Reference:GBR Clinical investigations of medical devices β compiling a submission to MHRA May 2021 2.-001
From GxPlex
| Document information | |
|---|---|
| Reference | GBR Clinical investigations of medical devices β
compiling a submission to MHRA May 2021 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | Clinical investigations of medical devices β
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 β compiling a submission to MHRA |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 β Unit 5.2.4 |
| Scope | MD |
| Document part | 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigation plan, Serious adverse event, Incident, Requirements, Medical device |
| Comment | Repeated entry: 5.2.4 ++ 5.3.6
CIP content: SAE data recording and reporting requirements |
Content
2. Clinical Investigation Plan [β¦.] 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). [β¦]
