Details about the Regulation of Medical Devices in Case of No-Deal Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) publishes guidance about registration fees and requirements for a No-Deal Brexit

These include, among others, legislative information, information about CE Marking and labeling requirements and also details about registrations:

The registration requirements apply for products that will be placed on the market post Brexit. Depending on the classification of a device, transition periods between four and twelve months apply. 

The guidance says that a fee of £100 incurs per registration application and also for new and changes to existing registrations. The requirements also provide for renewals of the registration one year after the initial registration application, and every two years after. The renewal will be charged with £100 as well.

Please bear also in mind that manufacturers outside the UK wishing to place their products on the UK market, must appoint a UK Responsible Person. The role refers to the EU Authorized Representative in the remaining EU 27 countries.

Source: MHRA

Visit the website of Medicine & Healthcare products Regulatory Agency, to read the whole article.

If you require further information on Brexit or appointing the UK Responsible Person

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