Global PMS and HCP-Based PMCF Survey Support for Aesthetic Surgery Devices
Initial CE Marking and Ongoing PMS Support for a Class III Radioactive Medical Device
Project Summary
A manufacturer of a Class III radioactive medical device required comprehensive regulatory support to secure initial CE marking and maintain ongoing compliance with the EU Medical Device Regulation (EU MDR).
Celegence was engaged to develop and implement a Post-Market Surveillance (PMS) strategy, including Post-Market Clinical Follow-up (PMCF) planning, Periodic Safety Update Report (PSUR) development, and regulatory documentation support.
The engagement extended beyond initial certification to include annual surveillance audits and long-term regulatory maintenance.
Scope of Work
Celegence provided end-to-end regulatory support across the device lifecycle, including :
Equivalence justification: Identified a suitable equivalent device to support clinical data bridging where device-specific literature was limited.
Safety and performance objectives: Developed EU MDR-aligned clinical safety and performance objectives and mapped them to PMCF activities.
Standards and testing support: Assisted in identifying applicable standards and testing requirements for conformity assessment.
Notified Body interactions: Responded to Notified Body queries to address feedback and minimize initial rejection and additional review cycles.
PMCF planning and execution: Developed cost-effective, risk-based PMCF plans, PSURs, and PMCF evaluation reports.
Audit and annual maintenance: Supported annual surveillance audits over three consecutive years, including SOP development for trending, data capture, and analysis.
Outcome
Initial CE marking achieved: Secured CE marking with minimal rounds of Notified Body feedback.
Ongoing regulatory compliance: Supported continued EU MDR compliance and surveillance audit readiness.
Timely regulatory submissions: Met tight Notified Body submission deadlines while exceeding the client's quality expectations.
Strategic PMCF execution: Implemented risk-based PMCF activities aligned with regulatory expectations and the client's budget.
Project Success
The success of this engagement was driven by close collaboration between Celegence's experienced regulatory professionals and the manufacturer's internal team. By bringing together clinical evaluation expertise, PMS strategy, regulatory documentation, and Notified Body interaction support, Celegence enabled responsive, high-quality document development throughout the engagement. This cross-functional approach helped the manufacturer achieve initial CE marking, maintain ongoing regulatory compliance, and manage annual surveillance activities while minimizing delays and cost overruns.
Highlights
Class III radioactive medical device
Initial CE marking under EU MDR
Clinical equivalence justification
PMS strategy and PMCF planning
PSUR and PMCF evaluation report development
Notified Body query and submission support
Three consecutive years of surveillance audit support
Ongoing regulatory documentation maintenance
Need Support with EU MDR Certification and Ongoing Compliance?
Celegence helps medical device manufacturers prepare for initial CE marking, establish risk-based PMS and PMCF strategies, address Notified Body queries, and maintain regulatory documentation throughout the device lifecycle.
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13 Oct, 2026
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