UKRP News Update, 01st March 2021.
The UK has left the European Union with a trade deal that requires non-UK manufacturers to appoint a UK Responsible Person for the medical devices they wish to sell within the UK market (this also applies to manufacturers from other parts of the world). QCS International is registered with the MHRA (Registration number 11356) to offer a UK Responsible Person service.
QCS understands the importance of this service for non-UK based companies who wish to retain access to the UK market. We are now successfully registering devices on behalf of our clients who are now meeting all regulatory requirements of the UK marketplace.
Our UK responsible Person Scheme is headed by our Medical Device Expert, Dr Edward Staunton. We have over 15 years’ experience in the field of regulations regarding medical devices and are at the forefront of regulatory compliance post-Brexit.
Our Service includes:
- Access to individuals with expert knowledge in regulatory compliance
- Registration using QCS International as your responsible person
- Vigilance tracking and reporting including communication with relevant interested parties
- Maintaining document files for questions arising from the MHRA
- General regulatory correspondence in the UK as required
This service conforms fully with the requirements of the MHRA guidance
For further information on UKRP services and how QCS could help with registration of devices in the UK please feel free to get in touch .
For a discussion on how we can help you plan for Brexit please contact email@example.com or call on +44 1236 734447 or complete the form below.