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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

P

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming…

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S

Summary of product characteristics (SmPC)

Part of the marketing authorization of a medicinal product setting out the agreed position of…

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