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
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.
The drug Master Files are divided into 4 Types
Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III: Packaging Material
Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V: FDA Accepted Reference Information
We provide US Agent service and E copy submission service. We also help with DMF preparation.
All medical device manufacturers intending to sell devices in the EU, including Class I, IIa, IIb, and III must comply with the MDR.
As part of our commitment to regulatory compliance and risk management, we recommend that all non EU manufacturers have valid Product Liability Insurance when appointing us as their European Authorized Representative (EC REP). While it is not a legal requirement under MDR/IVDR for the EC REP to request proof of insurance, many Competent Authorities and Notified Bodies may inquire about the manufacturer’s liability coverage during inspections or audits. Having proper insurance also demonstrates due diligence and protects your business in the event of product-related claims in the European market. We do not provide insurance ourselves, but we can guide you on what to include based on your device risk class and market exposure.
