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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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