EC Public Health · September 09, 2026

MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Original title: MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026)

Revised guidance on classification rules for IVD medical devices under the IVDR.

High obligation Framework Medical Devices & IVD EU-wide In vitro diagnosticsDevice classificationMedical devices

News announcement 9 September 2026 MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026) MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026) 1 min read

Dates and deadlines

Regulatory Deadline

September 09, 2026

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Published by EC Public Health. HealthSignal links to the original document; the summary above is extracted from the source text.