On 24 April, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guideline Medical Devices: guidance for manufacturers on vigilance on the official government website. The purpose of this guideline is to inform Manufacturers, the Responsible Person (UKRP) and the Authorised Representative based in Northern Ireland on what they should do when reporting adverse incidents and the subsequent corrective actions to be taken.

The Manufacturer, UKRP and the Authorised Representative based in Northern Ireland are obliged to inform MHRA of any adverse incidents and Field Safety Corrective Actions (FSCAs), including Periodic Summary Reports (PSRs) and Trend Reports. Once reported, UKRP must analyse incidents and carry out previously declared corrective actions. In addition, it has to send the PSRs to the MHRA through the MORE portal, which has recently been activated.

Regarding the criteria for reporting adverse incidents, they must be reported to the MHRA if:

  • the event caused the death or serious deterioration in the health of a patient, user or other person;
  • the Medical Device is believed to be one of the causes of the incident that occurred;
  • an accident has occurred associated with a Medical Device, including situations that occurred during the performance of tests on the device.

With regard to reporting times, the Manufacturer, UKRP and Authorised Representative based in Northern Ireland are required to inform MHRA immediately. Specifically, in the case of a serious threat to public health, they must inform MHRA no later than 2 days after becoming aware of the incident, no later than 10 days in the case of death or serious deterioration, and no later than 30 days for any other adverse event. While the timing of PSR and trend reports must be agreed in advance with MHRA.

Finally, each report must be matched by a corrective safety action. Examples of corrective actions may be the return of a Medical Device to the supplier, i.e. recall, device inspection, device modification, destruction of the device, retrofit by the purchaser of the manufacturer’s change or design change, and changes in the use of the device or follow-up of patients, users or others declared by the manufacturer.

>>If you want to market Medical Devices in the UK, Thema can assist you with the Strategic Regulatory Consultancy, can be your UK Responsible Person (UKRP) and can support you in registering products with the MHRA.

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Guideline MHRA Medical Devices: guidance for manufacturers on vigilance