Reference:GBR Clinical investigations of medical devices â compiling a submission to MHRA May 2021 2.-001: Difference between revisions
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{{:Document:GBR Clinical investigations of medical devices â compiling a submission to MHRA May 2021}} | {{:Document:GBR Clinical investigations of medical devices â compiling a submission to MHRA May 2021}} | ||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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! Scope | |||
| MD | | MD | ||
|- | |- | ||
! | ! Document part | ||
| 2. | | 2. | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (EN) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (original language) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (FR) | ||
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! | ! Comment | ||
| Repeated entry: 5.2.4 ++ 5.3.6 | | Repeated entry: 5.2.4 ++ 5.3.6 | ||
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== | == Content == | ||
2. Clinical Investigation Plan  | 2. Clinical Investigation Plan  | ||
[âŚ.] | [âŚ.] | ||
Description of procedures and details of data to record and report serious adverse events and adverse device related incidents (in line with requirements in MEDDEV 2.7/3 or MDCG 2020-10/1). | Description of procedures and details of data to record and report serious adverse events and adverse device related incidents (in line with requirements in MEDDEV 2.7/3 or MDCG 2020-10/1). | ||
[âŚ] | [âŚ] | ||
Revision as of 14:27, 29 June 2026
| Document information | |
|---|---|
| Reference | GBR Clinical investigations of medical devices â
compiling a submission to MHRA May 2021 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | Clinical investigations of medical devices â
compiling a submission to MHRA |
| Version / Revision | May 2021 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | Guidance on legislation
Clinical investigations of medical devices â compiling a submission to MHRA |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | MD |
| Document part | 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Repeated entry: 5.2.4 ++ 5.3.6
CIP content: SAE data recording and reporting requirements |
Content
2. Clinical Investigation Plan [âŚ.] Description of procedures and details of data to record and report serious adverse events and adverse device related incidents (in line with requirements in MEDDEV 2.7/3 or MDCG 2020-10/1). [âŚ]
