EU MDR Compliance Support for a Global Combination Product Manufacturer

Project Summary

A leading global combination product company partnered with Celegence for regulatory documentation support to ensure compliance with the EU Medical Device Regulation (MDR). The engagement covered multiple product families and classifications. Celegence’s regulatory experts prepared and revised Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Plans, and Summaries of Safety and Clinical Performance (SSCPs) for Class IIa and IIb device-led products. Working closely with the client’s regulatory team, Celegence delivered high-quality documentation on a fixed-fee basis, enabling the client to meet critical MDR deadlines efficiently.

Highlights:

Preparation and revision of CEPs, CERs, PMCF Plans, and SSCPs

Reviewing adequacy of clinical data across Class IIa and IIb products

Updating documentation based on notified body feedback

Providing end-to-end MDR documentation support within fixed-fee arrangements