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Saatja: RA MSO </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=72F3C63240224E00B8EFA069E66B5C58-RA> Saaja: Vanessa-Alexandra Vasile Teema: Vs: Inquiry about national registration and reporting requirements for medical devices and in-vitro-diagnostics 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 <https://www.riigiteataja.ee/en/eli/ee/510012025003/consolide/current> . 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] <mailto:[email protected]> +372 5853 3610 1 Nooruse Street 50411 Tartu Estonia Phone: +372 737 4140 www.ravimiamet.ee <http://www.ravimiamet.ee/> This e-mail and any attachments transmitted may contain confidential and privileged information. If you are not the intended recipient, please notify the sender immediately by returning the e-mail and permanently deleting what you have recieved. Any dissemination or use of this information by a third person without permission is prohibited and may be illegal. Saatja: Vanessa-Alexandra Vasile <[email protected]> Saatmisaeg: neljapäev, 13. märts 2025 16:56 Adressaat: RA MSO <[email protected]> Teema: Inquiry about national registration and reporting requirements for medical devices and in-vitro-diagnostics Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. 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 Vanessa-Alexandra Vasile B.Sc. Beraterin Johner Institut GmbH [email protected] <mailto:[email protected]> Tel.: +49 (0) 7531 9450020 Reichenaustraße 39a D-78467 Konstanz HRB 710768 | Amtsgericht Freiburg Umsatzsteuer-ID: DE292335387 Geschäftsführer: Markus Gerhart <https://www.johner-institut.de/gratis-angebote/instituts-journal/>