UKRP News Update, 20th March 2023
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.
The regulatory framework for medical devices in the United Kingdom (excluding Northern Ireland) continues to be subject to significant change. To help you plan for the months ahead we have prepared the following items of interest for your consideration should you wish to supply your devices into the UK after 1st July 2024. Please note that this is an ever-changing situation.
Introduction of the UKCA mark for medical devices.
From 1st June 2024, the CE mark will no longer be recognised on medical devices being supplied into the UK. Any devices which are have already been imported can still be sold/used as they complied with the regulation when they first entered the UK. The actions you take following the 1st June 2024 vary by the class of device.
Class I non active, non-sterile, non-measuring – existing devices will have already been registered with the MHRA therefore just need a UK Declaration of Conformity drawn up.
Class I (active, sterile, or measuring), Class IIa, Class IIb, and Class III – these devices will all need to have a technical file review conducted by a UK Approved Body before they can be registered for sale on the UK (excluding Northern Ireland) market.
At present there are only 4 UK Approved Bodies designated in the UK (see below), although there are others currently undergoing designation. Note that the scope covered by each approved body varies, so you will have to use a body relevant to your type of device.
As there are going to be a lot of manufacturers looking to obtain a UKCA mark for their devices (both in and out of the UK) we recommend that you start to think about how you plan to manage this as it will not be a quick process. Our regulator in the UK (MHRA) may provide updates in the months ahead, and if they do we will communicate these to you.
MDD to MDR
In addition to the requirements to have a UKCA mark there is also the change to have devices certified against MDR. If you are currently using an MDD certificate to import in to the UK and this is due to expire for replacement by MDR then we must undertake a new registration application for your products. This would require submission to us, as your UKRP, of all relevant technical documentation.
If you have any questions, please contact us via ukrp@qcsl.co.uk
UKRP Service and Supporting your compliance
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 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
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible
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 ukrp@qcsl.co.uk or call on +44 1236 734447 or complete the form below.