Medical Device Registration Services - United Kingdom
The UK Medicines and Healthcare products Regulatory Agency (MHRA)
Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)
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
England, Wales, Scotland (excluding Northern Ireland)
Conformity Assessment based on classification
* 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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