PMCF Studies
When Post-Market Surveys aren't enough, structured clinical studies deliver the evidence Notified Bodies demand.
Expert Clinical Strategy Support for Medical Devices and IVDs
Expert Clinical Strategy Support for Medical Devices and IVDs
Post-Market Clinical Follow-up (PMCF)studies are mandatory for high-risk medical devices and IVDs under EU MDR2017/745 and IVDR 2017/746. Unlike basic PMCF surveys, formal PMCF clinical investigations provide Level 1-2 clinical evidence that satisfies Notified Body requirements for Class IIb, Class III, and implantable devices.
Qserve CRO conducted over 75 PMCF studies within different therapeutic areas. From cardio to implantable orthopedic devices, we do have significant experience and expertise. Designing scientifically rigorous PMCF studies that balance regulatory expectations and operational feasibility while avoiding the costly pitfalls of poor study design or insufficient data collection. We provide PMCF study services from protocol development through final reporting, ensuring your post-market clinical evidence strengthens your Clinical Evaluation Report (CER), supports CE Mark maintenance, and withstands regulatory scrutiny.
Our PMCF Study Services:
PMCF Strategy & Study Design
We define PMCF strategies and study designs aligned with your device risk class, claims, and residual risks, ensuring proportional and compliant evidence generation.
PMCF Study Protocol Development
We develop regulator-ready PMCF study protocols, including objectives, endpoints, methodologies, and data collection plans aligned with MDCG guidance.
Regulatory & Ethics Submissions
We support PMCF study submissions to ethics committees and competent authorities, ensuring timely approvals and regulatory alignment.
Site & Stakeholder Management
We identify and manage clinical sites, investigators, and stakeholders, coordinating study start-up, training, and ongoing communication.
Data Collection & Management
We oversee structured data collection, monitoring, and validation to ensure high-quality, traceable, and reliable PMCF data.
PMCF Study Reporting
We prepare comprehensive PMCF study reports that support your PMS system, clinical evaluation updates, and regulatory submissions.
Why PMCF Studies are critical for MDR & IVDR Compliance
Why PMCF Studies are critical for MDR & IVDR Compliance
MDCG 2020-6 and MDCG 2020-13 emphasize that PMCF is a continuous obligation. For many manufacturers, structured PMCF studies are the only way to:
✓ Close Clinical Evidence Gaps identified in your CER/Performance Evaluation Report (PER)
✓ Demonstrate Long-Term Safety & Performance for implantable and life-sustaining devices
✓ Validate Clinical Claims under real-world conditions of use
✓ Satisfy Notified Body Requirements during MDR/IVDR conformity assessments
✓ Support PSUR & Trend Reporting with objective, traceable clinical data
✓ Fulfill Article 61(4) MDR Requirements for Class III and implantable devices lacking sufficient clinical evidence
Key Regulatory Drivers:
- MDR Article 61 & Annex XIV Part B: PMCF obligations for ongoing clinical evaluation
- IVDR Annex XIII Part B: Performance evaluation update requirements
- ISO 14155:2020: Clinical investigation standards for medical devices
- MDCG 2020-7: PMCF Evaluation Report template and requirements
Ineffective PMCF studies can result in insufficient data or findings during audits and inspections. Poor study design or inadequate documentation often leads to increased costs and delayed regulatory acceptance.
Our structured, practical approach ensures your PMCF studies are operationally feasible. By aligning study objectives with clinical evaluation needs and proactively managing sites and data quality, we help you generate meaningful post-market evidence while maintaining control over timelines and resources.
Ineffective PMCF studies can result in insufficient data or findings during audits and inspections. Poor study design or inadequate documentation often leads to increased costs and delayed regulatory acceptance.
Our structured, practical approach ensures your PMCF studies are operationally feasible. By aligning study objectives with clinical evaluation needs and proactively managing sites and data quality, we help you generate meaningful post-market evidence while maintaining control over timelines and resources.
Still have questions? We are here to help, including with clinical strategy support.
What is the difference between a clinical investigation and a PMCF study?
A clinical investigation is typically conducted pre-market to establish safety and performance, while a PMCF study is conducted post-market, designed to gather real-world data and fulfill EU MDR requirements.
Are PMCF studies mandatory under EU MDR for all medical devices?
Under EU MDR, PMCF studies are required unless sufficient clinical evidence already exists, particularly for higher-risk and innovative medical devices.
How does Qserve support ISO 14155-compliant clinical trials?
Qserve provides full-service support for clinical trials aligned with ISO 14155. Our experts have many years of experience to ensure the execution of compliant studies, and using proven eTMF, CTMS and EDC software to maintain full transparency and recording of all documentation.
What types of data can be collected through a medical device registry?
Registries collect long-term safety, performance, and usage data, supporting post-market surveillance, PMCF, reimbursement strategies, and clinical improvement.
How long does it take to prepare and start a clinical investigation?
Timelines vary, but with Qserve’s support in protocol development, ethics submission, and project management, studies can be ready for initiation in a matter of months.