Küsimused

Dear Ms./Mrs.,

I hope this email finds you well. I am reaching out to seek clarification on the reporting obligations for Medical devices in clinical trial

Estonia follows EU Regulation 2017/745, along with the guidelines set forth by the Medical Devices Coordination Group (MDCG), specifically MDCG 2020-10/1 rev.1 on safety reporting in clinical investigations and its Appendix: Clinical Investigation Summary Safety Report Form. Additionally, the national Medical Devices Act applies

From our understanding adverse incidents are submitted through the Estonian Medical Devices Appliances Database (EMDDB).  In the EMDDB website, the information about reporting adverse incidents is limited. I would like to ask for your support  in clarifying the following:

1. 1. Could you please confirm that the MDCG 2020-10/1 rev 1 Appendix: SAE report form is to be submitted through EMDDB?

2. 2. Are there any specific requirements for the SAE report form, such as preferred language or whether a signature is needed?

3. 3. ‘’Forms’’ section of EMDDB  provides a user guide for the database. Is there a similar guide available that explains the process of reporting adverse incidents through the system?

4. 4. If technical issues arise, is there an alternative method for submitting adverse incident reports?

We would greatly appreciate your guidance on these matters. Please let us know if any further details are required.

Looking forward to your response.

Best regards,

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