CEP, CER and PSUR Consulting Support for a Global Medical Device Manufacturer​

Project Summary:

A global medical device manufacturer, which is a leader in next generation synthetic bone graft technologies for targeted and controlled bone healing wanted help with creating and updating MDD compliant CEP/CER and PSUR for class III orthopedic implantable and MDR compliant CEP/CER and PSUR for class III orthopedic implant.


The initial templates shared by the client were not MDR compliant and needed to be updated simultaneously while performing the Clinical Evaluation Plan (CEP)/Clinical Evaluation Report (CER) tasks to align with the most recent Notified Body (NB) comments and EU MDR requirements

Celegence Solution & Approach:

The Celegence expert team was engaged in the following activities:

  • Performed extensive literature searches for subject device and state of the art.

  • Updated the CEP/CER with the data each year for annual maintenance.

  • Came up with measurable benefits and endpoints and amend based on any new data.

  • Came up with safety and performance parameters for determining acceptability of benefit risk.

  • Determined the acceptance criteria for each parameter and benefit using data from State of the Art.

  • Updated the acceptance criteria based on new data availability.

  • Updated data relating to any new publications/ clinical studies/ PMCF data availability.

  • Conducted risk mapping of all events reported for subject and similar device in published literature, safety databases, manufacturer held data.

  • Facilitated review of the documents by a TA expert in line with the requirements of EU MDR.

  • Initiated annual maintenance activities as and when needed to align with the timelines and not deviate from SOPs as well as stated EU MDR requirements.

  • Provided finalized formatted word and PDF documents for signature and approval.

Project Outcomes

The key aspects of the project outcomes involved:

  • 1

    Timely delivery of required documents for NB review.

  • 2

    High quality documents with minimal feedback.

  • 3

    Expert review ensuring clinical aspects covered in line with EU MDR requirements.

  • 4

    Advisory consultation on PMCF adequacy and study models.

Project Success

Celegence provided valuable expertise and assistance throughout the regulatory process, helping the manufacturer maintain compliance and ensure the safety and efficacy of their orthopedic implantable devices.

Get in touch today to discuss your EU MDR regulatory needs by reaching out to info@celegence.com.