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,
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,
The PMCF study is mandatory:
If the device is CE marked and no clinical study has been conducted so far.
Constructional materials, substances, principles of operation, technology or the medical indications are novel.
