Medical Device Registration in
Ministry of Health
State Agency of Medicines , Republic of Latvia
Medical Device Regulation
Regulation No. 689 – Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices
EU MDR 2017/745
Class I, IIa, IIb and III
- 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
- CE Certificate
- Declaration of Conformity
- Technical File
- QMS Certificate
- Risk Management Plan
- IFUs, Label or User Manual
- Clinical Studies Report
- Postmarket Surveillance Plan
Class I: 4-6 weeks
Other: Based on Notified Body
- 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.