Market Surveillance

The Hungarian Competent Department has four different ways to carry out market surveillance:

- the Department carries out ad hoc manufacturer and distributor supervision;

- if the device is not supplied by a health care provider, or used outside the health care system, the Department shall notify the General Inspectorate for Consumer Protection to take the appropriate measures;

- the supervision of the health care providers is carried out by the competent regional institute of the National Public Health and Medical Officer Service. The supervision is based on a check list drawn up by the Competent Authority;

- the Department carries out supervision on the bases of quality complaint and in case of cases reporting non-compiance.

During the supervision of a CE-marked medical device the manufacturer shall supply:
- the conformity assessment document;
- declaration of conformity;
- registration document;
- technical file;
depending on the classification and the origin of the device.

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

At the end of the inspection if a device does not fulfil the requirements the suspensional or withdrawal resolutions are published in the official journal of the Ministry of Health.

The withdrawn resolutions can be seen in the web site.

• Medical devices
• IVD
• Custom made devices