MHRA Updates No-Deal Brexit Device Guidance
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday updated its no-deal Brexit guidance for medical devices, adding a new section on the role of the “UK Responsible Person.”According to the guidance, the UK Responsible Person, who must be established in the UK, acts on behalf of a non-UK manufacturer to carry out tasks for the manufacturer, which include registering with the MHRA before a device is placed on the UK market.
“Only a manufacturer or a designated UK Responsible Person can legally place a device on the UK market. This means that a single manufacturer may have several designated UK Responsible Persons,” MHRA explains, noting that such a UK Responsible Person must have documentary evidence supporting his/her position.
As far as responsibilities, 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. The person also must coordinate any requests between MHRA and the manufacturer and “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.”
Although the requirement for a manufacturer to have in place a UK Responsible Person is aligned with the grace period for registering devices with the MHRA, the regulator advises that manufacturers appoint a UK Responsible Person before the end of the grace period for post-market surveillance purposes. “Manufacturers will also need to take into consideration that they might need some time to establish a UK Responsible Person and draw up a mandate,” MHRA says.
In addition to the UK Responsible Person guidance, MHRA also has drawn up other guidance for device manufacturers from last February on everything from CE marking to labeling requirements to registrations.
MHRA Guidance