Medical devices by the EU regulations


Medical devices may be placed on the Lithuanian market or put into service only if they comply with EU legislation regarding medical devices. 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.

Types of medical devices

  • General medical devices
  • In vitro diagnostic medical devices

EU legislation covering medical devices:

The provisions of EC Directive 98/79/EC are transposed to the national law by

Accreditation agency performs market surveillance activities. The main object of this activity is to ensure that medical devices are placed on Lithuanian market according to the requirements of EU legislation regarding medical devices.


Other useful information concerning the medical devices legislation can be found on the European Commission’s website.


Page changed 2022-01-14


State Health Care Accreditation Agency

under the Ministry of Health

A. Juozapavičiaus g. 9,
LT-09311 Vilnius
Tel. (+370) 5 261 51 77,
Fax. (+370) 5 212 73 10,

Budgetary institution,
Date is compiled and saved on the Register of Legal Entities,
Code 191352247

Work time:

I - IV 8:00 - 17:00
V 8:00 - 15:45
Lunch 12:00 - 12:45

Konsultacijos telefonu


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