MDR Support for Flow Monitoring Devices
MDR Clinical Evaluation for Intimate Lubricant
Project Summary
A manufacturer of an intimate care product partnered with Celegence to support the transition of its legacy device from MDD to MDR, resulting in a change in risk classification from Class I to Class IIb. The engagement included the development and maintenance of clinical evaluation and post-market surveillance documentation, supporting CE marking and Notified Body (NB) reviews. Celegence prepared Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), PMCF Plans and Reports, PMS Plans, and PSURs to ensure compliance with EU MDR requirements.
Scope of Work
Celegence supported the client by :
Authoring CEP, CER, PMCF Plan, PMCF Report, PMS documentation, and PSURs.
Designing and executing PMCF surveys aligned with measurable endpoints derived from the State of the Art (SOTA).
Addressing limited legacy clinical data through a structured PMCF strategy.
Developing PMCF Reports demonstrating fulfillment of predefined acceptance criteria.
Incorporating survey questions to support comparisons with similar marketed products.
Preparing the initial MDR documentation package and responding to Notified Body queries to support CE marking.
Outcome
Achieved >98% quality and on-time delivery performance despite challenging timelines and limited source documentation.
Strengthened MDR compliance through expert regulatory guidance.
Successfully supported CE marking with well-structured clinical and PMS documentation.
Minimized Notified Body feedback through comprehensive responses and documentation updates.
Project Success
The success of this engagement was driven by Celegence's regulatory expertise, structured authoring approach, and close collaboration with the client's technical file team. Effective stakeholder coordination and strategic documentation development ensured strong alignment with MDR requirements while supporting efficient Notified Body reviews and timely CE marking.
Highlights
MDR transition from Class I to Class IIb
CEP, CER, PMCF, PMS, and PSUR development
PMCF survey design and execution
Clinical evidence generation for limited legacy data
Notified Body response and CE marking support
98% quality and on-time delivery performance
Need Clinical Evaluation and PMS Support for MDR Transition?
Celegence provides end-to-end regulatory support, including CEP, CER, PMCF, PMS, and NB response services to help manufacturers achieve MDR compliance with confidence. Email us at info@celegence.com
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29 May, 2026
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