Vastuskiri

Dear Sir/Madam,

For national notification obligations, please see the Estonian Medical Devices Act, with § 16 and 26 (4) being probably the most relevant.

Notification can be completed via the Estonian Medical Device Database (EMDDB, https://msa.sm.ee/) and is free of charge.

The required documents for device notification include: Declaration of conformity, certificates (if applicable), instructions for use, and a copy of the labeling or packaging.

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password.

For creating an account we need a contact person’s full name, e-mail and the position in the company. If there is a need for an account, please let me know.

Additionally, please refer to the short guide available on the Estonian Medical Device Database homepage under "Forms" for step-by-step instructions on successful notification.

Best regards

Piret Põiklik 

Head of Department

Department of Medical Devices

Phone +372 5853 3610

[email protected] | [email protected]

This e-mail and any attachments may contain sensitive and privileged information. If you are not the intended recipient, please notify the sender immediately by return e-mail, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be illegal.

Dear Sir/Madam,

I am writing to inquire about the additional notification requirement for medical devices made available on the Estonian market. Specifically, I would like to know if a product manufactured by a legal entity based in the USA, with an authorized representative in the Netherlands, who has registered the products there for market access in accordance with the Medical Device Directive (MDD)/Medical Device Regulation (MDR), requires any additional notification.

Furthermore, the distributor and importer in the European Union are both located in Germany. If such notification is necessary, I kindly request detailed guidance on how to proceed with this remotely. Would it be required to obtain a login and password for the respective database, or should a national/local e-signature be established for this purpose? Additionally, could you please advise on the necessary documentation to include with the notification?

Your prompt response and guidance on this matter would be greatly appreciated.

Yours faithfully,

Aleksandra Skoczka

Regulatory Affairs Specialist EMEA

Align Technology,

Bierutowska 57-59, 51-317 Wroclaw, Poland

email [email protected]


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