EU MDR Template Creation for a Global Multinational Life Sciences Manufacturer

Project Summary

The client chose to leverage Celegence’s team of regulatory medical writers to create templates that ensured they were compliant with all EU MDR requirements. Utilizing our extensive expert network, we were able to complete the project in a cost-efficient and timely manner. The templates were expected to support multiple therapeutic areas (TAs) and assist authors of various levels of expertise with detailed instructions and guidance specific to stand-alone devices, drug-device combinations (DDC), and software as a medical device (SaMD).

The project included the development of CER, CEP, PMCF Plan, and PMCF Report templates to be used throughout the organization in the therapeutic areas of:

Celegence Solution & Approach:

Celegence partnered closely with the client to create templates with following key features:

Highlights:

Appropriate sections and subsections reflecting the requirements per the MDR, IMDRF, MDCG

Guideline based instructions for each section/subsection with brief examples as warranted

Detailed instructions for different scenarios as applicable

Standard text, editable examples, and instructional text in each section

Documents prepared in compliance with customer-specific style guide