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UK Responsible Person

  • We have a dedicated UK responsible person for launching products in the UK
  • We have a deep understanding of Medical Devices and its market.
  • Our expertise to support the compliance and regulatory needs of our customers
  • We can support your knowledge gaps with trainings, regulatory updates.

What will be our responsibility?

  • We will need to register relevant devices with the MHRA in line with the grace periods depending on the device class.
  • We will act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.
  • Ensure that the declaration of conformity and technical documentation has 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, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
  • Provide samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.
  • 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 designated.

How can we help?

GemarMed’s regulatory and quality assurance expertise and experience allow us to offer our services as an outsourced UK RP for micro and small companies or train your internal UK RP in your organization. Given the necessary authority, accessibility, and other required resources, companies may capitalize on our long-standing and proven track record in successfully designing, applying, and internally auditing the various aspects of regulatory affairs governing medical devices in UK market.

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