2021 is nearly upon us and changes are afoot!
Real Healthcare Solutions Ltd. will be supporting the UK Medical Device sector through the changes that will apply at the end of the Brexit Transition Period.
Do you know the answers to these questions?
What is the regulatory system going to look like next year, Post-Brexit
Do you need a UKRP to register with The Medicines & Healthcare products Regulatory Agency (MHRA)?
Put simply, if the medical device you are selling in the UK is manufactured outside of the UK, you will need to appoint a UK Responsible Person (UKRP) who has a registered place of business in the UK.
Real Healthcare Solutions Ltd. has now registered with the MHRA to be a UKRP.
Medical Devices placed on the Great Britain market will require registration with the MHRA subject to grace periods over the following 12 months, depending on the class of devices.
The UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.
If your medical devices were registered with the MHRA by an Authorised Representative based in Great Britain, your registration is no longer valid from 1 January 2021.
You will be required to appoint a UK Responsible Person and update your registration information with the details of the UK Responsible Person.
In addition, the MHRA plans to eventually replace the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.
We can help you meet these requirements. Quickly and effectively.