UK MHRA Updates on Registration of Medical Devices for the Great Britain and Northern Ireland Markets
The Medicines and Healthcare products Regulatory Agency (MHRA) guides registering medical devices for placement on the Great Britain and Northern Ireland markets. The guidance covers the registration process, placing devices on the market, putting devices into service, importers, in vitro diagnostic devices (IVDs), fees, registration updates, and specific transitional arrangements for devices with expired or expiring CE certificates.
Registration for the Great Britain Market
The guidance explains the requirements for registering medical devices intended to be placed on the Great Britain market. It also distinguishes between placing a device on the market and putting a device into service and provides guidance on how these activities are treated for registration purposes.
Manufacturers are also provided with information on discontinuing devices and the requirements that apply when devices are no longer being placed on the market.
Registration for the Northern Ireland Market
Separate registration requirements apply to devices intended for the Northern Ireland market. The guidance explains the applicable registration arrangements and requirements for manufacturers placing medical devices on the Northern Ireland market.
It also covers specific registration provisions for different categories of medical devices and IVDs.
Registration of Importers
The guidance includes requirements relating to the registration of importers. Information is provided on when importer details need to be included as part of the device registration process.
Information Required for MHRA Registration
Manufacturers must provide relevant information when registering devices with the MHRA. The guidance explains the information required as part of the registration process and provides details on the information that needs to be maintained within the registration system.
IVDs Undergoing Performance Evaluation
Specific provisions are included for IVDs undergoing performance evaluation. The guidance explains the registration requirements applicable to these devices and the information that must be provided to the MHRA.
Coronavirus Test Device Approval and Registration
The guidance also covers Coronavirus Test Device Approval (CTDA) and the requirements for registering applicable coronavirus test devices with the MHRA.
Device Online Registration System
Manufacturers and relevant organisations can apply to register their devices through the Device Online Registration System (DORS). The guidance provides information on applying for registration and using the system to manage device registrations.
Fees and Registration Review
The guidance includes information on applicable registration fees and explains how manufacturers can review their registration information.
Manufacturers are also required to keep their registration details up to date. The guidance describes the process for making changes to an existing registration.
Transitional Arrangements for CE-Certified Devices
Specific registration arrangements are provided for certain medical devices with expired or expiring CE certificates.
The guidance also addresses certain EU MDD Class I reusable surgical instruments and EU MDD Class I medical devices that have been upclassified from Class I.
Separate provisions are included for certain IVD devices with expired or expiring CE certificates and for IVD devices that are upclassified from a general IVD device under the EU IVDR.
Public Register of Manufacturers
The guidance provides information on the public register of manufacturers. Registered manufacturer information is made available through the applicable MHRA public registration system.
Global Medical Device Nomenclature
The guidance covers Global Medical Device Nomenclature (GMDN) as part of the device registration process. The guidance explains its role in identifying and registering medical devices.
Reference Guides and Tutorials
The MHRA provides reference guides to support organisations with registration activities. These include an Account Management Reference Guide and a Device Registration Reference Guide.
The MHRA also provides video tutorials to help users understand and complete the registration process through the relevant MHRA systems.
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