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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

E

EUDAMED

The European database for medical devices EUDAMED is to centralize:  Data relating to registration of…

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F

Food and Drug Administration (FDA or USFDA)

The FDA is a Federal agency within US Department of Health and Human Services, which…

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