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
Yes. Under EU MDR 2017/745, Post Market Clinical Follow Up is a mandatory and ongoing activity for all CE-marked medical devices, regardless of risk class. The extent of PMCF activities may vary depending on the device’s risk profile, clinical history, and available data.
Not always. If sufficient historical data or literature exists to demonstrate the safety of materials used in the device, some tests may be waived. A gap analysis helps determine whether existing data is adequate or if additional testing (e.g., cytotoxicity, irritation, sensitization) is required to meet regulatory expectations.
Its highly recommended to conduct testing of finished salable device before you apply for regulatory clearance.
Yes, we provide full support for UDI implementation and registration in compliance with EU MDR 2017/745 and IVDR 2017/746 requirements. Our team assists manufacturers in assigning and structuring UDI-DI and UDI-PI codes based on the device classification and intended use. We also help in ensuring proper placement of UDI on labeling, packaging, and Instructions for Use (IFU), as well as preparing for UDI module submission once it becomes fully functional within EUDAMED.
Our services cover:
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UDI-DI and UDI-PI structure guidance
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Compliance with GS1, HIBCC, or ICCBBA issuing agencies
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UDI label and packaging review
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Preparation for EUDAMED UDI/Device registration module
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UDI-related documentation for your Technical File and CE submission
By integrating UDI properly, we help ensure device traceability, reduce market delays, and support full regulatory compliance across the EU.
Foreign manufactures and exporters interested in selling medical devices in the USA can approach us. Our extensive knowledge of FDA regulations will aid in a smooth and efficient registration process. We the US Agents awake and answer any time when authorities ask for information. In addition to our US office, we have offices in Germany, India, Malaysia, UK and Vietnam.
We are not just like others, we have a big team of device experts, consultants and project managers who can handle any type of service to your organization.
The US Agent Service is vital for FDA medical device registration of foreign medical and in-vitro diagnostic devices manufacturers and initial exporters.
Yes we provide Food, Cosmetic, Drug and cosmetic label review service.
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
https://www.fda.gov/drugs/development-resources/labeling-information-drug-products
