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
No. Human Factors studies complement but do not replace clinical evaluation. They specifically assess device-user interaction, whereas clinical evaluation assesses clinical performance, safety, and benefits.
Form MD-22: This is the application form submitted to the Central Licensing Authority (CLA) (i.e., DCGI under CDSCO) to seek permission for conducting a clinical investigation of a new medical device or an investigational medical device without a predicate device in India.
Form MD-23: If the CLA is satisfied with the application, it grants permission to conduct the clinical investigation through Form MD-23. This permission allows the sponsor to begin the study in accordance with an approved clinical investigation plan reviewed by a registered Ethics Committee.
Additional requirements:
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The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant.
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The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.
All medical devices sold in England, Scotland, and Wales must be UKCA certified unless CE marked under special transition rules (valid until mid-2028 for some devices)
We offer fast onboarding, typically within 1–2 working days upon receipt of the necessary documentation and agreement. We also guide you through label updates and document handovers to ensure a smooth transition.
Yes. According to MDR and IVDR requirements, the EC REP’s name and address must be clearly visible on the product labeling, outer packaging, or accompanying documents, allowing EU authorities to easily identify the representative.
