Medical Device Registration Services - United Kingdom

Regulatory Department

The UK Medicines and Healthcare products Regulatory Agency (MHRA)

Regulation

Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)

Regulatory Classification

  • Class I - generally regarded as low risk

  • Class IIa - generally regarded as medium risk

  • Class IIb - generally regarded as medium risk

  • Class III - generally regarded as high risk

  • In Vitro Diagnostic Medical Devices (IVDs) – List A & List B

Applicable Regions

England, Wales, Scotland (excluding Northern Ireland)

Registration Process

  • Conformity Assessment based on classification

  • UKCA Marking

* A Korean In-Country Caretaker is required to represent overseas medical device manufacturers. We will be able to manage this for you.

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