In Vitro Diagnostic Regulation
The In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) establishes requirements for in vitro diagnostic medical devices placed on the EU market. It requires CE marking, notified body involvement for most device classes, and an EU Authorised Representative for non-EU manufacturers.
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In vitro diagnostic medical devices as defined in the Regulation, including devices intended for examination of specimens derived from the human body.
Requirements depend on the product, applicable legislation, and supply chain. This information is provided for general guidance and does not constitute legal advice.
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