Legal manufacturers of medical devices wanting to market their device onto the Great Britain market (England, Wales, Scotland) will need to appoint a UK Responsible Person that is established in the UK.
ALPA Medical, through its UK office located in Hook (Hampshire), can now provide Services as UK Responsible Person.
As your UK Responsible Person, our responsibilities are to:
Be established in UK (entity and address).
Execute a written contract agreement between the parties
Register the Device(s) under agreement with the electronic system set-up by the Secretary of State
Act as the main point of contact for the Manufacturer
Allow the Manufacturer to indicate the name and address of the UK Responsible Person office on their label(s) and/or IFU(s) for the devices under agreement and for which they have affixed the UKCA Mark.
Verify the Declaration of Conformity and Technical Documentation have been drawn up
Check where applicable that an appropriate conformity assessment has been implemented
Keep the documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of the MHRA (UK Medicines and Healthcare Products Regulatory Agency)
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
Carrying out Post-Market Surveillance Activities as necessary
Where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
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 appointed
In case of Agreement termination, communicate to the MHRA and if applicable the Notified Body that issued the certification such termination and the associated reasons.