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