Kiri

Dear Aleksa,

Thank you for your inquiry.

There is a notification requirement in Estonia based on Estonian Medical Devices Act § 26 (3-5) (https://www.riigiteataja.ee/en/eli/ee/524012023001/consolide/current) which says:

The distribution notification can be done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

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. 

Please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“.

Language requirements for medical devices in Estonia can be found also in Medical Devices Act § 16 (3) and it is written as following:

The manufacturer, relying on risk analysis, ascertains the information necessary for the safe use of a device for the intended purpose, and the information related with a medical device placed on the market, made available on the market, distributed and put into service in Estonia must be presented:

1) in the Estonian language and in an appropriate manner if the medical device is intended for the use of lay users;

2) in the Estonian or English language and in an appropriate manner if the medical device is intended only for the use of professional users;

3) in the language understandable to a specific user and in an appropriate manner in case of a custom-made medical device.

Please familiarize yourself comprehensively with the national Medical Devices Act so that you are up to date with the national requirements.

Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear Sir or Madam,

We have some questions regarding country-specific requirements for issuing a Class 1 medical device as a custom-made product (orthopedic insole).

The custom-made medical device is manufactured in Germany. All requirements of the MDR are already fulfilled.

Could you please inform us if there are any country-specific requirements? Does the product need to be registered? If yes, with which authority?

Please let us know if there are any additional requirements that we have not mentioned.

Thank you.

Mit freundlichen Grüßen – with kind regards

Aleksa Gašić