➡️ From September 1st 2021, Class IIb Non-implantable MDs, Class IIa MDs, List B IVDs, Self-test IVDs, as well as custom made devices according to device class should be registered with MHRA to be placed in the UK market.
☑️ The UK Responsible Person acts on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
☑️ As of today, Asphalion, through its office in London can act 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 schedule a free 30 minutes consultation meeting at the Medical Devices calendar here:
https://outlook.office365.com/owa/calendar/[email protected]/bookings/
➡️ You can also contact us at: [email protected]
We will be happy to help you!
