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/