Securing EU Approval for a First-Time Marketed Product
PMS Documentation for Software-Based Cardiovascular Imaging and Planning Tools – Audit & CE Marking Support
Project Summary
Support was provided for the initial MDR Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for software as a medical device (SAMD) in the cardiovascular therapeutic area. This included input on other PMS documents and SOPs required for CE marking, notified body (NB) audit, and certification. The engagement began under MDD, with successful certification, and later transitioned to MDR-compliant CERs. Celegence also supported recertification processes when significant updates or version changes occurred. Additionally, Celegence provided regulatory support for a Class IIb neurovascular SAMD device. This included preparation of the MDR-compliant CEP and CER for initial CE marking and addressing NB queries, which resulted in minimal questions and a successful certification outcome.
Celegence Solution & Approach:
Celegence supported the company for the following activities:
Highlights:
Authored MDR-compliant CEPs and CERs as well as initial MDD documentation for various cardiovascular imaging and planning SAMD products
Conducted gap analyses of existing PMCF and clinical data; addressed clinical evaluator and NB comments comprehensively
Identified suitable equivalent devices to enable data bridging; supported significant software version updates and NB recertification
Supported technical file updates, NB responses, and acted as the Authorized Representative (AR)
Developed a robust State-of-the-Art (SOTA) review with validated thresholds for safety and performance
Identified measurable, patient-relevant endpoints based on SOTA and demonstrated fulfillment of objectives with limited available data
Executed PMCF activities and integrated the findings into CE marking documentation
Delivered high-quality annual document updates under tight deadlines
Represented the company as SME consultants during NB meetings to justify clinical strategies and evidence
Project Achievements
Delivered high-quality regulatory documentation on time across multiple simultaneous projects
Achieved CE marking for both novel and legacy cardiovascular SAMDs
Gained NB acceptance for equivalence strategy, statistical justifications, and PMCF approaches
Closed non-conformities (NCs) and obtained approval for updated documentation following NB feedback
Successfully navigated NB reviews even in the absence of robust subject device data
Supported an additional neurovascular SAMD through initial MDR CEP/CER development with minimal NB questions and successful certification
Project Success
Success was rooted in Celegence’s ability to run multiple complex projects simultaneously while collaborating closely with client teams. A combination of strong regulatory expertise, in-depth product knowledge, strategic stakeholder communication, and real-time responsiveness ensured that deliverables met both NB expectations and internal timelines with minimal rework or delay..
Need MDR Documentation Support for Cardiovascular or Neurovascular SAMDs?
Celegence delivers MDR-compliant CEPs, CERs, PMCF support, and audit readiness for software-based medical devices—backed by expert guidance and minimal NB rework. Email us at info@celegence.com
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14 Aug, 2025
08 Aug, 2025
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