- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Manufacturer10
Conformity Assessment Body1
Plus 1 duty on the regulator, Crown ministers and public bodies — folded into the section list below.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Manufacturer — also bound by 502 other Acts
Measuring Instruments Regulations 2016
85 duties
Human Medicines Regulations 2012
75 duties
Conformity Assessment Body — also bound by 47 other Acts
Lifts Regulations 2016
28 duties
Radio Equipment Regulations 2017
27 duties
Explosives Regulations 2014
22 duties
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
uri:annex/i/division/1/division/1.1
uri:annex/i/division/1/division/1.1
Regulated
- Justify use of animal tissues in medical devices based on risk analysisManufacturer
uri:annex/i/division/1/division/1.2/division/1.2.3
uri:annex/i/division/1/division/1.2/division/1.2.3
Regulated
- Control sourcing of animal tissue and avoid high TSE risk materialsManufacturer
uri:annex/i/division/1/division/1.2/division/1.2.4
uri:annex/i/division/1/division/1.2/division/1.2.4
Regulated
- Minimise cross-contamination risk in animal tissue supply chainManufacturer
uri:annex/i/division/1/division/1.2/division/1.2.5/division/1.2.5.1
uri:annex/i/division/1/division/1.2/division/1.2.5/division/1.2.5.1
Regulated
- Control sourcing for devices that cannot withstand inactivationManufacturer
uri:annex/i/division/1/division/1.2/division/1.2.6
uri:annex/i/division/1/division/1.2/division/1.2.6
Regulated
- Evaluate animal tissue quantity and processing risk for each device unitManufacturer
uri:annex/i/division/1/division/1.2/division/1.2.7
uri:annex/i/division/1/division/1.2/division/1.2.7
Regulated
- Consider patient contact factors for animal-derived medical devicesManufacturer
uri:annex/i/division/1/division/1.2/division/1.2.8
uri:annex/i/division/1/division/1.2/division/1.2.8
Regulated
- Consider route of administration in risk assessmentManufacturer
uri:annex/i/division/1/division/1.3
uri:annex/i/division/1/division/1.3
Regulated
- Set up a system to monitor device safety after products are on the marketManufacturer
uri:annex/i/division/2/division/2.1
uri:annex/i/division/2/division/2.1
Regulated
- Notify approved body of changes affecting TSE risk assessment before implementationManufacturer
uri:annex/i/division/2/division/2.2
uri:annex/i/division/2/division/2.2
Regulated
- Approved body must review key aspects before extending certificate for animal-tissue devicesConformity Assessment Body
uri:annex/i/division/2/division/2.3
uri:annex/i/division/2/division/2.3
Regulated
Other duties (1) — Crown / regulator
- Approved body must follow Article 5 procedure when TSE risk increasedStatutory regulator
s.art005
(1) Conformity assessment procedures for medical devices referred to in...
Regulated
- Monitor and report changes to animal tissue or TSE risk to your approved bodyManufacturer
9 other provisions — procedural and definitional
uri:annex/i/division/1/division/1.2/division/1.2.5/division/1.2.5.2
uri:annex/i/division/1/division/1.2/division/1.2.5/division/1.2.5.2
s.art001
(1) This Regulation lays down particular requirements in relation to...
s.art002
For the purposes of this Regulation, the following definitions apply...
s.art003
(1) Before lodging an application for a conformity assessment for...
s.art004
(1) The Secretary of State must verify on a regular...
s.art006
Without prejudice to Article 7(2), Member States shall take all...
s.art007
(1) Holders of EC design-examination certificates or EC type-examination certificates...
s.art008
Directive 2003/32/EC is repealed with effect from 29 August 2013....
s.art009
This Regulation enters into force on the twentieth day following...
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.