The goal of market surveillance is to ensure that the medical devices in use comply with the requirements and do not pose a threat to human health.
In the field of medical devices, the principle of free movement of goods applies. This means that a medical device legally placed on the market in one member state can be freely sold and used in other member states, and member states cannot prohibit or restrict the availability of compliant medical devices without a valid reason.
More information about the principles of the EU single market can be found from the Blue Guide.
One of the principles is the manufacturer's sole responsibility, which means that the manufacturer is solely responsible for ensuring that their product complies with all applicable requirements and that the appropriate conformity assessment procedures have been successfully completed. For higher-risk devices, the conformity assessment process must involve a notified body, which participates in the device's conformity assessment and issues the appropriate certificate.
These principles mean that medical devices do not undergo pre-market national control, and therefore, the State Agency of Medicines focuses on the surveillance and control of devices already on the market and the companies operating within it.
Main activities related to market surveillance:
- Advising users and companies, as well as checking reports of suspicious medical devices.
- Information exchange with other government agencies (Tax and Customs Board, Consumer Protection and Technical Regulatory Authority) and other member states.
- Non-compliances identified during inspections and routine checks.
- Surveillance of online sales platforms and advertising.
- Disseminating information related to medical devices (safety notices, information days, letters, etc.) to users, companies, and other interested parties.
- Authorization and surveillance of clinical investigations and performance studies.
Despite the fact that the manufacturer is responsible for the quality of the medical device from production to the end of its lifecycle, legislation also places obligations on other parties involved with medical devices. Every company involved in the distribution chain (EU authorized representative, importer, distributor) has the responsibility to ensure the device complies with the requirements before making it available. There is also a duty of care to ensure compliance when the device is put into use, including when providing services.
Last updated: 03.02.2025
