Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/4777-4 |
| Registreeritud | 06.05.2024 |
| Sünkroonitud | 07.05.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | 11.2-1/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Syneos Health |
| Saabumis/saatmisviis | Syneos Health |
| Vastutaja | Sofia Ratušnaja (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Mon, 06 May 2024 13:57:46 +0000
To: "Sabatini Martin; Ana Rosa" <[email protected]>
Subject: Vs: URGENT_Estonia_Question on safety reporting in clinical studies with Medical Devices & IVDs
Dear Ana Rosa,
As there are no special provisions on the matter of site reporting in Estonian legislation or some national guidance, yes, we can confirm that we support the approach that site reporting should be defined by sponsor in CIP or PSP, and followed.
Best regards,
Sofia Ratušnaja
Chief Specialist
Medical Devices Department
+372 5661 5491
[email protected] | [email protected]
Republic of Estonia
Health Board
+372 794 3500
Paldiski mnt 81, 10614 Tallinn
Estonia
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or
copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by
mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Sabatini Martin, Ana Rosa <[email protected]>
Saatmisaeg: esmaspäev, 6. mai 2024 13:12
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Koopia: SPVG Regulatory Intelligence <[email protected]>
Teema: URGENT_Estonia_Question on safety reporting in clinical studies with Medical Devices & IVDs
Tähtsus: Kõrge
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sr/Madam:
Thank you so much for your feedback.
Just for clarification, the guidance MDCG 2020-10/1 basically defines the process for Collecting reports from investigators (section 4.3):
Related to my previous question , we have received feedback from several Regulatory Authorities that site reporting should follow the Clinical Investigation Plan / Performance Study Plan as it is not defined in the EU MDR / IVDR.
Could you please confirm that site reporting in Estonia should also follow the Clinical Investigation Plan / Performance Study Plan?
Thank you so much.
Best regards,
Ana Rosa
Ana Rosa Sabatini Martín
Sr QPPV Office Specialist
Drug Safety & Pharmacovigilance
Spain – Home Based
Phone +34 914 23 07 50
Email: [email protected]
From: Meditsiiniseadmed (Medical Devices) <[email protected]>
Sent: Friday, May 3, 2024 12:02
To: Sabatini Martin, Ana Rosa <[email protected]>
Subject: [EXTERNAL] Vs: Estonia_Question on safety reporting in clinical studies with Medical Devices & IVDs
Dear Ana Rosa, Both Regulations MDR and IVDR and according Guidance MDCG 2020-10/1 on MDR and newly published MDCG 2024-4 on IVDR Safety Reporting only oblige Sponsor to report to NCA-s, where the clinical investigation has commenced. Additionally,
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Dear Ana Rosa,
Both Regulations MDR and IVDR and according Guidance MDCG 2020-10/1 on MDR and newly published MDCG 2024-4 on IVDR Safety Reporting only oblige Sponsor to report to NCA-s, where the clinical investigation has commenced.
Additionally, guidelines underline, that sponsor must implement a system for reporting to investigators, in free format.
As there is no provisions on reporting back to investigator by sponsor in given documents, it can be concluded that it is up to sponsor to set up the system on this matter.
Best regards,
Sofia Ratušnaja
Chief Specialist
Medical Devices Department
+372 5661 5491
[email protected] | [email protected]
Republic of Estonia
Health Board
+372 794 3500
Paldiski mnt 81, 10614 Tallinn
Estonia
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or
copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by
mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Sabatini Martin, Ana Rosa <[email protected]>
Saatmisaeg: teisipäev, 30. aprill 2024 16:06
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Koopia: SPVG Regulatory Intelligence <[email protected]>
Teema: Estonia_Question on safety reporting in clinical studies with Medical Devices & IVDs
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sr/Madam:
Syneos Health (Clinical Research Organization) is responsible for the safety reporting on behalf of Sponsors in the frame of Clinical Investigations with Medical Devices and Performance Studies with In Vitro Diagnostics (IVDs);
We would much appreciate if you could please provide with your feedback to my question below:
- The EU MDR & IVDR do not specify Sponsor safety reporting obligations to investigational sites. Therefore, it is assumed that the Sponsor does not need to submit safety reports to investigational sites unless specified by the Clinical Investigational Plan/Performance Study Plan.
Could you please confirm your alignment with the above statement?
Thank you so much for all your support.
Best regards,
Ana Rosa
Ana Rosa Sabatini Martín
Sr QPPV Office Specialist
Drug Safety & Pharmacovigilance
Spain – Home Based
Phone +34 914 23 07 50
Email: [email protected]
EMAIL DISCLAIMER NOTICE:
Syneos Health, (the “Company”). This email and any files transmitted may contain information that is privileged, confidential and exempt from disclosure and is intended solely for the intended recipient. If you received this email in error, please inform the sender and delete it. This email neither constitutes an agreement to conduct transactions by electronic means nor creates any legally binding contract or enforceable obligation in the absence of a fully signed written contract. Any views or opinions expressed are solely those of the author and do not necessarily represent those of the Company. Although the Company has taken reasonable precautions to ensure no viruses are present in this email, the Company cannot accept responsibility for any loss or damage arising from the use of this email or attachments.
EMAIL DISCLAIMER NOTICE:
Syneos Health, (the “Company”). This email and any files transmitted may contain information that is privileged, confidential and exempt from disclosure and is intended solely for the intended recipient. If you received this email in error, please inform the sender and delete it. This email neither constitutes an agreement to conduct transactions by electronic means nor creates any legally binding contract or enforceable obligation in the absence of a fully signed written contract. Any views or opinions expressed are solely those of the author and do not necessarily represent those of the Company. Although the Company has taken reasonable precautions to ensure no viruses are present in this email, the Company cannot accept responsibility for any loss or damage arising from the use of this email or attachments.
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 06.05.2024 | 1 | 11.2-1/24/4777-3 | Sissetulev dokument | ta | Syneos Health |
| Kiri | 03.05.2024 | 3 | 11.2-1/24/4777-1 | Sissetulev dokument | ta | Syneos Health |
| Vastuskiri | 03.05.2024 | 3 | 11.2-1/24/4777-2 | Väljaminev dokument | ta | Syneos Health |