A Step-by-Step Guide to UKRP

Purpose

Grace period for a UK Responsible Person

Starting from 1st January 2021, the UK MHRA has allowed 4 months grace period for Active implantable devices, Class III devices, Class IIB implantable and List A IVDs, 8 months for Class IIA devices, Class IIB non-implantable devices; 12 months for Class I devices and General List IVDs.

Key Responsibilities of a UK Responsible Person

The UK Responsible Person is responsible for the activities mentioned below:

  • Shall act on foreign manufacturer’s behalf and register the devices with the MHRA, before they are placed in the UK market
  • Shall ensure that all the device technical documentation and applicable declaration of conformity documents are in place for the device in scope and that the conformity assessment has been completed by the device manufacturer
  • Shall maintain copies of the original, amendment and supplements of technical documentation, the declaration of conformity and certificates. These documents should be readily available in case of the MHRA inspections
  • Shall be able to present the documents that ensure conformity of the device
  • Shall inform the foreign manufacturer immediately about the suspected incidents, complaints and reports received from healthcare professionals, patients and users
  • Shall cooperate with the MHRA for any corrective and preventive actions taken for mitigation or elimination of any identified risks posed by the devices
  • Shall either maintain samples or have access to the devices, in order to provide to the MHRA, on request. If not, UKRP shall forward the MHRA request for sample or access
  • Shall terminate the agreement with the device manufacturer in case of non-conformities with applicable regulations
  • Shall keep the MHRA and relevant Notified Body informed about the termination of agreement, if applicable

Registration responsibilities

The UKRP must first register the device with MHRA before placing it into the UK market. The UKRP must open a single registration account for the manufacturer that the UKRP is representing.

Post-market surveillance responsibilities

The manufacturer must determine if the UKRP will be having any responsibilities for the post-marketing surveillance. These responsibilities should be clearly mentioned to the UKRP at the initial stage of the discussion.

Location of the UK Responsible Person

The UKRP should have a registered office or place in the UK which will be used for all the official communications.

Qualifications and requirements for UK Responsible Person

There are no specific requirements for qualification set by the MHRA, as long as the UKRP is efficient enough to carry out the responsibilities which are defined by the MHRA.

Liability

According to the UK MDR 2002 (as amended by the UK MDR 2019) the MHRA UK Responsible Person is considered as a person who places the medical device in the UK market for the purposes of the Regulations. The UK MDR 2002 is a safety regulation for the reason of the Consumer Protection Act, there is a probability that the UK Responsible Person may be proceeded against under the Regulations or under the Consumer Protection Act 1987 if the UKRP fails to carry out any of its activities.

Resources

  • When should a medical device manufacturer appoint a UKRP and what is the associated legal basis?

    Know More
  • What are the varied roles of a UK Responsible Person?

    Know More
  • What are the routes to market Medical Devices in Britain and Norther Ireland (NI)? What are the UKRP solutioning models?

    Know More
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