Medical Device Registration

Medical Device Registration UK is mandatory for all manufacturers outside the UK are required to appoint a UK responsible person to place the device in Great Britain market (England, Wales and Scotland). Requirements are set out below separately for appointing a UK Head to market devices in Northern Ireland. No UK Responsible Person is required to be appointed by importers and distributors. However, the Device manufacturers should seek as soon as possible to appoint their UKRP.

In line with the above grace periods depending on the class of appliances, the authorized representative must then register appropriate appliances with MHRA. On behalf of the external UK manufacturer, the UK Responsible Person performs specific tasks relating to the manufacturer’s obligations. This includes recording the manufacturer’s equipment with the MHRA before the equipment can be placed on the UK market.

The UKRP must, in addition to the above requirements on registration:

• Make sure that the manufacturer has the latest conformity declaration and technical documentation.
• Maintain available a copy of the MHRA inspection technical documentation.
• Comply with all MHRA requests for these samples or device access. 
• Cooperate with MHRA to eliminate or mitigate the risks posed by devices in the event of any preventive or corrective step taken.
• Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations.