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):
- Make a Follow-up Plan
Outline how you’ll keep checking safety and performance after launch.
- Collect Real-World Data
Use studies, surveys, or registry data to see how the device is performing in practice.
- Summarize Findings
Write a clear report on what you’ve learned.
- Feed Into Ongoing Monitoring
Update your safety files and risk assessments with the new evidence.
For IVDs (PMPF, IVDR):
- Make a Follow-up Plan
Define the key performance questions and how you’ll answer them.
- Gather Feedback and Evidence
Use clinician/patient surveys, data from labs, or long-term studies.
- Summarize Findings
Report on whether the IVD is performing as claimed and flag any new issues.
- 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
- Planning
- Review the CER/PER for gaps.
- Draft a PMCF/PMPF Plan.
- Define clinician performance questions and methods.
- Execution
- Collect proactive data from clinicians and patients.
- Conduct targeted surveys.
- Monitor emerging standards and comparator technologies.
- Evaluation
- Analyse real-world clinical/performance vs. claimed specifications.
- Identify new risks, limitations, or populations.
- Benchmark against state-of-the-art alternatives.
- 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.
- 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.