Regulation (EU) 2024/1860 is on the Healthcare & Medical Devices rulebook because its official title matches medical device and in vitro diagnostic. Source: EUR-Lex and European Parliament procedure file; company-specific applicability still depends on your activities. Methodology
Regulation (EU) 2024/1860: what it means for Healthcare & Medical Devices
The Regulation (EU) 2024/1860 is part of the EU rulebook for healthcare & medical devices. Its subject matter covers medical device and in vitro diagnostic — core to the sector. Here’s what the act does, why it’s on your radar, and how to see whether it affects your specific company.
- Act
- 32024R1860
- Type
- Regulation
- Stage
- Procedure completed
- Dated
- 2024-06-13
- Procedure
- 2024/0021(COD)
- Lead committee
- ENVI
What the act does
to address risks of shortages of in vitro diagnostic medical devices in the Union and ensure the timely roll-out of Eudamed. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)) of the European Parliament and of the Council set a strengthened regulatory framework for medical…
Why it matters for Healthcare & Medical Devices
Healthcare, medtech and digital-health companies face EU rules on medical devices, diagnostics and health data. These are the EU acts most likely to apply.
Regulation (EU) 2024/1860 sits in that rulebook because its subject matter covers medical device and in vitro diagnostic. Whether — and how — it applies to a given business depends on that business’s activities, products and markets.
Does the Regulation (EU) 2024/1860 apply to your company?
This act’s scope covers:
- medical device
- in vitro diagnostic
Does your business touch any of these?
The rest of the Healthcare & Medical Devices rulebook
Monitor this regulation
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Primary sources
The act’s summary is the European Parliament’s own procedure record; the sector connection is the act’s stated subject matter. Lex shows the law and the grounded connection — not legal advice. Data © European Union (Decision 2011/833/EU). Methodology.