Main Page: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) Replace default installer content with wiki-appropriate main page |
Gxplex admin (talk | contribs) Expand introductory description on Main_Page |
||
| Line 1: | Line 1: | ||
This wiki is a structured reference database for regulatory documents and | 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 pages for its key articles, annexes, and provisions, organized by topic. | ||
The database currently covers regulations, directives, and guidelines in the MD, IVD, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly, for example between MDR and IVDR requirements on post-market surveillance or UDI. | |||
Structured queries are available on the [[Document_Index|Document Index]] and on each category page. Use [[Special:Ask|Special:Ask]] for custom queries across any combination of scope, status, region, or topic. | |||
All registered users can contribute. New pages require reviewer approval before becoming publicly visible. | |||
== Quick navigation == | == Quick navigation == | ||
Revision as of 14:43, 4 June 2026
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 pages for its key articles, annexes, and provisions, organized by topic.
The database currently covers regulations, directives, and guidelines in the MD, IVD, GMP, PV, and NIS scopes. Cross-references between equivalent provisions in different regulations are maintained explicitly, for example between MDR and IVDR requirements on post-market surveillance or UDI.
Structured queries are available on the Document Index and on each category page. Use Special:Ask for custom queries across any combination of scope, status, region, or topic.
All registered users can contribute. New pages require reviewer approval before becoming publicly visible.
By document |
By scope |
By topic |
Current documents
| Name | Scope | Region | |
|---|---|---|---|
| In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 | In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 | IVD | EU |
| TestPage MDR | Medical Device Regulation (EU) 2017/745 | MD | EU |
