Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| Regulatory Authority | Lithuanian State Health Care Accreditation Agency |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | EUMDR-2017/745 | Click Here |
| IVD Classification | A,B,C,D |
| In Vitro Diagnostics Regulations | (EU) 2017/746 | Click Here |
| Device Classification Guidelines | MDCG 2021-24 Guidance on classification of medical devices | Click Here |
| Registration Process | Registration (Manufacturing) Of Medical Devices Supplied To The Lithuanian Market | Click Here |
| Registration Timeline | For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Conformity Assessment Route |
EU declaration of conformity in accordance with Article 19 and Annex IV for the device model covered by the conformity assessment procedure.
The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of manufacturers in view of the low level of vulnerability associated with such devices. For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
| Click Here
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| Technical Documentation Format |
1. Device Description And Specification, Including Variants And Accessories 2. Information To Be Supplied By The Manufacturer 3. Design And Manufacturing Information 4. General Safety And Performance Requirements 5. Benefit-Risk Analysis And Risk Management 6. Product Verification And Validation | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in Lithuanian Language |
| Software Guidance Document |
MDCG 2023-4: Medical Device Software | Click Here |
| Additional Information | There is no fee for the submission of data on Class II a, II b, III medical devices , as well as active implantable medical devices manufactured to order, provided to the Lithuanian market. |