Clinical Evaluation Plan (CEP)

What is a Clinical Evaluation Plan?

The Clinical Evaluation Plan (CEP) is a critical regulatory document that describes how you (the manufacturer) plan to identify, screen, assess and analyse relevant clinical data that supports the safety and performance of your medical device. The outcome of this identification, screening, assessment and analysis will be documented in the Clinical Evaluation Report (CER).

The CEP will follow the requirements as defined in the European Medical Device Regulation (MDR), Annex XIV, Part A, Section 1(a).

AML Christensen’s service

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

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

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Clinical Evaluation Plan (CEP)

What is a Clinical Evaluation Plan?

AML Christensen’s service

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