Medical devices (due to EU regulations)
From 1st of May, 2004, only those medical devices, which comply with the requirements of EC Medical Device Directives, can be placed on the Lithuanian market and put into service. All medical devices must fulfil the essential requirements of the medical device legislation. All medical devices must bear the CE marking. The only exceptions are: custom-made medical devices, devices intended for clinical investigation as well as in vitro diagnostic medical devices intended for performance evaluation.
At the point when the device reaches the final user, irrespective of the users competence (professional or not), all information supplied by the manufacturer (label, instructions for use) must be in Lithuanian language.
There are three types of medical devices:
EC directives covering medical devices:
The provisions of the above EC Directives are transposed to the national law by the technical regulations:
Accreditation agency performs the market surveillance activities. The main object of this activity is to ensure that the medical devices are placed on Lithuanian market under the requirements of Medical device directives. Here you can find the National market surveillance programme.
Other useful information concerning the medical devices legislation can be found on the European Commission’s website.
Page changed 2014-06-11
State Health Care Accreditation Agency
under the Ministry of Health
Jeruzalės str. 21,