Medical equipmentThe industry continues to grow globally, especially in developed countries such as the UK, but for foreign manufacturers, entering the UK market requires a stringent set of regulations and processes.This article aims to provide a clear guide for those who intend to export medical devices to the UK market.

Determining product classification is the first step, and UK medical devices are classified on multiple levels according to the level of risk:

Class I Medical Devices:Usually refers to devices that do not come into contact with the human body or only come into contact with complete skin.
Class I-M Medical DevicesClass I medical devices with measuring functions.
Class I-S Medical DevicesClass I medical devices are presented on the market in sterile form.
Class IIa Medical Devices:The level of risk is slightly higher, such as the temporary use of invasive devices or source devices with energy exchanges.
Class IIb Medical Devices:Devices with potential risks to the human body or long-term use.
Class III Medical Devices:The risk is highest and is mainly used for the central circulatory system or the human brain.

After Brexit, the UK developed its own regulations for the management of medical products - UK MDR 2002, which are mainly based on the old EU directives. It is worth noting that to date, the UK still recognizes the EU MDR and EU IVDR regulations.

In order to sell medical devices in the UK market, foreign manufacturers must designate a UK Responsible Person (UKRP) in the UK.

(1) The timing of the procedure:As of January 1, 2022, all medical devices will have to complete MHRA registration before entering the UK market.
2) The process of processing:First, the company and product information is provided, then the two sides sign the UK Head Agreement, and finally the client puts the required documents in the UKCA technical documentation.
The cycle:The processing cycle is relatively fast, and once the trustee has collected all the necessary information and documents, both parties can quickly sign the agreement.

Any medical device must be registered with MHRA before it is placed on the UK market and must meet relevant regulatory requirements.

(1) The timing of the procedure:Registration in the UK is required before the name and address of the manufacturer and UK representative is printed on product labels and instructions.
2) The process of processing:First, fill out the application form and provide all necessary information, then the UK official submits the registration information to MHRA, and finally, after approval by the competent authorities, the UK official delivers the registration letter to the client.