Medical Device Registration in
Ministry of Health
Medical Device Regulation
EU MDR 2017/745
Class I, IIa, IIb and III
Medical Device Registration in Estonia
- 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.
- 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
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
- Class I : 4-6 weeks
- Others : Based on Notified Body timeline
IFUs or package Inserts should be in Estonian