Comprehensive PMCF Support for Class I, IIa and IIb Legacy Medical Devices
Clinical Evaluation for Neurovascular Guide Catheters
Project Summary
A manufacturer of Class III neurovascular guide catheters partnered with Celegence for end-to-end regulatory support covering both new product CE marking and lifecycle maintenance activities. The engagement included preparation and maintenance of Clinical Evaluation Plans (CEPs) and Reports (CERs), Literature Search Reports (LSRs) to support U.S. submissions, and updates to SSCPs and PSURs. Celegence also supported responses to Notified Body (TÜV SÜD) comments and audit activities, ensuring compliance with EU MDR requirements across multiple products.
Scope of Work
Celegence supported the client by :
Authoring CEPs and CERs and reviewing LSRs, SSCPs, and PSURs.
Preparing LSRs with reference packs and curated literature to support U.S. marketing submissions.
Proposing Post Market Clinical Follow-up (PMCF)
Coordinating with clinical sites to collect interim data for CER inclusion.
Assessing clinical data adequacy using product-specific information, pre-clinical and clinical studies, adverse events, and literature.
Conducting comprehensive isk analysis of high-volume adverse event datasets.
Evaluating PMCF requirements and activity adequacy.
Developing State of the Art (SOTA) reviews to establish safety and performance benchmarks.
Supporting responses to TÜV SÜD Notified Body comments and audit activities.
Outcome
Celegence enabled a smooth and compliant documentation process, resulting in :
98% quality and on-time delivery performance, even under accelerated timelines.
Improved regulatory compliance through expert consultation.
Successful CE marking for a new product with limited clinical evidence.
Clearance of TÜV SÜD Notified Body comments in a single review cycle.
Real-time audit support, including rapid document updates and CAPA closure within 24 hours.
Project Success
The success of this engagement was driven by Celegence’s ability to operate as a seamless extension of the client’s regulatory team. Expert-led clinical evaluation strategies, rapid document turnaround, and continuous availability during audits ensured timely resolution of Notified Body feedback and sustained MDR compliance.
Highlights
Clinical evaluation support for Class III neurovascular guide catheters
CEP, CER, LSR, SSCP, and PSUR authoring and review
PMCF strategy development and data analysis
SOTA development and large-scale AE risk analysis
TÜV SÜD Notified Body response and audit support
CE marking achieved for products with limited clinical data
Need Clinical Evaluation Support for High-Risk Devices?
Celegence delivers expert-driven CEP, CER, PMCF, and NB response support for Class III and complex medical devices—helping manufacturers meet EU MDR requirements with confidence. 📧 Email us at info@celegence.com
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20 Jan, 2026
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