Continuous Clinical Evidence
Post-Market Clinical Follow-up (PMCF) is a continuous process that proactively collects and evaluates clinical data from devices in actual use. Under MDR and IVDR, PMCF is mandatory and must be planned, documented, and executed systematically.
RegOps provides comprehensive PMCF services from strategy development through execution and reporting. We design PMCF approaches proportionate to device risk that efficiently generate the clinical data regulators expect. Our PMCF strategies integrate with your post-market surveillance systems, ensuring clinical evidence collection complements vigilance activities and contributes to ongoing benefit-risk assessment. We help you transform PMCF from a compliance exercise into a source of clinical insights.
Our Capabilities
Full-cycle PMCF support from planning to reporting.
Creation of PMCF plans aligned with MEDDEV 2.12/2 and MDR Annex XIV Part B. We define objectives, methods, milestones, and acceptance criteria appropriate to your device.
Design of PMCF investigations including registries, surveys, and observational studies. We develop protocols that address clinical questions while remaining practical to execute.
Systematic literature surveillance to identify published clinical evidence. We establish review protocols, conduct periodic searches, and appraise data for PMCF integration.
Implementation of real-world evidence collection mechanisms including patient registries and EHR analysis. We design data collection to support regulatory and commercial objectives.
Authoring of PMCF evaluation reports that synthesize data, assess conformity to performance claims, and document conclusions regarding ongoing safety and performance.
Alignment of PMCF activities with clinical evaluation requirements, ensuring PMCF outputs support periodic CER updates and Notified Body assessments.
The RegOps Advantage
We design PMCF programs that generate clinically meaningful insights while satisfying strict regulatory requirements.
Proportionate Design
We scale PMCF activities appropriately to device risk and evidence gaps, neither under-investing nor over-engineering.
Practical Methods
We design data collection that works in clinical practice, considering site burden and patient engagement factors.
Regulatory Acceptance
Our PMCF plans and reports are developed with Notified Body expectations in mind, facilitating acceptance during assessment.
Clinical Value
Beyond compliance, we design programs that generate meaningful insights to support evidence-based claims and development.