Küsimused

Dear Vanessa-Alexandra Vasile,

Thank you for contacting us.

For national requirements for medical devices please see the national Medical Devices Act, available here in English. Make sure to have the „In force“ version open.

For registration and language requirements the most relevant points are § 26 and 16 but others might be of intererst as well.

We have some information in English in our webpage as well:

https://ravimiamet.ee/en/medical-devices/regulation-field-medical-devices-estonia - under this link there is information on fees currently in effect and a link to our national database

https://ravimiamet.ee/en/medical-devices/labelling-language-requirements - under this link you can find a paper that has been recently published to further explain the language requirments

I hope this is of use, please let us know if you have further questions.

Best regards,

Piret Põiklik
Head of Department

Department of Medical Devices
State Agency of Medicines

[email protected]
+372 5853 3610

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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Dear Sir or Madam,

Johner Medical GmbH is an EU Authorized Representative in accordance with Articles 11 and 12 of the Medical Device Regulation (MDR) (2017/745) and the In Vitro Diagnostic Regulation (IVDR) (2017/746), based in Germany.

As an EU Authorized Representative, we strive to provide comprehensive regulatory support to our customers. We regularly receive inquiries regarding the additional registration of medical devices in the individual EU Member States while the European database is not yet fully operational.

In order to be able to offer our customers precise and legally compliant support, we would be very grateful for your feedback on the specific national requirements for the registration and reporting of medical devices and in-vitro-diagnostics in your country.

We are particularly interested in the following points:

- Registration and reporting obligations: Are there national regulations that go beyond European requirements? If so, what additional registration and reporting obligations exist for manufacturers, importers, and distributors?

- Language requirements: In which language must documents be submitted?

- Role-specific requirements: Are there country-specific regulations for different economic operators (e.g., manufacturers, importers, distributors, authorized representatives)? 

We would also like to understand which registration obligations importers must fulfil and how these can be complied with in the case of direct imports.

- Additional national requirements: Are national databases, fees, or mandatory certifications required?

We would appreciate any references to official guidelines, national laws, or regulatory documents.

Please also let us know your preferred contact points for further communication. 

Thank you in advance for your support!

With best regards,

Vanessa-Alexandra Vasile