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Glossary

CE Marking

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CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable Medical Device Directives (including for In Vitro Diagnostic Device IVD and Active Implantable Medical Device AIMD).

CE Marking shall be obtained by manufacturers prior to marketing, distribution and sale of their medical devices in any EU Member State.

Notified Body assessment is required for CE marking of moderate to high class medical devices. A regulation, binding in its entirety, is to replace the existing MD Directives in Europe.

Other glossary definitions

C

Core Value Dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA…

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E

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as…

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