View source for Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002

{{#set:
|HasDocument=Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021
|RefScope=MD
|RefDocPart=2.
|RefLanguage=EN
|RefTags=TAG-00203-Cli-lin ++ TAG-00046-Ser-sSc ++ TAG-00212-Inc-nis ++ TAG-00340-Req-nfo ++ TAG-00155-Med-Med
|RefModule=5
|RefUnit=5.3.6
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{{:Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021}}

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.3.6
|-
! Scope
| MD
|-
! Document part
| 2.
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00203-Cli-lin|Investigation plan]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00212-Inc-nis|Incident]], [[Glossary:TAG-00340-Req-nfo|Requirements]], [[Glossary:TAG-00155-Med-Med|Medical device]]
|-
! Comment
| Repeated entry: 5.2.4 ++ 5.3.6

CIP content: SAE recording and reporting procedures (repeated)
|}

== Content ==
2. Clinical Investigation Plan 
[….]
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).
[…]