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TECH-DOC
QM System
Tools
Basic UDI-DI
Classification
Declaration of conformity
Intended Purpose
Significant Change
Consulting
Knowledge
Downloads
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IVDR
Glossary
MDR
IVDR
Articles
Harmonised Standards for IVDR and MDR
IVDR with links
Learning from the Team-NB survey 2021
List of views provided under the PECP
MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
Rule 5: IVD or not IVD?
