Kiri

Dear Sir,

Greetings of the day!!

We are a Pharmacovigilance and Regulatory service provider company, and we need information regarding submission of Serious adverse event report during performance testing (clinical trial) of the IVDR to Estonia agency. Kindly provide following information:

For Single event during clinical trial:

• Timeline of reporting (local & Foreign)?

• Format of report (CIOMS or any local form/ format)? Please share the local ADR reporting form, if applicable.

• Mode of transmission of report. (By fax or email or mail or any online portal). Please let us know the email ID or contact detail for courier or Agency’s portal link, as applicable.

For Periodic safety reporting:

• Timeline of reporting (local & Foreign)?

• Format of report (any local form/ format)? Please share the local reporting format, if applicable.

• Mode of transmission of report. (By fax or email or mail or any online portal). Please let us know the email ID or contact detail for courier or Agency’s portal link, as applicable.

Also, please let us know if the reports are required to be submitted by a local representative. In case of no local representative can sponsor based out of Estonia submit the reports directly.

Your early response is much appreciated.

Note: If this email is not relevant to you, request you please direct this to the relevant team and guide us accordingly.

Thanks and Regards,

Manmeet Singh.

Regulatory Affairs Associate.

APCER
LIFE SCIENCES

Together for better health

Stay Safe, Healthy, and Strong.

Dear Manmeet Singh,

There is a MDCG 2020-10/1  guide document regarding safety reporting in clinical investigations published under European Commission guidance. It is considering MDR clinical trials, but, as we know, similar document regarding IVDR trials is in preparation at the moment. Hopefully it will we published soon. As long we suggest to take notes from this document, for example in regard of reporting timelines.

Guidance on safety reporting in clinical investigations - https://health.ec.europa.eu/system/files/2022-11/md_mdcg_2020-10-1_guidance_safety_reporting_en.pdf

Appendix: Clinical investigation summary safety report form - https://health.ec.europa.eu/document/download/bf136f27-27da-4a31-97c2-a5de741c3493_en?filename=md_mdcg_2020-10-2_guidance_safety_report_form_en.xlsx

All MDCG endorsed documents and other guidance can be found here (topics selection at left) - https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec3

Below I´ll try to give answers to you questions one by one as well:

For Single event during clinical trial:

• Timeline of reporting (local & Foreign)? – accordingly to MDCG 2020-10/1 document immediately, but not later than 2 calendar days after awareness by sponsor of a new reportable event or of new information in relation with an already reported event and immediately, but not later than 7 calendar days following the date of awareness by the sponsor of the new reportable event or of new information in relation with an already reported event.

• Format of report (CIOMS or any local form/ format)? Please share the local ADR reporting form, if applicable. No local format, MDCG reporting form should be used until Eudamed module is available.

• Mode of transmission of report. (By fax or email or mail or any online portal). Please let us know the email ID or contact detail for courier or Agency’s portal link, as applicable. All the information can be submitted via e-mail [email protected]

For Periodic safety reporting:

• Timeline of reporting (local & Foreign)? Same as prevoius.

• Format of report (any local form/ format)? Please share the local reporting format, if applicable. Same as prevoius.

• Mode of transmission of report. (By fax or email or mail or any online portal). Please let us know the email ID or contact detail for courier or Agency’s portal link, as applicable. Same as prevoius.

Also, please let us know if the reports are required to be submitted by a local representative. In case of no local representative can sponsor based out of Estonia submit the reports directly. Yes, sponsor can contact us directly. There is no obligation for local representative, but please note that accordingly to IVDR Article 58(4), if sponsor is located outside the Union, legal representative shall be established.

Hope this information will be useful. In case of aby additional questions or doubts do not hesitate to contact us again

Dear Sir,

Greetings of the day!!

We are a Pharmacovigilance and Regulatory service provider company, and we need information regarding submission of Serious adverse event report during performance testing (clinical trial) of the IVDR to Estonia agency. Kindly provide following information:

For Single event during clinical trial:

• Timeline of reporting (local & Foreign)?

• Format of report (CIOMS or any local form/ format)? Please share the local ADR reporting form, if applicable.

• Mode of transmission of report. (By fax or email or mail or any online portal). Please let us know the email ID or contact detail for courier or Agency’s portal link, as applicable.

For Periodic safety reporting:

• Timeline of reporting (local & Foreign)?

• Format of report (any local form/ format)? Please share the local reporting format, if applicable.

• Mode of transmission of report. (By fax or email or mail or any online portal). Please let us know the email ID or contact detail for courier or Agency’s portal link, as applicable.

Also, please let us know if the reports are required to be submitted by a local representative. In case of no local representative can sponsor based out of Estonia submit the reports directly.

Your early response is much appreciated.

Note: If this email is not relevant to you, request you please direct this to the relevant team and guide us accordingly.

Thanks and Regards,

Manmeet Singh.

Regulatory Affairs Associate.

APCER
LIFE SCIENCES

Together for better health

Stay Safe, Healthy, and Strong.