Case Study: EU MDR Template Creation for a Global Multinational Life Sciences Manufacturer

Background – Client Needs:

A global multinational life sciences manufacturer required support for developing their templates, the Clinical Evaluation Plans (CEP), Clinical Evaluation Report (CER), Post-Market Clinical Follow-up (PMCF) Plan, and Post-Market Clinical Follow-up (PMCF) Report in compliance with the EU MDR. Additionally, to promote global convergence, the clinical evaluation was also compliant to relevant guidance documents from the Medical Device Coordination Group (MDCG) and the International Medical Device Regulators Forum (IMDRF) requirements for their product portfolio.

Project Initiation & Key Objectives:

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:

  • Ophthalmology
  • Pulmonology
  • Dermatology

Celegence Solution & Approach:

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

  • 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

Key EU MDR Template Achievements:

  • Templates with comprehensive and detailed instructions and guidance for the user where necessary
  • Cautions to the user for limiting information pertaining to drugs, in the case of combination products
  • Contents developed from Notified Body (NBs) perspective for DDC and SaMD
  • Developed customer’s new SOPs for compliant clinical evaluation and PMCF

  • 100% quality & timeline delivery performance despite tight timelines, an achievement due to the collaboration with Celegence’s expansive expert network

EU MDR Template Outcomes:

Key to the success of this partnership was involving experts and experienced resources with a comprehensive understanding of our customer’s requirements, resulting in quicker turnaround times and increased template usability.

Celegence has a wealth of knowledge to help you navigate through the complex regulatory challenges brought forth by the EU MDR. We can assist you throughout the entire process to ensure that you and your business are compliant with all EU MDR requirements.

If your organization needs support in developing templates to complete the PMCF plan and clinical evaluation plans and reports, reach out to our expert medical writing team at info@celegence.com or find out more information on Celegence’s Medical Device capabilities

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