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This wiki is a structured reference database for regulatory documents in the medical devices, in vitro diagnostics, and pharmaceutical sectors. Each document is stored with standardized metadata (scope, validity status, region, official source) and linked to individual reference pages for key articles, annexes, and provisions.
== Welcome to GxPlex ==


The database currently covers regulations, directives, and guidelines in the MD, IVD, HM, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly.
Your shared map through the maze of clinical research regulations.


Structured queries are available on the [[Document_Index|Document Index]]. Use [[GxPlex_Search|GxPlex Search]] for filter-based browsing, or [[Special:Ask|Special:Ask]] for custom SMW queries.


All registered users can contribute. New pages require reviewer approval before becoming publicly visible.
Whether you're a Study Coordinator double-checking an SAE reporting timeline for a Medical Device trial, a CRA preparing for an audit, or a small sponsor wondering what applies to your trial in a new country, GxPlex is built to help you find your way.


== Quick navigation ==
=== What you'll find here ===
GxPlex is a collaborative, wiki-style database of laws, regulations, and guidelines relevant to clinical research — covering international treaties (ICH, ISO, WHO...), EU regulations, and national requirements across Germany, Austria, France, the UK, and the US, with more to come.


{| style="width:100%; border-collapse:collapse;"
Every reference is tagged so you can search and compare by country, research scope (IMP, Medical Devices, IVD...), document type, topic, and more.
|-
| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== Browse ===
* [[Document_Index|Document index]]
* [[GxPlex_Search|Search & filter]]
* [[Special:Ask|Custom SMW query]]
* [[Special:RecentChanges|Recent changes]]


| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== Getting started ===
=== By category ===
# New here?
* [[:Category:Medical Devices|Medical Devices]]
#* Head to [[About_GxPlex|About GxPlex]] to understand how it's organized.
* [[:Category:In Vitro Diagnostics|In Vitro Diagnostics]]
# Curious about the story behind it?
* [[:Category:Clinical|Clinical]]
#* Visit [[The_Project|The Project]] to meet the people who started it.
* [[:Category:Post-Market Surveillance|Post-Market Surveillance]]
# Want to help it grow?
* [[:Category:Labelling|Labelling]]
#* Check out [[Contribute_to_GxPlex|Contribute to GxPlex]] — there's a place for everyone, from occasional contributors to organizations ready to take it further.
* [[:Category:Traceability|Traceability]]
 
 
GxPlex only works because people like you bring their knowledge to it.
 
Thanks for stopping by — we hope you stay.


| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
=== Contribute ===
* [[Contribute_to_GxPlex|How to contribute]]
* [[Help:Adding_a_topic|Add a topic category]]
* [[Create_new_page|Create a new page]]
* [[GxPlex_Search|Find existing pages]]
|}


== Recent documents ==
== Recent documents ==

Latest revision as of 22:21, 19 July 2026

Welcome to GxPlex

Your shared map through the maze of clinical research regulations.


Whether you're a Study Coordinator double-checking an SAE reporting timeline for a Medical Device trial, a CRA preparing for an audit, or a small sponsor wondering what applies to your trial in a new country, GxPlex is built to help you find your way.

What you'll find here

GxPlex is a collaborative, wiki-style database of laws, regulations, and guidelines relevant to clinical research — covering international treaties (ICH, ISO, WHO...), EU regulations, and national requirements across Germany, Austria, France, the UK, and the US, with more to come.

Every reference is tagged so you can search and compare by country, research scope (IMP, Medical Devices, IVD...), document type, topic, and more.

Getting started

  1. New here?
  2. Curious about the story behind it?
  3. Want to help it grow?
    • Check out Contribute to GxPlex — there's a place for everyone, from occasional contributors to organizations ready to take it further.


GxPlex only works because people like you bring their knowledge to it.

Thanks for stopping by — we hope you stay.


Recent documents

 Document nameScopeRegionStatus
N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008(STROBE)statement: guidelines for reporting observational studiesINSN.A.N.A.
EU 2011/C 172/01 - CT-3 11-Jun-20112011/C 172/01 - CT-3GEUCurrent
USA 21 CFR Part 11 09-Apr-202521 CFR Part 11GUSACurrent
USA 21 CFR Part 312 09-Apr-202521 CFR Part 312HMUSACurrent
USA 21 CFR Part 314 09-Apr-202521 CFR Part 314HMUSACurrent
USA 21 CFR Part 320 09-Apr-202521 CFR Part 320HMUSACurrent
USA 21 CFR Part 50 09-Apr-202521 CFR Part 50GUSACurrent
USA 21 CFR Part 54 09-Apr-202521 CFR Part 54GUSACurrent
USA 21 CFR Part 56 09-Apr-202521 CFR Part 56GUSACurrent
USA 21 CFR Part 809 06-May-202421 CFR Part 809GUSACurrent
... further results

View all documents →

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