Representation
UK Responsible Person
Legal manufacturers of medical devices wanting to place their device on the Great Britain market (England, Wales and Scotland) will need to appoint a UK Responsible Person that is established in the UK.
ALPA Medical, through its UK office in Hook (Hampshire), provides services as a UK Responsible Person.
What we take on
As your UK Responsible Person, our responsibilities are to:
- Act as the single, exclusive UK Responsible Person for the manufacturer
- Register the manufacturer’s devices with the MHRA before they are placed on the Great Britain market
- Maintain a registered UK place of business for the service of documents and official communications, and remain contactable
- Hold a signed letter of designation from the manufacturer setting out the agreed tasks
- Ensure that the Declaration of Conformity and technical documentation have been drawn up
- Ensure that an appropriate conformity assessment procedure has been carried out, where applicable
- Keep a copy of the technical documentation, the Declaration of Conformity and any certificates, including amendments and supplements, available for MHRA inspection
- Provide the MHRA, on request, with all the information and documentation needed to demonstrate the conformity of a device
- Comply with MHRA requests to provide samples of the device or access to it, where held
- Where samples or access are not held, pass the MHRA’s request to the manufacturer and tell the MHRA whether it intends to comply
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
- Immediately inform the manufacturer of complaints and reports of suspected incidents from healthcare professionals, patients and users
- If the manufacturer acts contrary to its obligations, terminate the relationship and inform the MHRA and, where relevant, the approved body
Get in touch
Placing devices on the GB market?
We can act as your UK Responsible Person through our UK office in Hook, Hampshire, and be your main point of contact with the MHRA.