PMCF

Clinical consistency, regulatory compliance, strategic control

Post-Market Clinical Follow-up (PMCF) is an integral part of Post-Market Surveillance (PMS) and represents the natural extension of a medical device’s clinical evaluation under the MDR. It’s a proactive, ongoing process built around a clear plan, designed to gather real-world clinical data on device use and confirm its safety, performance, and risk-benefit profile over time.

Under MDR, clinical data refers to any information on a device’s safety or performance in human use, consistent with its intended purpose and the manufacturer’s instructions.
PMCF is therefore not merely data collection: it is the process that ensures consistency, updates, and control over clinical documentation.

Why invest in PMCF

The PMCF plan and report, along with related activities, are a regulatory requirement introduced by the MDR. A robust PMCF framework goes far beyond meeting MDR requirements—it enables you to:

• Collect clinical evidence strategically to reinforce and sustain the clinical evaluation
• Demonstrate continuous compliance with MDR requirements
• Detect emerging risks early and proactively
• Ensure alignment between clinical evaluation, risk management and PMS
• Prevent the most frequent Non-Conformities identified by Notified Bodies

How our service works

Clariscience provides a PMCF service that is flexible, modular, and fully customizable, designed to align with the manufacturer’s specific regulatory and business needs.

Whether you require end-to-end management or support for selected phases, we adapt to your internal resources and strategic objectives to ensure compliance and efficiency.

PMCF plan

• Analysis of existing clinical documentation
• Support in defining activities to include (clinical studies, surveys, literature reviews)
• Preparation of the plan in full compliance with MDR and MDCG 2020-7 guidance

PMCF report

• Analysis of data collected through the PMCF activities defined in the manufacturer’s plan
• Conducting literature reviews and/or additional research as outlined in the PMCF plan
• Preparation of the report in full compliance with MDR requirements and MDCG 2020-8 guidance
• Assessment of the impact of findings on technical documentation, including actionable recommendations for updating the clinical evaluation and related documents

Related and integrable activities

• Support in designing, planning, and conducting proactive PMCF activities: preparation of documentation for clinical studies (learn more about this service), development and design of surveys or questionnaires (see our service Survey Evidence Builder), execution of literature searches
• Dataset creation and statistical analysis of data collected through planned PMCF activities

• Assistance in resolving any Non-Conformities raised by your Notified Body
• Updating the clinical evaluation based on PMCF findings
• Delivery of training sessions to enhance internal expertise and autonomy in managing PMCF documentation
• Support in defining strategic data collection aimed not only at fulfilling regulatory obligations, but also at meeting marketing and communication needs

Why choose Clariscience