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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

Protocol Assistance (PA)

Protocol assistance is the special form of scientific advice available for companies developing designated orphan…

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I

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational…

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