Medical Device Registration in
Lithuania
Ministry of Health
Ministry of Health of the Republic of Lithuania
Regulatory Authority
State Service of Accreditation for Healthcare Activities
Medical Device Regulation
EU MDR 2017/745
Official Language
Lithuanian
Classification
Class I, IIa, IIb and III
Registration Process
- Determine the device classification
- Appoint Authorized Representative and Notified Body
- Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
- For other classes, prepare a CE Technical File
- Obtain and register UDI in EUDAMED.
- Technical File should be audited by Notified Body.
- Once approved, prepare a Declaration of Conformity.
- The device can now be marketed in Lithuania
Documents Required
- CE Certificate
- Declaration of Conformity
- Technical File
- QMS Certificate
- Risk Management Plan
- IFUs, Label or User Manual
- Clinical Studies Report
- Postmarket Surveillance Plan
Post-market Requirements
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Applicable QMS
ISO 13485
Registration Timeline
Registration : 15-30 days
Notification: 10 days
Authorized Representative
Yes
License Validity
Does not expire