use studies, surveys, or registry data to see how the device is performing in practice.
3. Summarize Findings
   Write a clear report on what you’ve learned.
4. Feed Into Ongoing Monitoring
   Update your safety files and risk assessments with the new evidence.

For IVDs (PMPF, IVDR):

1. Make a Follow-up Plan
   Define the key performance questions and how you’ll answer them.
2. Gather Feedback and Evidence
   Use clinician/patient surveys, data from labs, or long-term studies.
3. Summarize Findings
   Report on whether the IVD is performing as claimed and flag any new issues.
4. Feed Into Ongoing Monitoring
   Update your performance reports, safety updates, and risk files regularly.

 Timing and Approach

• Immediate and continuous after CE-marking.
• Risk-based focus: higher-risk devices/IVDs demand more robust evidence.
• Integrated with QMS (ISO 13485, ISO 20916, ISO 14155 for MD studies).
• Must be documented, auditable, and regulator-ready.

Practical Post-Market Surveys Checklist

1. Planning

• Review the CER/PER for gaps.
• Draft a PMCF/PMPF Plan.
• Define clinician performance questions and methods.

2. Execution

• Collect proactive data from clinicians and patients.
• Conduct targeted surveys.
• Monitor emerging standards and comparator technologies.

3. Evaluation

• Analyse real-world clinical/performance vs. claimed specifications.
• Identify new risks, limitations, or populations.
• Benchmark against state-of-the-art alternatives.

4. Reporting

• Prepare PCFF Evaluation Reports (PMPF-ER).
• Update the CER/PER, PMS Report/PSUR, and Risk Management File.
• Ensure outputs are audit-ready for Notified Body review.

5. Continuous Improvement

• Adjust PMCF/PMPF plan to address new gaps.
• Train staff and align with QMS.
• Leverage findings for both compliance and market advantage.

How IDR Medical Supports Clients

We help manufacturers move beyond box-ticking compliance by offering:

Strategic Planning Support

• Help manufacturers translate clinical evaluation gaps into concrete PMCF objectives.
• Advise on which methods fit best (surveys, registries, observational studies, literature reviews).
• Build justifications for why chosen methods are sufficient to address clinical questions.

Methodology and Design

• Develop protocols for user / patient surveys, structured interviews, or observational follow-ups.
• Create validated questionnaires and data-collection tools that align with MDR Annex XIV requirements.
• Ensure methodologies meet standards of scientific rigor (sample design, bias mitigation, statistical plan).

Execution

• Conduct multi-country, multi-stakeholder studies (clinicians, patients, purchasers).
• Leverage access to hospitals, KOL networks, and registries for real-world data collection.
• Perform structured literature reviews and integrate findings into the PMCF evidence base.
• Implement longitudinal follow-ups with clinicians or patients to track device performance in routine practice.

Analysis and Interpretation

• Provide statistical analysis of PMCF datasets (safety signals, performance KPIs, PROs).
• Benchmark against competitor devices and standard of care.
• Identify early warning trends from qualitative insights (e.g., handling issues, usability, off-label use).

Reporting & Ongoing Partnership

• Translate findings into actionable recommendations that clarify implications for safety, performance, and regulatory compliance.
• Not just “one-off projects” we help clients set up sustainable PMCF programs with repeat surveys, registry feeds, and periodic updates.
• Act as a strategic insight partner so PMCF work drives value beyond compliance (e.g. market positioning, messaging, training materials).

At IDR Medical, our enhanced Post-Market Clinical Follow-Up (PMCF) and Post-Market Performance Follow-up (PMPF) capabilities empower medical device and IVD manufacturers to not only meet EU MDR/IVDR obligations, but also leverage post-market intelligence to drive continuous improvement, innovation, and competitive advantage.

See an example of our PMCF work in action in this case study on a new NPWT system:

Contact us today for a free, no-obligation consultation and start turning market insights into strategic advantage.