皇冠体育app

皇冠体育app Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory authority for the UK medical device market.

Once a medical device has been placed on the UK market, the manufacturer must submit reports to the MHRA when incidents that involve their device occur in the UK and meet the criteria for reporting (see Medical devices: post-market surveillance requirements).

皇冠体育app notification and evaluation of adverse incidents and FSCAs involving medical devices is known as the medical device vigilance system. 皇冠体育app guidance shows examples of incidents that manufacturers must report to the MHRA under this system.