UK Responsible Person For Medical Devices

According to current UK regulations, the only way for non-UK manufacturers to sell their devices in the United Kingdom is through the use of a UK Responsible Person. The UKRP must be based in the UK and conduct specific duties on behalf of the manufacturer, such as registering medical devices with MHRA, the regulatory authority before they are put on the UK market.

The I3CGlobal team will help you gain access to the medical device market in the United Kingdom if you are a medical device manufacturer. Our top-class regulatory team will provide UK Responsible Person service from our UK-registered offices.

Scope of UKRP

  • Providing any complaints or vigilance reports received in the UK to the producer.

  • As required, communicating with the UK regulatory authority

  • Document retention and submission to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as needed

  • Meetings with the manufacturer to discuss service issues

  • Technical Documentation and Clinical Evaluation.

  • Device Classification and Risk Benefit Analysis.

Until June 30, 2023, the UKRP’s name and address do not need to be on the device packaging.

Prior to July 1, 2023, devices will have both the CE and the UKCA marks on their labelling, and dual marking will be accepted on the Great Britain market after that date.

Yes, indeed. UKRP will need a hard copy or an electronic copy. This is needed in order to respond to the MHRA, as well as for vigilance and accidents.

The GMDN Code must be entered during the registration process. The registration of the device cannot be completed without the GMDN code. If a manufacturer does not have a GMND code, the I3CGlobal team will find GMDN codes for customers.

MHRA Registration Deadline

Date of Registration

Medical Devices

In Vitro Devices

1st January 2021

The first time the UK Marketed all devices

The first time UK Marketed all IVD

1st May 2021

Class III & Class IIb Implants

Annex II and List A

1st September 2021

Class IIb and Class IIa

List B and Self-Test

1st January 2021

Class I

General

1st July 2023

UKCA Mark MUST

UKCA Mark MUST

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