uri:annex/i/division/1/division/1.1
- Justify use of animal tissues in medical devices based on risk analysis
Retained EU Law
2012
United Kingdom
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)
At a glance
What's here
12 compliance obligations
Who this Act binds
Plus 1 non-business duty on Crown ministers, regulators, local authorities or tribunals — shown collapsed under each section below.
What this Act requires
Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.
uri:annex/i/division/1/division/1.2/division/1.2.3
- Control sourcing of animal tissue and avoid high TSE risk materials
uri:annex/i/division/1/division/1.2/division/1.2.4
- Minimise cross-contamination risk in animal tissue supply chain
uri:annex/i/division/1/division/1.2/division/1.2.5/division/1.2.5.1
- Control sourcing for devices that cannot withstand inactivation
uri:annex/i/division/1/division/1.2/division/1.2.6
- Evaluate animal tissue quantity and processing risk for each device unit
uri:annex/i/division/1/division/1.2/division/1.2.7
- Consider patient contact factors for animal-derived medical devices
uri:annex/i/division/1/division/1.2/division/1.2.8
- Consider route of administration in risk assessment
uri:annex/i/division/1/division/1.3
- Set up a system to monitor device safety after products are on the market
uri:annex/i/division/2/division/2.1
- Notify approved body of changes affecting TSE risk assessment before implementation
uri:annex/i/division/2/division/2.2
- Approved body must review key aspects before extending certificate for animal-tissue devices
uri:annex/i/division/2/division/2.3
Other duties (1) — Crown / regulator
- Approved body must follow Article 5 procedure when TSE risk increased Statutory regulator
(1) Conformity assessment procedures for medical devices referred to in...
- Monitor and report changes to animal tissue or TSE risk to your approved body
Browse 9 other sections — procedural / definitional / commencement
uri:annex/i/division/1/division/1.2/division/1.2.5/division/1.2.5.2
(1) This Regulation lays down particular requirements in relation to...
For the purposes of this Regulation, the following definitions apply...
(1) Before lodging an application for a conformity assessment for...
(1) The Secretary of State must verify on a regular...
Without prejudice to Article 7(2), Member States shall take all...
(1) Holders of EC design-examination certificates or EC type-examination certificates...
Directive 2003/32/EC is repealed with effect from 29 August 2013....
This Regulation enters into force on the twentieth day following...
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