Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices is on the Healthcare & Medical Devices rulebook because its official title matches medical device. Source: EUR-Lex and European Parliament procedure file; company-specific applicability still depends on your activities. Methodology
Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices: what it means for Healthcare & Medical Devices
The Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices is part of the EU rulebook for healthcare & medical devices. Its subject matter covers medical device — 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
- 32022R0123
- Type
- Regulation
- Stage
- Procedure completed
- Dated
- 2022-01-25
- Procedure
- 2020/0321(COD)
- Lead committee
- ENVI
What the act does
to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices. 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: the unprecedented experience of the COVID-19 pandemic has demonstrated that the EU’s ability to coordinate work to ensure the availability of medicinal products and medical devices and facilitate their development is currently…
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) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices sits in that rulebook because its subject matter covers medical device. Whether — and how — it applies to a given business depends on that business’s activities, products and markets.
Does the Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices apply to your company?
This act’s scope covers:
- medical device
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.