➡️ Since January 1st, 2021, Medical Device manufacturers located outside the United Kingdom and without any local business offices shall appoint a United Kingdom Responsible Person (UKRP), on their behalf, as a pre-requisite for device registration and launch of the device in the United Kingdom. The UKRP acts as the point of contact between a manufacturer located outside the UK and the UK´s Medicines and Healthcare products Regulatory Agency (MHRA).
➡️ Have a look at the infographic we have prepared that summarizes the Medical Devices legal framework in UK after BREXIT, as well as the responsibilities of the UK Responisble Person and how Asphalion can help you, through its office in London, acting as your UKRP, fulfilling all obligations and keeping your Regulatory interests up to date. We have already started delivering this service to our customers and can help you along the way.
☑️ In case you would like to know more about this service, you can contact us at: