info@wiselink.com.au
1300 76 80 90
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
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Class I - generally regarded as low risk
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Class IIa - generally regarded as medium risk
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Class IIb - generally regarded as medium risk
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Class III - generally regarded as high risk
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In Vitro Diagnostic Medical Devices (IVDs) – List A & List B
Applicable Regions
England, Wales, Scotland (excluding Northern Ireland)
Registration Process
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Conformity Assessment based on classification
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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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Looking to register your medical device in Canada? Contact us today!
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