Council Directive (EU) 2020/2020 of 7 December 2020 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
Council Directive (EU) 2020/2020 of 7 December 2020: what it means for Healthcare & Medical Devices
The Council Directive (EU) 2020/2020 of 7 December 2020 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
- 32020L2020
- Type
- Directive
- Stage
- Procedure completed
- Dated
- 2020-12-07
- Procedure
- 2020/0311(CNS)
- Lead committee
- ECON
What the act does
to amend the VAT Directive to ensure more affordable access in the EU to supplies of COVID-19 vaccines and in vitro diagnostic medical devices in response to the pandemic. 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 aim of the Union's strategy on COVID-19 vaccines is to accelerate the development, manufacture and deployment of vaccines against the virus in order to help protect people in the Union. An effective and safe COVID-19 vaccine is considered the most likely durable…
Read the full Council Directive (EU) 2020/2020 of 7 December 2020 explainer →
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.
Council Directive (EU) 2020/2020 of 7 December 2020 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 Council Directive (EU) 2020/2020 of 7 December 2020 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
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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.