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
All medical device manufacturers intending to sell devices in the EU, including Class I, IIa, IIb, and III must comply with the MDR.
Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.
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.
Yes. If your company is based outside the EEA and wishes to market medical devices or IVDs in Europe, it is legally required to appoint an EC REP. This representative’s name and address must appear on the product labeling, outer packaging, or Instructions for Use (IFU).
Key standards include:
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ISO 62366-1 – Usability engineering for medical devices.
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ISO 14971 – Risk management for medical devices.
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IEC 60601-1-6 – Usability requirements for medical electrical equipment.
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ISO 20916 – Performance studies for IVDs.
