U.K Responsible Person

U.K Responsible Person

➡️ 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 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/AsphalionSL@asphalion.onmicrosoft.com/bookings/

➡️ You can also contact us at: ukrp@asphalion.com

We will be happy to help you!

 

WHITE PAPER | Impact of MDR on Directive 2001/83/EC: What you need to know
Symposium AEFI 2021