Medical Device Registration in

Estonia

Ministry of Health

Sotsiaalministeerium / Ministry of Social Affairs

Regulatory Authority

Medical Devices Department, Estonian Health Board

Medical Device Regulation

EU MDR 2017/745

Official Language

Estonian

Classification

Class I, IIa, IIb and III

Registration Process

  • Obtain CE Marking certificate.
  • Appoint Authorized Representative.
  • Determine the class of the device.
  • 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.
  • Prepare a Declaration of Conformity.

Documents Required

  • CE certificate;
  • QMS certificate
  • Declaration of Conformity.
  • Notification consists of submission of at least the following information:

The name and address of the person responsible for placing a product on the Estonian market, responsible for distribution or put into service in Estonia;

The name and address of the manufacturer of medical devices and, if applicable the name and address of the authorised representative in the EU;

The name and intended purpose of the device in Estonian and English;

The identification of the device (commercial name of the device, model or catalogue number).

  • CE Technical File
  • Package Insert, Label or User Manual
  • Letter of Authorization

 

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

  • Class I : 4-6 weeks
  • Others : Based on Notified Body timeline

Authorized Representative

Yes

License Validity

5 years

Special Notes

IFUs or package Inserts should be in Estonian

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