Based in France, our client was a medical device company that develops and distributes implants dedicated to treating forefoot pathologies.
A well-established player in the UK market, the client was exporting Class IIb devices to the UK pre-Brexit, CE-certified under EU MDD.
As an EU device manufacturer the client needed to appoint a UK Responsible Person within the grace period to continue supplying the UK market.
Almost 150 SKU (Stock Keeping Units) needed to comply with UK MHRA requirements. Devices were of the same risk class with different GMDN codes.
As the appointed UK Responsible Person (UKRP) liaising with the UK Medicines and Healthcare products Regulatory Agency (MHRA), our goal was to provide hassle-free device registration within a short timeframe that ensured we prevented any disruption to the business.
Within 48 hours of being appointed as the UKRP for this client we had initiated device registration.
Details were updated to and successfully listed in the UK MHRA portal using a bulk upload template.
Full registration with the UK MHRA of all medical devices was completed within a one-week window.
As a registered UKRP we were able to ensure successful registration of the client’s medical devices without any interruption to their business workflow.
As a one-stop-shop for medical device manufacturers, we were able to deliver quick Turn-Around-Time (TAT) for device onboarding and registration.
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If you would like to speak to our team to discuss our UK responsible service, please enquire here.