Market surveillance for IVD-devices

According to the Decree No. 8/2003 (III.13.)EszCsM (hereinafter referred to as IVD-Decree) the Hungarian Competent Department will carry out market surveillance in four different ways:

- ad hoc supervision of manufacturers and authorised representatives
- if the IVD-device is not supplied by a health care provider, or used outside the public health care system, the Department shall notify the General Inspectorate for Consumer Protection due to Article 12 of the IVD-decree and of the Decree No. 33/2004 (III.8.)Korm. on „Safety of products and services”
- the supervision of the health care providers is carried out by the competent regional Institute of Public Health and Medical Officer Service. The supervision is based on a check list completed by the Competent Department.
- the Department carries out supervision on the base of quality complaints and in case of reported non-compliance

During the supervision of a CE-marked IVD-device the manufacturer or the authorised representative should supply:

- depending from the device’s classification a declaration of conformity, and where applicable the certificate of a Notified Body
- the registration documents
- in case of devices for performance evaluation a statement due to Annex 8 of the IVD-device and the registration documents
- the complete technical file of the device

The Notified Body shall submit all information and documents needed for conformity assessment to the Department upon request.

In case a supervision comes to the conclusion that the concerned device won’t fulfil conformity requirements, the resolutions of suspension or withdrawal are published in the Official Journal of the Ministry of Health.

The withdrawn resolutions can be seen in the web site.