The medicines and healthcare regulatory agency (MHRA) is responsible for regulating the UK medical devices market.
In Great Britain devices must conform to UK MDR 2002, the EU MDR (until 30 June 2023), 0r the EU IVDR until 30 the June 2023) in order to be registered with the MHRA.
Manufacturers based outside the UK must appoint a single UK responsible person who will take responsibility for the product in Great Britain.
With Partner offices in Great Britain, Lexium’s team in GB has the expertise to help you navigate MHRA’s regulatory requirements and begin selling your device in GB.UK Responsible Person
The UK responsible person acts on behalf of the outside UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. The responsibilities of the UK responsible person are set out in the UK MDR 2002. In addition to the above registration requirements the UK responsible person must Ensure that the declaration of conformity and technical documentation have 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 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.
Where they have samples of the device or the access to the device, comply with any request from the MHRA to provide such samples or access to the device.
Cooperate with the MHRA on any preventive or corrective actions taken to eliminate or, if that is not possible, mitigate the risks posed by device.
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which that have been appointed.
Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which that have been appointed.If the manufacture acts contrary to its obligations under these regulations:
Terminate the legal relationships with the manufacturer; and Inform the MHRA and, if applicable, the relevant approved body of that termination.
The name and address of the UK responsible person, where applicable, must be included on product labelling where the UKCA mark has been affixed.Let Lexium assist you with your Great Britain’s Regulatory Approval Process
Lexium assists manufacturers to identify the device classification as a first step. Lexium helps client in procuring certification such as INMETRO and BGMP by helping in rectifying the regulatory hassles involved. Our partner companies are having vast experience in launching numerous devices in the region.
Lexium supports the foreign manufacturers in start to end medical device life cycle management, including post approval activities such as:
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