Services â Healthcare â
UK Responsible Person
As your UK Responsible Person, Obelis UK Ltd. will:
- Register devices with MHRA
- Ensure technical documentations have been drawn up
- Keep a copy of technical documentations for inspection
- Cooperate and Provide MHRA all information upon request
- Inform the manufacturer of complaints and incidents
- Represent the manufacturer
Do not lose grip over your devicesâ applicable regulatory regime, and let usâŠ
- Make your journey through the UK market smooth!
- Alleviate your importersâ obligations becoming your sole UK RP and easing your market access!
- Inform you about any regulatory change of impact to your devices!
- Advise you on following the CE mark or UKCA mark path when accessing the market!
Considering that in Great Britain medical devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), note the following:
- In order to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person that is established in the UK;
- In cases where the Great Britain importer is not the UK Responsible Person, the importer must inform the relevant UK Responsible Person of their intention to import a device.
The UK Responsible Person must:
- Provide the MHRA with a list of device importers;
- Register relevant devices with the MHRA, deadlines vary depending on devicesâ type (See UK services content);
- Where a medical device was already registered with the MHRA, it does not need to be re-registered. However, the UK Responsible Person is required to review the information held by the MHRA to ensure it remains correct in line with the above dates;
- Act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturerâs obligations. This includes registering the manufacturerâs devices with the MHRA before the devices can be placed on the Great Britain market;
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA;
- In response to a request from the MHRA, the UK Responsible Person must provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device;
- Where they have samples of the devices or access to the device, the UK Responsible Person must comply with any request from the MHRA to provide such samples or access to the device;
- Where they have neither samples of the device nor access to the device, the UK Responsible Person must communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request;
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed.
Device Registration in the UK: Deadlines
Since 1 January 2021, all medical devices and in vitro diagnostic medical devices need to be registered with the MHRA before being placed on the UK market.
However, the registration of medical devices is staggered depending on the risk class of the devices:
- Registration by 30 April 2021 for high risk devices:
Class III, IIb implantable devices and AIM devices & IVD List A - Registration by 31 August 2021 for medium risk devices
Class IIa and IIb non-implantable medical devices  & IVD List B and Self-testing - Registration by 31 December 2021 for low risk devices
Class I medical devices  & general IVDs
UKCA Mark
Manufacturers will need to apply changes to their labels when placing them on the GB market. This includes the new UKCA Mark and the UK RP details on the label at the latest when the UKCA mark appears.
It is important to remember that devices bearing CE mark will not be required to be relabeled with the UKCA until 1 July 2024. Furthermore, CE marking will be allowed to continue to appear on the label of devices made available on the GB market. This means that devices that bear a dual mark on their label can continue to be sold on the GB market even after 1 July 2024 by virtue of carrying the UKCA mark.
- A UKCA mark is a logo that is affixed on medical devices to show they conform to the requirements in the UK MDR 2002;
- It shows that the device is fit for its intended purpose stated and meets applicable legislation requirements;
- It shows the product can be freely marketed in Great Britain (England, Wales and Scotland) The UKCA mark will not be recognised on the Northern Ireland nor EU market. A CE mark or CE UKNI mark will be needed for devices placed on the Northern Ireland market.
You must sign a âdeclaration of conformityâ before placing the UKCA mark on your product.
An identification number for an UK Approved Body needs to be placed below the UKCA mark if it has been involved in the conformity assessment for certain higher-risk devices Class Is, Im, IIa, IIb, III, self-test IVDs, Annex II IVDs).
The UK government has set up a new domestic UK database to replace the EUâs NANDO (New Approach Notified and Designated Organisations) Information System where you can find the UK Approved Bodies.The initial deadline for the use of UKCA was 30 June 2023.
However, in November 2022, the UK government extended it until 30 June 2024. Hence, from 1 July 2024, a UKCA mark will be required in order to place a medical device on the Great Britain market. Furthermore, the UK is working on a new law that will likely foresee a longer transition period.
You should not place a UKCA mark on your medical device if it is:
- A custom-made device â although it must still meet the requirements in the UK MDR 2002 and the type of device should be labelled clearly;
- Undergoing a clinical investigation â it must include âexclusively for clinical investigationâ;
- An in-vitro diagnostic medical device (IVD) for performance evaluation;
- A non-compliant device used in exceptional circumstances (humanitarian grounds)
No third-party intervention is needed in above cases, but you need to for ex. draw up a statement to declare the compliance for custom-made devices, clinical investigations and performance evaluation devices.
Would you like to place medical devices on the UK market? Contact us, and we will guide you through the process!
Obelis UK is certified according to the international standards ISO 9001:2015 and ISO 13485:2016 for representative and consulting services.
Our regulatory affairs consultants are committed to deliver the most efficient compliance process and support manufacturers to safely place their products on the UK market.
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