Post-Market Clinical Follow-up (PMCF) Surveys
Rigorous, regulator-ready PMCF survey programmes designed by medtech research specialists. From study design to final report, we generate the clinical evidence your Notified Body expects.
EU MDR 2017/745 · ANNEX XIV
What is PMCF — and why does it matter?
PMCF surveys are the most practical and cost-efficient route to generating this evidence — directly feeding your PMCF report, Clinical Evaluation Report (CER), and PSUR documentation.
Post-Market Clinical Follow-up (PMCF) is a mandatory, ongoing regulatory process for all CE-marked medical devices. It requires manufacturers to proactively collect and evaluate real-world clinical data to confirm the continued safety and performance of their device throughout its lifecycle.
A regulatory requirement — and a strategic asset
Under EU MDR 2017/745, Post-Market Clinical Follow-up is a mandatory, ongoing process for all CE-marked medical devices. PMCF surveys represent one of the most practical and cost-efficient routes to generating the real-world clinical evidence your technical documentation demands.
Beyond compliance, well-designed PMCF data provides genuine commercial intelligence — confirming device performance, identifying emerging risks early, and strengthening your benefit-risk case at each Notified Body audit.
EU MDR Article 61 & Annex XIV
PMCF is required for all device classes unless a scientific justification confirms it is unnecessary. For Class IIa, IIb, and III devices, and those approved via equivalence or with limited long-term safety data, PMCF surveys are typically the most appropriate evidence-generation activity.
PMCF surveys are particularly applicable where:
Clinical evidence from pre-market was generated via equivalence
The device uses novel or emerging technology
Long-term safety and performance data is limited
The device is used in high-risk or vulnerable patient populations
Your Notified Body has requested additional real-world evidence
Post-market surveillance has flagged unresolved safety signals
Two evidence levels. One specialist team.
LEVEL 4 EVIDENCE
Case-Specific Clinical Surveys
The highest-quality survey evidence under MDR. Completed per patient case by treating clinicians using medical records or charts.
Prospective or retro/prospective data collection
Minimises recall bias — reflects real clinical encounters
Supports device-level, variant & subgroup analysis
Accepted by TÜV SÜD, BSI and other leading NBs
Our Approach
End-to-end delivery, built around your device
From gap analysis to final regulatory report, medintel manages every stage. Each project is led by a dedicated research specialist with hands-on medtech experience.
Gap Analysis & Strategy
We review your PMCF plan and CER to identify clinical data gaps and define the optimal survey approach for your device and Notified Body.
Survey & Protocol Design
MDCG-compliant PMCF plan, questionnaire design, sample size determination, screener development, and SAS plan.
LEVEL 8 EVIDENCE
General End-User Surveys
A cost-effective, widely accepted method for lower-risk devices or as a complementary data source alongside higher-level evidence.
Retrospective HCP feedback on device experience
Rapid deployment — ideal for annual PMCF cycles
Validated questionnaire aligned with your PMCF plan
Suitable for Class I & IIa devices, legacy products
Fieldwork & Data Collection
Recruitment of authenticated HCPs, secure online data collection, ongoing quality checks, and response rate management throughout fieldwork.
Statistical Analysis
Full statistical analysis and data tables in line with your pre-specified SAS plan. Raw data quality auditing and clean dataset delivery.
PMCF Survey Report
MDCG 2020-8 compliant report, ready to integrate directly into your CER, risk management file, and PSUR documentation.
Why choose medintel for PMCF?
Specialist medtech expertise at every stage
Deep Therapeutic Area Knowledge
First-hand experience across cardiovascular, vascular intervention, surgical, orthopaedic, and diagnostic devices — we understand the clinical context behind every question.
Verified HCP Panels
Curated panels of authenticated healthcare professionals actively using your device type in clinical practice. Not generic pools — specialist respondents.
Regulator-Ready Documentation
Every deliverable structured to meet Notified Body expectations. Plans, reports, and statistical outputs accepted by BSI, TÜV SÜD, and other leading NBs.
Multinational Study Execution
Multilingual PMCF programmes across EU5 and beyond — translation, country-level recruitment, and local regulatory considerations in one coordinated project.
GDPR-First Data Governance
Informed consent, data traceability, anonymisation, and retention protocols aligned with ISO 14155:2020 — built in from study initiation.
Integrated Qualitative Capability
Where quantitative PMCF data raises questions, our in-house qualitative team adds HCP depth interviews — unique contextual insight no pure survey provider offers.
Compliance & Quality Standards
Built To Satisfy Notified Body Scrutiny
EU MDR 2017/745
Annex XIV PMCF requirements and MDCG 2020-7/8 guidance compliance throughout.
ISO 14155:2020
GCP-aligned data collection protocols for clinical investigations of medical devices.
GDPR & ICH-GCP
Informed consent, data minimisation, and traceability built in from study initiation.
Our quality management processes and documentation standards are benchmarked against MDCG guidance and validated through successful Notified Body submissions across multiple device types and risk classifications — including Class IIb and Class III devices.
IVDR 2017/746
PMPF survey services for IVD manufacturers meeting IVDR post-market obligations.
Let’s Work Together
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