45 lines
1.9 KiB
Plaintext
45 lines
1.9 KiB
Plaintext
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.
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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.
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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.
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All registered users can contribute. New pages require reviewer approval before becoming publicly visible.
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== Quick navigation ==
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{| style="width:100%; border-collapse:collapse;"
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| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
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=== By document ===
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* [[Document_Index|All documents]]
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* [[Special:RecentChanges|Recent changes]]
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* [[Special:Ask|Custom query]]
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| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
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=== By scope ===
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* [[:Category:Medical Devices|Medical Devices (MD)]]
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* [[:Category:In Vitro Diagnostics|In Vitro Diagnostics (IVD)]]
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| style="width:33%; vertical-align:top; padding:0 1em 1em 0;" |
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=== By topic ===
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* [[:Category:Clinical|Clinical]]
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* [[:Category:Post-Market Surveillance|Post-Market Surveillance]]
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* [[:Category:Labelling|Labelling]]
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* [[:Category:Traceability|Traceability]]
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== Current documents ==
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{{#ask: [[Status::Current]]
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| ?Document name = Name
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| ?Scope = Scope
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| ?Area of validity = Region
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| format=table
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| headers=show
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| limit=10
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| sort=Scope
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}}
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[[Document_Index|View all documents →]]
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