REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Lithuania, devices are regulated by the Lithuanian State Health Care Accreditation Agency (VASPVT).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
Manufacturers of class IIa, IIb and III medical devices and custom made active implantable medical devices have to notify the Accreditation Agency when these devices are placed on the market in Lithuania. Alternatively, their authorized representatives or their authorized distributors have to notify the Accreditation Agency.
Lithuanian manufacturers or authorized representatives who have registered place of business in Lithuania must notify Accreditation Agency about the first placing on the market of:
- Class 1 medical devices
- Custom-made medical devices
- Procedure packs and systems (Article 12 of the Directive 93/42/EEC)
- In-vitro diagnostic medical devices
- Custom made active implantable medical devices
In addition – Manufacturers of medical devices of IIA, IIB and III class and custom made active implantable medical devices or their authorized representatives, or their authorized distributors have to notify Accreditation Agency when these devices are placed on the market in Lithuania.