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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

I

Important Missing Information

Critical gaps in knowledge for specific safety issues or populations that use the marketed product.

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M

Market Exclusivity

The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for…

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