Regulatory Submission Support for Catherter and Guidewire
EU MDR Compliant Templates for a Multinational Pharmaceutical Company
Project Summary
A multinational pharmaceutical company partnered with Celegence to develop standardized templates for Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) Plans, and PMCF Reports. The objective was to create EU MDR- and IMDRF-compliant templates that could be used consistently across the organization and multiple therapeutic areas, including Ophthalmology, Respiratory, and Dermatology.
Scope of Work
Developing CEP, CER, PMCF Plan, and PMCF Report templates for organization-wide use
Designing templates to support multiple therapeutic areas and authors with varying levels of regulatory experience
Structuring documents with appropriate sections and subsections aligned to MDR, IMDRF, and MDCG requirements
Providing clear, guideline-based instructions for each section, including examples where applicable
Including scenario-specific guidance, common editable text, and instructional content
Ensuring all templates complied with the client’s internal style guide
Project Deliverables
MDR- and IMDRF-compliant CEP, CER, and PMCF templates
Designed for use across Ophthalmology, Respiratory, and Dermatology
Clear author guidance and instructional content
Notified Body-focused structure and expectations
Alignment with new internal SOPs
Project Achievements
Detailed user guidance to support consistent and accurate document development
Clear cautions to limit medicinal content for combination products
Content developed from a Notified Body perspective, including considerations for DDC and SaMD
Alignment with the client’s new SOPs for clinical evaluation and PMCF activities
Project Success
The success of this engagement was driven by the involvement of experienced regulatory experts who worked closely with the client and fully understood internal requirements. This ensured efficient development, faster turnaround times, and high user acceptance across teams.
Need Standardized MDR-Compliant Templates for Your Organization?
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18 Dec, 2025
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