All options must apply to you:

  1. A MD and/or IVD manufacturer?

  2. Located outside UK?

  3. Selling to the UK?

UK Responsible Person

UK Responsible Person

Since 1 January 2021, non-UK based Medical Device and IVD manufacturers who want to sell in Great Britain (England, Wales and Scotland) must appoint a UK Responsible Person (UKRP). The role of a UKRP is to register your device(s) with MHRA, thus ensuring legal and easy access to the Great Britain market.

Any of the following devices wishing to be sold in Great Britain need to be registered with the MHRA now:

  • New MDs and IVDs placed on UK market for the first time

  • Class III medical devices

  • Class IIb implantable medical devices

  • active implantable medical devices

  • IVD List A products

Although all other classes of device have their own grace period of registration with the MHRA, medical device manufacturers should seek to appoint a UKRP as soon as possible. Psephos offers the option to complete full registration for all your devices at the same time, though each device is subject to different grace periods. There is no legal obligation to do so however this will avoid extra time spent, and extra application costs further down the line for the Client.

As a UK Responsible Person we will commit to the following (as in line with UK MDR 2002):

  • ensure that the Client has put in place an appropriate declaration of conformity along with the correct technical documentation for their product and, where applicable, that an appropriate conformity assessment procedure has been applied;

  • register the Client’s devices with the MHRA;

  • keep available a copy of the Client’s technical documentation, a copy of the declaration of conformity and, if applicable, a copy of relevant certification, including any amendments and supplements for inspection by the MHRA;

  • in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a Client’s device;

  • respond to requests from the MHRA and forward any MHRA requests for samples or access to a device to the Client ensuring that the MHRA requests are fulfilled;

  • cooperate with the MHRA on any preventive or corrective action (CAPA) taken to eliminate or, if that is not possible, mitigate the risks posed by Client’s devices;

  • immediately inform the Client about complaints and reports from healthcare professionals, patients and users about suspected incidents related to one of their devices.

Why appoint Psephos to be your UK Responsible Person?

  • 20+ years of experience and integrity working within UK Health infrastructure

  • Dedicated and supportive UK Responsible Person Department

  • Independent consultancy with no conflict of interest

  • Quotations are bespoke with no unexpected or hidden fees

  • Insurance to cover liability

  • Registered place of business in Brighton, UK

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When you get in touch with us you will be asked to confirm the number of devices that you would like to register, and how many technical files that would involve. Once we receive this information, we will provide you with a tailored quotation and support you with any questions that you may have. 

 

Registration Timeline

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