Vastuskiri

Dear Juliane Wober,

Regarding other clinical investigations according to Art. 82 MDR Estonian Medical Devices Act states:

§ 22¹.  Requirements for the conduct of other clinical investigations of medical devices and applying for right to conduct such investigations

  In the event of investigations specified in Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council, the requirements provided for in subsections 2–7 of Article 62 and in Articles 63–66, 68–72, 75–77 and 80 are applied except for in those aspects concerning the submission of documents and exchange of information through the electronic system specified in Article 73 and the requirement to prepare a clinical assessment plan.
[RT I, 22.12.2022, 2 – entry into force 01.01.2023]

Medical Devices Act can be found in English here - https://www.riigiteataja.ee/en/eli/ee/515032023005/consolide/current

Additional requirements related to fees applicable to clinical investigation and performance study applications are given in relevant national regulation (available only in Estonian) - https://www.riigiteataja.ee/akt/113012023010

For more detailed information on topic of clinical investigations and performance studies please have a look at information given on Health Board web site as well - https://terviseamet.ee/en/clinical-investigations-and-performance-studies  

In case of any additional questions do not hesitate to contact us again.

Dear Sir or Madam,

I hope this email finds you well. Could you please forward this email to the person who it may concern?

I am a researcher at the Faculty of Medicine at the TUD Dresden University of Technology, Germany. I am currently working on a comparison of the different implementations of other clinical investigations according to Article 82 of Regulation (EU) 2017/745 (MDR) in the different EU member states. For this purpose, I am gathering information on the current national legislation pertaining to medical devices of each EU member state. I am writing to you to get answer to the following questions:

• How do you handle other clinical investigations according to Art. 82 MDR in your EU member state?

• Have you additional requirements defined for other clinical investigations according to Art. 82 MDR?

• Could you provide your current valid national legislation concerning medical devices and clinical investigations with medical devices? (It can be written in your national language.)

I hope to hear from you and thank you very much for your support.

Best regards

Juliane Wober

Juliane Wober, M.Sc.

Regulatory Affairs

Else Kröner Fresenius Center for Digital Health
Faculty of Medicine Carl Gustav Carus

TUD Dresden University of Technology

Phone:    +49 (0)351 458-18589

Mail: [email protected]

Web: digitalhealth.tu-dresden.de/