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Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation

The Objective of Clinical Evaluation

Clinical Evaluation Data

Clinical Evaluation Plan (CEP)

Class III Devices and Implantable Devices

Annex XIV

Equivalence

Clinical

Technical

Biological

FAQs

What do you mean by clinical evaluation?

A clinical evaluation is a systematic and well-planned procedure used to acquire, gather, analyse, and ultimately evaluate clinical data for a medical device.

What is clinical evidence?

Clinical evidence is defined as clinical data and clinical evaluation results about a device of sufficient amount and quality to permit a qualified assessment of whether the device is secure and provides the expected clinical benefit(s) when used in accordance with the manufacturer’s instructions.

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