Ministry of Health

Cabinet of Ministers Republic of Latvia

Regulatory Authority

State Agency of Medicines , Republic of Latvia

Medical Device Regulation

Medical Treatment Law

Regulation No. 689 – Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices

EU MDR 2017/745

Official Language

Latvian

Classification

Class I, IIa, IIb and III

Medical Device Registration in Latvia

• 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 Latvia

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

Applicable QMS

ISO 13485

Registration Timeline

Class I: 4-6 weeks

Other: Based on Notified Body

Authorized Representative

Yes

License Validity

5 years

Special Notes

• IFUs and Labels should be in the Latvian language
• The notification of class I, and other IVD medical devices is not mandatory.
• There are no fees for notification and registering medical devices at the national medical devices database.