All companies planning to sell a medical or in vitro diagnostic (IVD) device in Great Britain need to register their product with the Medicines and Healthcare Products Regulatory Agency (MHRA). Different rules apply in Great Britain and Northern Ireland, and the following information addresses regulatory compliance in Great Britain (England, Scotland and Wales) only. Notably, there is a transition period during which a valid EU CE marking certification is accepted for the required conformity assessment evidence in Great Britain; however, all manufacturers must eventually comply with the U.K.-specific requirements for UKCA marking certification. The following information addresses the steps for UKCA marking and device registration with the MHRA.
The U.K. MHRA medical and IVD device approval process explained
The chart illustrates the MHRA approval process per device classification in the U.K. and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.
Determine the classification of your device according to the MHRA’s adopted classification rules.
Depending on your device classification, determine the appropriate conformity assessment route and implement a compliant quality management system (QMS). Most companies apply the EN ISO 13485 standard to achieve compliance.
Based on the device classification, prepare the technical file or design dossier as appropriate. For those classifications that require certification from a United Kingdom Approved Body (UKAB), engage a UKAB and submit the technical file or design dossier for review. Upon positive review, the UKAB issues the UKCA marking certificate.
Appoint a U.K. Responsible Person (UKRP) as well as a U.K.-based importer if the UKRP is not also acting as the importer.
Prepare a declaration of conformity and affix the UKCA marking.
The UKRP registers the device in the MHRA Device Online Registration System (DORS) and pays the application fee. The MHRA reviews the application and may request additional information.
Upon approval, the MHRA issues a registration confirmation letter for your device.
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This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for the United Kingdom when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.