Post-Market Surveillance and Post-Market Clinical Follow-Up (PMCF) Services for Medical Devices
Ensuring Long-Term Compliance and Patient Safety Under EU MDR and IVDR
The evolving European regulatory landscape, shaped by the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), places strong emphasis on post-market activities. Among these, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) are critical mechanisms to ensure that medical devices maintain an acceptable benefit-risk profile throughout their lifecycle.
PMS and PMCF are not isolated obligations, they are integral to clinical evaluation, risk management, and quality assurance processes. A structured and methodical approach to these activities is essential for ongoing conformity, transparency, and patient safety.
At GBA Group, we support manufacturers in implementing proactive, data-driven PMS and PMCF strategies that align with EU regulatory standards while enhancing device lifecycle management and clinical evidence generation.
Overview of Post-Market Surveillance
Post-Market Surveillance encompasses all activities carried out to systematically collect, evaluate, and respond to information related to the performance and safety of medical devices after they have been placed on the market. Key objectives include:
- Identification of emerging risks based on real-world data
- Verification of device performance under actual conditions of use
- Contribution to clinical evaluation updates
- Support for product improvements and corrective actions
- Fulfillment of regulatory reporting and documentation requirements
Manufacturers are required to implement and maintain a PMS system proportionate to the risk class and intended use of their devices. This includes the development of a PMS Plan and the generation of regular reporting outputs such as PMS Reports (PMSR) for Class I devices and Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices.
Role of Post-Market Clinical Follow-Up
PMCF is a continuous process within PMS, focused on updating clinical evidence post-market. Its purpose is to confirm the safety and performance of the device over time, identify unknown side effects, and ensure that the benefit-risk determination remains favorable. The need for PMCF and its specific methodology should be justified in the clinical evaluation, and the results should feed directly into ongoing risk management and surveillance processes.
Regulatory and Technical Considerations
An effective PMS and PMCF system should be integrated into the broader quality management system (QMS), aligning with ISO 13485:2016 and relevant MDCG guidance documents. Responsibilities should be clearly assigned, and processes must be designed to ensure traceability, timely reporting, and data integrity.
Key elements include:
- Data sources: complaints, incident reports, literature reviews, user feedback, registries
- Risk-based approaches to prioritizing surveillance activities
- Timely reporting of serious incidents and Field Safety Corrective Actions (FSCAs) to Competent Authorities
- Documentation readiness for notified body assessments and audits
Ongoing Challenges and Strategic Implementation
The implementation of PMS and PMCF systems presents several challenges, including managing data volume and variability, interpreting findings in a clinical context, and ensuring responsiveness to regulatory updates.
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