Labelling requirements and Post-market surveillance and vigilance

Labelling requirements:

Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under.

Where relevant, the number of the Approved Body or Notified Body must also appear on the label.

If you already have a valid CE marking on your device, you are not required to re-label the device with a UKCA marking until 1 July 2023 for placement on the Great Britain market. Devices can have both the CE and UKCA markings present on the labelling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).

Post-market surveillance and vigilance:

Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device. They must also take appropriate safety action when required. The manufacturer must ensure their device meets appropriate standards of safety and performance for as long as it is in use.

Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices.

Labelling requirements and Post-market surveillance and vigilance:

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