What Institution is responsible for regulating and supervision of medical devices in the United Kingdom?
The institution responsible for regulating medical devices in the UK is Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland.
What is the UKCA marking?
The UKCA is a new product marking that is required for certain products being place on the UK market. It covers most of the products that previously required the CE mark.
What is the classification and conformity assessment routes in the UK?
Medical devices in the UK are classified into class I, IIa, IIb or III.
Medical devices classified into the class I with sterile function or measuring function, class IIa, IIb, and III must be approved and certified by an Approved Body (located within the UK).
Medical devices that meets the UK Regulations (UK MDR 2002) requirements by carrying out a conformity assessment can be market with UKCA.
What are the responsibilities of the UK Responsible Person?
If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a registered place of business in the UK. The UK Responsible Person will take over the manufacturer’s obligations to register the device with the MHRA and will provide:
- availability and updating of technical documentation upon MHRA’s request,
- completion of the conformity assessment,
- preparation and correctness of the declaration of conformity (DoC),
- provision of technical information on products and product samples upon request by MHRA.
MDR Regulator can help you with designation the UK Responsible Person.
What is the registration process of medical devices in the UK?
All the classes of medical devices must be registered with the MHRA.
The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business in the UK, or from Authorized Representatives based in Northern Ireland.
Importers are not required to register with the MHRA.
In cases where the UK importer is not the UK responsible person, the importer must inform the UK responsible person of the intention to import the device.
In these cases the UK responsible person must provide the MHRA with a list of equipment importers.
How can we help?
Contact us if you intend to export products to the UK market and need to appoint a UK Responsible Person (UKRP) or need a support in documentation compliant with UK medical device law requirements.