Glossary

Post-market surveillance [MDR/IVDR]

MDR IVDR

‘Post-market surveillance’ means 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.

 

[Definition under (EU) 2017/745 Article 2 No. 60 also corresponds to definition under (EU) 2017/746 Article 2 No. 63]