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Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021
|has_document=Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021
|RefScope=MD
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|RefDocPart=2.
|unit=5.2.4
|RefLanguage=EN
|scope=MD
|RefTags=TAG-00203-Cli-lin ++ TAG-00046-Ser-sSc ++ TAG-00212-Inc-nis ++ TAG-00340-Req-nfo ++ TAG-00155-Med-Med
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|tags=TAG-00203-Cli-lin ++ TAG-00046-Ser-sSc ++ TAG-00212-Inc-nis ++ TAG-00340-Req-nfo ++ TAG-00155-Med-Med
{{:Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021}}
|tags_display=[[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
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.2.4
|-
! 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 data recording and reporting requirements
CIP content: SAE data recording and reporting requirements
|}
|content=2. Clinical Investigation Plan  
 
== 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).
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).
[…]
[…]
}}

Latest revision as of 13:50, 16 July 2026



Document information
Reference GBR Clinical investigations of medical devices –

compiling a submission to MHRA May 2021

Validity area GBR
Scope(s) MD
Document name Clinical investigations of medical devices –

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 – compiling a submission to MHRA

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 5 — 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

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). […]

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