UK Medical Devices Regs 2002in-force
The Medical Devices Regulations 2002 (SI 2002/618)
UK-2002-618
Applies from 2002-06-13
Summary
UK medical devices base regulations (implementing MDD/AIMDD/IVDD, as amended): CE marking, conformity assessment, MHRA registration.
Scope
Applies to medical devices, active implantable medical devices and in vitro diagnostic devices placed on the UK market (as amended). Requires CE marking (transition), MHRA registration, conformity assessment and vigilance reporting.
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