Clinical Evaluation Report (CER) Consulting for Medical Device Companies
Expert guidance to help your medical device meet EU MDR requirements with compliant a Clinical Evaluation Report (CER) and Clinical Evaluation Plan (CEP).
Importance of CER for CE Marking Compliance
Clinical Evaluation Reports (CERs) aren’t new to medical device compliance in Europe. However, with their inclusion in the MDR, clinical evaluation planning and reporting are officially a legal obligation for obtaining CE Marking. Not only must you submit a CER as part of your regulatory submission, but you must also continuously evaluate the clinical performance of your device throughout its life cycle and document your findings in your CER. Failure to maintain a compliant CER throughout the device lifecycle could jeopardize the marketability of your device, yet many manufacturers struggle to create a sustainable approach to ongoing clinical evaluation.
What is a clinical evaluation and when is it required?
The MDR defines clinical data as “the safety and/or performance information that is generated from the use of a device.” While this definition implies a need for clinical investigations, clinical data can be collected from a range of sources, such as historical data, scientific literature, clinical trials or a combination of these sources. CERs are required for all devices, though the scope of the clinical evaluation can vary depending on your device’s classification.
How to write a CEP and CER
Writing a Clinical Evaluation Plan and Clinical Evaluation Report to MDR specifications requires a deep understanding of the regulation, as well as the methods and sources used in clinical evaluation. MedEnvoy’s experts bring years of experience performing and writing clinical evaluation reports for a range of device types and risk profiles. We can help you prepare and maintain a compliant CER with scalable support options to fit your needs.
Turnkey CER preparation with consulting support
With our turnkey approach, we will deliver a compliant Clinical Evaluation Report ready for submission. Our report will be based on our assessment of your device’s existing clinical data, clinical experience, PMS data, incident and FSCA reports, and more, as well as our critical evaluation of the relevant scientific literature.
Comprehensive guidance throughout the device lifecycle
In addition to the CER, we will draft procedures to guide you through the clinical evaluation process throughout the lifecycle of your device, such as how to perform Clinical Evaluations, updating your Clinical Evaluation Report, and including Post Market Clinical Follow-Up data.
EU MDR CEP and CER templates for medical devices
For manufacturers with experienced in-house regulatory personnel who want a running start, our MDR CEP and CER templates can expedite and simplify your CER preparation. Our CER templates include an introductory session with our team so you feel confident customizing each template and applying the methodologies we use to compile a CER.
