PMCF Post-Market Clinical Follow-Up Under MDR
Collect real-life clinical data to confirm your medical device performance and safety claims. Our expert team ensures ethically and scientifically valid, ISO 14155 compliant data generation to maintain your device on the market.
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Key Changes Under MDR
Understanding the strengthened PMCF requirements under the Medical Device Regulation
Strengthened Requirements
Specific PMCF requirements now included directly in the regulation text, not just guidance documents
Required Elements
Comprehensive PMCF plan requirements with defined objectives and methodologies
Clinical Data Collection
Specified methods and procedures for systematic clinical data collection
Objective Definition
Clear statement of PMCF objectives and expected outcomes for device performance
Our PMCF Services
Comprehensive post-market clinical follow-up solutions tailored to your needs
PMCF Studies
High-quality Level 4 PMCF studies with prospective, retrospective, and hybrid trial designs
Registry Studies
Product-specific and national registry implementations with comprehensive data collection
Patient Surveys
Systematic patient and healthcare professional surveys for real-world evidence
Expert-led methodology ensuring compliance and quality at every stage
Our Approach
Expert-led methodology ensuring compliance and quality at every stage
Led by Former Notified Body Leadership
Our team comprises former notified body and competent authority leaders who have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF.
They were instrumental in developing the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR.
Objectives of Our PMCF Studies
Confirm safety and performance throughout the device's expected lifetime
Identify and analyze emergent risks based on factual evidence
Ensure continued acceptability of the benefit-risk ratio under MDR
Identify systematic misuse or off-label use to verify intended purpose
Comprehensive post-market clinical follow-up solutions tailored to your needs
Why Choose Bioexcel
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Book a 15-minute free consultation to discuss your PMCF requirements
