PMCF & PMS Services for Medical Devices|EU MDR| Bioexcel

EU MDR–compliant PMCF and PMS services for medical devices. Post-market clinical follow-up, PMS plans, reports, and lifecycle compliance support.

PMCF & PMS Services for Medical Devices

Bioexcel provides EU MDR–compliant Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS) services to support continuous clinical evidence generation and lifecycle compliance for medical devices. Our approach aligns with EU MDR Articles 83–86 and Annex III, ensuring audit-ready post-market documentation.

What Are PMS and PMCF Under EU MDR?

Under EU MDR, manufacturers must establish and maintain a systematic PMS system, with PMCF forming a key component for generating ongoing clinical evidence.

  • PMS monitors device safety and performance in real-world use
  • PMCF proactively collects clinical data to confirm safety, performance, and benefit-risk over time

Bioexcel supports both activities in an integrated, regulator-aligned manner.

Our PMCF & PMS Capabilities

We support manufacturers across all device risk classes and clinical categories.

PMCF & PMS Services Include:

  • PMS Plan and PMS Report (PMSR) development
  • PMCF Plan and PMCF Evaluation Report
  • PMCF surveys and registry-based studies
  • Real-world data (RWD) collection strategies
  • Trend analysis and signal review support
  • PSUR support (where applicable)
  • Integration of PMS & PMCF outputs into CER updates

EU MDR & Regulatory Alignment

All PMS and PMCF activities are aligned with:

  • EU MDR Articles 83–86
  • EU MDR Annex III
  • ISO 14971 risk management integration
  • ISO 13485 post-market requirements

Our documentation is structured to withstand Notified Body review and audits.

PMS, PMCF & Clinical Evaluation Linkage (CRITICAL)

Bioexcel ensures strong lifecycle integration between:

  • PMS / PMCF ↔ Clinical Evaluation (CER)
  • PMCF ↔ Real-World Evidence (RWE)
  • PMCF ↔ Clinical Investigations (where required)

This approach ensures:

  • Continuous clinical evidence
  • Reduced NB questions
  • Sustainable MDR compliance
  • Clinical Evaluation Report (CER)
  • Real-World Evidence (RWE)
  • Clinical Investigation Services

Digital Enablement with Vigi X™

Bioexcel leverages Vigi X™, our materiovigilance and post-market compliance platform, to support PMS and PMCF activities

Vigi X™ Supports:

  • Complaint intake and assessment
  • Incident evaluation and reportability decisions
  • PMS data aggregation and trend analysis
  • PMCF data integration
  • Audit-ready post-market documentation
  • Vigi X™ Materiovigilance Platform

When Do You Need PMCF & PMS Services?

  • CE marking under EU MDR
  • Legacy device MDR transition
  • Periodic CER updates
  • NB findings related to post-market data
  • Significant design or risk profile changes

Why Bioexcel for PMCF & PMS?

  • Dedicated focus on medical devices & MDR compliance
  • Strong understanding of NB post-market expectations
  • Seamless integration with CER, RWE &
  • Structured, inspection-ready deliverables