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Glossary

Post-market surveillance

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All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions. 

Other glossary definitions

P

Post-Authorization Efficacy Study (PAES)

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

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E

EudraCT Form

A harmonized application form is used for clinical trial applications across the European Union. EudraCT…

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