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