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Glossary

Clinical Evaluation Report (CER)

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Required under the new MEDDEV 2.7.1 Rev. 3 guidelines.

Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.

Other glossary definitions

A

Abnormal Use

Act or omission of an act by the operator or user of a medical device…

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E

Environmental Risk Assessment (ERA)

In accordance with Article 8(3) of Directive 2001/83/EC, as amended, the evaluation of the potential…

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