Post-Market Surveys

In the evolving landscape of the EU medical device and IVD regulations (MDR and IVDR), Post-Market Surveys are more than a regulatory requirement, it's a strategic asset. At IDR Medical, we specialize in converting real-world performance data into actionable insights that not only ensure compliance but also enhance market positioning and adoption.

Understanding PMPF

PMPF is a continuous process mandated by MDR and IVDR, requiring manufacturers to:

• Verify: Confirm the scientific validity, analytical, and clinical performance claims made pre-market.

• Monitor: Identify emerging risks, off-label uses, or new patient populations.

• Maintain: Ensure a positive benefit-risk profile throughout the device's lifecycle.

These activities feed into the Performance Evaluation Report (PER) for IVDs or the Post-Market Clinical Follow-up (PMCF) report for medical devices, as part of the broader Post-Market Surveillance (PMS) system.

IDR Medical's Approach to Post-Market Surveys

We assist manufacturers of medical devices and IVDs transform PMPF from a compliance task into a strategic advantage through:

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).

PMPF/PMCF Checklist

To facilitate your post-market activities, we offer a practical checklist covering:

1. Planning: Reviewing PER/PMCF documentation, drafting the PMPF/PMCF Plan, and defining performance questions.

2. Execution: Collecting data from clinicians and patients, conducting surveys, and monitoring standards.

3. Evaluation: Analyzing real-world performance, identifying new risks, and benchmarking alternatives.

4. Reporting: Preparing PMPF Evaluation Reports or PMCF reports, updating regulatory documents, and ensuring audit readiness.

5. Continuous Improvement: Adjusting the plan, training staff, and leveraging findings for strategic advantage.