Comprehensive CER Services for Medical Device Compliance
At Bioexcel, we provide end-to-end support for preparing and updating Clinical Evaluation Reports (CERs) in compliance with EU MDR (2017/745), FDA, and global regulatory requirements. Our expertise ensures your medical device meets safety, performance, and clinical evidence requirements, paving the way for seamless regulatory approvals and market entry.
What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a regulatory document required to demonstrate the safety and performance of a medical device using clinical data. Under EU MDR, CERs must be prepared and updated regularly to maintain CE marking and market access.
Key Components of a CER:
Comprehensive CERs Aligned with EU MDR
We prepare complete CERs based on your device’s risk classification, intended use, and clinical evidence requirements.
Key Features:
Ensuring Continuous Compliance
We perform gap analyses of existing CERs to identify deficiencies and update them to meet the latest regulatory requirements.
Key Features:
Robust Evidence for Regulatory Approval
Our team conducts systematic literature reviews to identify relevant clinical data and evaluate its applicability to your device.
Key Features:
Comprehensive Assessment of Safety and Performance
We assess the clinical benefits of your device against potential risks, ensuring alignment with ISO 14971 and EU MDR Annex I.
Key Features:
Seamless Submissions for Global Approvals
We provide regulatory-ready CERs and assist with submissions to Notified Bodies, FDA, CDSCO, and other authorities.
Key Features:
Ensuring Long-Term Compliance
We align your CER with Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities to maintain ongoing compliance.
Key Features:
Challenge:
A manufacturer needed a CER for a Class III knee implant to maintain CE marking under EU MDR.
Solution by Bioexcel:
Outcome:
Challenge:
An IVD manufacturer required an updated CER for their diagnostic kit to comply with MDR requirements.
Solution by Bioexcel:
Outcome:
Challenge:
A startup lacked clinical trial data for their wound care device and needed a literature-based CER to support CE marking.
Solution by Bioexcel:
Outcome:
Regulatory Expertise
In-depth knowledge of EU MDR, FDA, and CDSCO requirements.
Tailored Solutions
Customized CERs based on your device’s risk class and intended use.
End-to-End Support
From data collection to Notified Body submissions.
Proven Success
A track record of successful CER approvals for diverse devices.
All medical devices seeking CE marking under EU MDR, including Class I, IIa, IIb, and III devices, require a CER.
CERs must be updated regularly based on the device’s risk class, typically every 1–3 years, or when significant new data becomes available.
Yes, we specialize in literature-based CERs, particularly for devices with limited clinical trial data, by leveraging equivalent device comparisons and published evidence.
Ensure your medical device meets global safety and performance requirements with Bioexcel’s Clinical Evaluation Report (CER) services. Contact us today to streamline your regulatory submissions and maintain compliance.
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