UK Responsible Person (UKRP)
Medical Devices, Cosmetics and more
Medical Device UKRP - UK Responsible Person
UKRP stands for United Kingdom Responsible Person for medical devices. The medical device UK Responsible Person, also known as UKRP, acts on behalf of the non-UK manufacturer of medical devices. The UK Responsible Person carries out specific tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s medical devices with the MHRA before the medical devices can be placed on the Great Britain market.
Medical device manufacturers located outside the United Kingdom (UK) and without any local business offices, shall appoint a United Kingdom Responsible Person. The UKRP will make the device registration and launch of the device in the United Kingdom.
Responsibilities of the Responsible Person:
Ensure that the medical device declaration of conformity and technical documentation of the medical devices have been drawn up. Where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
Keep available a copy of the technical documentation of the medical devices, a copy of the declaration of conformity. 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. Also, provide the MHRA with all the information and documentation of the medical device necessary to demonstrate the conformity of a device
Where they have samples of the devices or access to the medical device, comply with any request from the MHRA to provide such samples or access to the device.
Where they have neither samples of the medical device nor access to the device, communicate to the medical device´s manufacturer any request from the MHRA to provide such samples or access. Communicate to the MHRA whether the medical device's 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 medical devices
Immediately inform the medical device´s manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
If the medical device´s manufacturer acts contrary to its obligations under these Regulations:
terminate the legal relationship with the medical device´s manufacturer, and
inform the MHRA and, if applicable, the relevant Approved Body of that termination.
We offer medical device UKRP and UK Medical Device 2002 consulting, medical device Regulatory and Quality consulting services and import solutions. Along with medical device regulatory consulting with our partners located around the world. Also, we are certified for Medical Devices under MDR 2017/745, for Invitro Diagnostics under IVDR 2017/746. Also for the old MDD, AIMD and IVDD certifications, and we will help every non-UK medical device manufacturer to go to the UK market acting as they UKRP!
If you are looking for advice in UKCA mark do not hesitate in contacting us! We provide support in the obtention of the UKCA marking and registering you devices in the MHRA acting as your UK Responsible Person (UKRP).
Who can Act as a Responsible Person?
Any third-party entity or an importer or distributor can act as a UK Responsible Person on foreign medical device manufacturer’s behalf. The appointed UK Representative shall register with the MHRA.
What are the Labeling Requirements in the Context of UKRP?
The name and address of the United Kingdom Representative shall be included on the label of a UKCA marked medical device, w.e.f. 1st, January 2021.
Do not miss our medical device EU Authorized Representative and EUDAMED registration services too. We can provide you a better quote, choosing both services.
As UK Responsible Person, UKRP, we had been trained for UKCA marking
AF Pharma Service acting as UK Responsible Person (UKRP) not only does it provide the mandatory services determined for the UKRP in the MHRA website, but it also helps to create the correct regulatory strategy for the client. We work with medical devices, in vitro diagnostics, cosmetics, nutraceuticals, machinery and other health products. We provide our complete UK Responsible Person (UKRP) services to the client, ensuring that regulatory requirements are understood and met in order to be in the UK market.
We had been approved by the MHRA to act as UK Responsible Person (UKRP).
The UK Responsible Person (also referred to as an UKRP or UK Rep) is a mandatory economic operator for every Non-UK manufacturer. With the new MHRA implemented, choosing the correct UKRP is the main task for any manufacturer.
We are register in the MHRA and UK Authorities to act as UK Responsible Person, UKRP, for:
- medical devices
We can help you with the UKCA marking and MHRA (UK) registrations!
Contact us for the best quote.