Clinical Evaluation Report (CER)

What is a Clinical Evaluation Report?

The Clinical Evaluation Report (CER) is a regulatory document that summarizes the evaluation of all relevant clinical data for your device. The CER is required for all medical devices that are sold or distributed within the European Union. The clinical data in the CER may be identified from several sources such as your own clinical investigations, your post-market surveillance (PMS), post market clinical follow-up (PMCF) activities, external literature databases and device registries as well as regulatory and vigilance databases. The exact sources that will be used for your device, will be thoroughly described in the Clinical Evaluation Plan.

The CER is compiled according to the requirements of the MDR Annex XIV, Part A.

AML Christensen’s service

At AML Christensen, we have a long-lasting experience in developing CERs that comply with the requirements of the EU MDR and relevant guidelines. Depending on the classification of your device, the CER will need to be updated every 1-5 years. At AML Christensen, we can create the first CER for your device and ensure that the CER is regularly updated throughout the device’s lifetime.

At AML Christensen, we have a proven CER template, which has been developed to ensure that the requirements of the MDR are met. Your CER may be built using the AML template or we can use your own template, if you prefer.

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Clinical Evaluation Report (CER)

What is a Clinical Evaluation Report?

AML Christensen’s service

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