Initial CE Marking and Ongoing PMS Support for a Class III Radioactive Medical Device
EU MDR Clinical Evaluation Remediation for Class III Orthopedic Implant Devices
Project Summary
A leading manufacturer of orthopedic implant products partnered with Celegence to remediate clinical evaluation documentation following Notified Body (NB) feedback.
The engagement focused on updating Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Summaries of Safety and Clinical Performance (SSCPs) for Class III medical devices, addressing Notified Body observations and aligning documentation with EU MDR expectations.
Celegence combined clinical evidence assessment, regulatory consulting, medical writing expertise, and its CAPTIS® platform to support high-quality documentation and regulatory timelines.
Scope of Work
Celegence supported the manufacturer through :
CEP, CER, and SSCP remediation: Updating clinical evaluation and safety documentation in response to Notified Body feedback and EU MDR requirements.
Clinical evidence assessment: Evaluating the adequacy of available clinical evidence from medical device registries, clinical studies, published literature, complaints, and adverse-event information.
Risk identification: Assessing new or emerging clinical risks based on available safety and performance information.
Notified Body response support: Addressing observations and developing corrective responses to findings raised during NB audits and reviews.
Regulatory consulting: Providing strategic guidance and supporting communication with the Notified Body.
Outcome
Remediated CEPs, CERs, and SSCPs addressing Notified Body feedback and EU MDR expectations.
Enabled the manufacturer to meet regulatory deadlines with high-quality clinical documentation.
Delivered focused regulatory consulting and strategic support for Notified Body communication.
Improved compliance through guidance from Celegence's regulatory experts.
Project Success
The success of this engagement was driven by the integration of expert-led clinical documentation remediation, strategic regulatory consulting, and streamlined collaboration supported by Celegence's CAPTIS® platform. By assessing Notified Body observations alongside available clinical and safety evidence, Celegence helped the manufacturer strengthen its documentation, address identified gaps, and align its clinical evaluation approach with EU MDR and Notified Body expectations.
Highlights
Class III orthopedic implant devices
CEP, CER, and SSCP remediation
Notified Body observations and audit response support
Clinical evidence and risk assessment
CAPTIS®-supported collaboration
EU MDR clinical documentation alignment
Need Support Addressing Notified Body Findings?
Celegence helps medical device manufacturers assess and remediate clinical evaluation deficiencies, strengthen clinical evidence, and prepare responses to Notified Body observations.
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14 Oct, 2026
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