PMCF / PMPF Surveys

PMCF surveys are appropriate when your device has substantial pre-market clinical data and you need to confirm long-term safety and performance, monitor residual risks, or gather real-world evidence. Full clinical investigations are typically required for novel devices, Class III implantables with limited clinical history, or when a survey cannot adequately address identified clinical gaps. Our gap assessment recommends the most appropriate approach for your situation.

Sample size is determined from the primary endpoints, expected effect sizes, and the statistical power required to detect clinically meaningful differences. We use established methods for proportions (safety and performance rates) or means (continuous outcomes), and exact binomial methods for rare adverse events. All calculations are documented with justification in the protocol and reviewed by our biostatistics team.

It varies by country and survey design. Surveys involving only healthcare professionals about their clinical experience may not require ethics approval, whereas surveys collecting patient-reported outcomes, accessing patient records, or involving direct patient participation typically require ethics-committee review. We assess the requirements for each target country and manage the submission process.

Level 4 evidence (per MDCG 2020-6) consists of structured surveys collecting patient-specific clinical outcomes, safety data, and performance metrics with proper methodology. Level 8 evidence is general user feedback or opinion without structured methodology — increasingly rejected by Notified Bodies as insufficient. Our surveys are designed specifically to generate Level 4 evidence that addresses your device's residual risks.

Timelines depend on scope, sample size, and geographic reach. A focused single-country HCP survey typically takes 3–4 months from protocol finalization to final report; multi-country patient-outcome surveys may require 6–9 months. Our established HCP network enables faster recruitment than building site relationships from scratch — often reducing timelines by up to 40%.

Yes — this is one of the most common use cases. Many devices certified under MDD have limited clinical data that doesn't meet MDR Article 61 requirements. PMCF surveys can efficiently generate real-world evidence on safety, performance, and clinical benefit to bridge these gaps, often more cost-effectively than retrospective clinical studies. We design surveys that directly address the gaps identified in your Clinical Evaluation Report.

We use CFR Part 11 and ISO 14155 compliant Electronic Data Capture (EDC) systems with audit trails, electronic signatures, and data-integrity controls. Real-time data-quality monitoring enables early issue identification, and all systems meet the standards Notified Bodies expect for clinical data capture.

We implement multiple validation mechanisms: HCP verification against professional registries, response-consistency checks, statistical outlier detection, and response-time analysis. For patient surveys, we use verified recruitment pathways through treating physicians. All methodologies are documented in the protocol for regulatory transparency.