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

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