Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001: Difference between revisions
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| | | [[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00057-Com-deR|Competent authority]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | EU ; GBR MDCG 2020-10/1
- Safety reporting in clinical investigations of medical devices 2020 |
| Validity area | EU ; GBR |
| Scope(s) | MD |
| Document name | MDCG 2020-10/1
- Safety reporting in clinical investigations of medical devices |
| Version / Revision | 2020 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | MDCG 2020-10/1 Rev 1
Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.3.5 |
| Scope | MD |
| Document part | 8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Reporting timeline, Urgent safety measure, Sponsor, Competent authority, Clinical investigation |
| Comment | Repeated entry: 5.3.5 ++ 5.3.6
Reporting timelines: sponsor to NCAs (device investigation) |
Content
8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • For all reportable events as described in section 5 which indicate an imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: 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. This includes events that are of significant and unexpected nature such that they become alarming as a potential public health hazard. It also includes the possibility of multiple deaths occurring at short intervals. These concerns may be identified by either the NCA or the manufacturer. • Any other reportable events as described in section 5 or a new finding/update to it: 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. In some cases, a different periodicity or different modalities may be agreed between the participating NCAs and the sponsor according to the investigation’s design and to the pathology under clinical investigation. This would allow implementation of adequate provision for clinical investigations in which SAE frequency is expected to be high due to the natural progression of the disease (e.g. palliative oncology).
