Today the MHRA updated their Guidance: ‘Register medical devices to place on the market’
The update is to clarify that registration with the MHRA does not constitute “any form of accreditation, certification, approval or endorsement by the MHRA”.
Further, that registrants are “not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation”.
While the previous version of the guidance also had a similar statement, this update provides a clearer stance on the MHRA’s position. The prior version had softer language, stating “You should not claim this in any marketing materials, on the packaging or in the instructions for use.”
The MHRA registration is more of an administrative, rather than technical, process. The information provided in the application is limited, and devices must first be CE marked or UKCA marked before they can be registered. While the MHRA official has the right to ask for more information about the company or device, generally the registration process is simple and straightforward. It is not a substitute for the conformity assessment process, nor does the registration include an in-depth review related to the safety or efficacy of the device.
This is in line with other governmental agencies, such as the US FDA’s Logo Policy, which prohibits the use of the FDA’s logo by anyone in the private sector as “such use would send a message that FDA favors or endorses a private organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do.”
For more information, please read: UK Medical Device Registration
