Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA>
Saaja:
[email protected],
[email protected]
Teema: Vs: Estonia Medical Devices_ Regulatory updates
Dear Sujana Kovvuri,
Any regulatory updates can be found at any given moment in Riigi Teataja and specifically when looking at the Estonian Medical Devices Act <https://www.riigiteataja.ee/en/eli/ee/503102025002/consolide/current> , you are able to select the version In force as well as move to any previous versions.
To switch to the version in English please choose the tab marked with green:
You can find the latest update time also with the text (marked yellow):
If anyone wants to see what has changed in the regulation, they should choose option „Compare wordings“ and that allows to choose any two versions of the act for side to side comparison. Changes in text will appear in red and green after you have clicked „Compare“.
I will add that the last change in the act did not include changes to safety reporting.
Best regards,
Piret Põiklik
Head of Department
Department of Medical Devices
State Agency of Medicines
[email protected] <mailto:
[email protected]>
+372 5853 3610
1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
www.ravimiamet.ee <http://www.ravimiamet.ee/>
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From: Kovvuri, Sujana <
[email protected] <mailto:
[email protected]> >
Sent: Thursday, November 20, 2025 7:23 PM
To: Ravimiamet <
[email protected] <mailto:
[email protected]> >
Cc: Madhusudhan, Renuka <
[email protected] <mailto:
[email protected]> >
Subject: Estonia Medical Devices_ Regulatory updates
Dear Team,
Hope you are doing well.
As a part of Bi-Annual review, can you please provide us any regulatory updates for Medical devices in Estonia.
We update Safety Reporting Requirements tracker of Medical devices as per the changes required.
Kind regards,
Sujana Kovvuri
Asst II Pss
Patient Safety Solutions
E:
[email protected] <mailto:
[email protected]>
Fortrea Development Ltd
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