Market surveillance

Market surveillance is what the authorities do, while post-market surveillance is what manufacturers do. It can include document checks, inspections, sampling and testing, and it can end in restrictions, withdrawals or recalls ordered by the authority.

‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

EU MDR, Article 2(61)

‘market surveillance’ means the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

IVDR, Article 2(64)