Discover how a proactive PMCF strategy drives innovation, builds trust, and secures market leadership.
Transforming a regulatory necessity into a competitive edge begins with a proactive Post-Market Clinical Follow-up (PMCF) strategy. By going beyond compliance and actively gathering real-world clinical data, manufacturers can uncover valuable insights that inspire innovation, strengthen product performance, and address patient needs more effectively. This approach not only ensures MDR readiness but also builds long-term trust with healthcare professionals, patients, and regulatory bodies. Ultimately, a well-executed PMCF strategy becomes more than a legal requirement—it becomes a powerful driver of market leadership and sustainable growth
The Hierarchy of Responsibility
Global Regulatory Approaches
While both the EU and US prioritize safety, their philosophies differ, requiring a nuanced global strategy.
This chart illustrates the conceptual difference in regulatory burden. The EU MDR requires proactive PMCF for nearly all devices, while the FDA’s mandatory Section 522 studies are a more targeted intervention for specific high-risk devices.
Architecting a Defensible PMCF Program
A successful PMCF program is a continuous cycle of planning, execution, and analysis that feeds critical insights back into your device’s technical documentation
service related FAQ’s
Absolutely. We can take over PMCF activities for devices already CE-marked and on the EU market, ensuring that your data collection, evaluation, and reporting fully meet MDR requirements — even if your existing documentation needs corrective action before the next Notified Body audit.
The timeline varies based on device class and documentation readiness. Class I devices may take a few weeks, while Class IIa, IIb, and III devices requiring Notified Body review may take 6–12 months or more.
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
Absolutely. In addition to EC REP services, we offer end-to-end regulatory consulting, including Notified Body selection, technical file preparation, and gap analysis to support your CE Marking journey efficiently.
Some key documents include the Technical Documentation (Annex II & III), Clinical Evaluation Report (CER), Risk Management File, PMS/PMCF Plans, and labeling/instructions for use (IFU) compliant with GSPR
