UK market access and vigilance
This section sets out the regulatory status of the device in the United Kingdom, the identity of the UK Responsible Person, and how to report a serious incident involving a device placed on the UK market.
Regulatory status in Great Britain
The device is CE marked under Council Directive 93/42/EEC (MDD) and is classified as Class I under that Directive.
It is placed on the Great Britain market on the basis of that CE marking, under the transitional arrangements, and not on the basis of a UKCA marking.
The manufacturer is in the transition provided for by Article 120(3b) of Regulation (EU) 2017/745. The MDD Declaration of Conformity remains valid and a written agreement is in place with the notified body BSI.
CE marking on this basis is accepted in Great Britain until 30 June 2028.
Manufacturer registration with the MHRA
The manufacturer is registered with the Medicines and Healthcare products Regulatory Agency (MHRA).
- Legal manufacturer: AI Labs Group SL, BAT Tower, Gran Via 1, 48001, Bilbao, Biscay, Spain, registered with the MHRA as AI LABS GROUP SL.
- Application reference: 2023031201298475
- Confirmation letter dated: 14 March 2023
- Manufacturer registration status: Registered
The MHRA registration confirmation letter states that it does not represent accreditation, certification or approval by the UK Competent Authority. Registration records the manufacturer and the device with the MHRA. It is not an assessment or an endorsement of the device.
UK Responsible Person
APOTECH CONSULTING LIMITED, 71-75 Shelton Street, London, WC2H 9JQ, England, United Kingdom.
Reporting a serious incident in the United Kingdom
Serious incidents involving devices placed on the UK market are reported to the MHRA under the UK Medical Devices Regulations 2002 (as amended).
Users and healthcare professionals in the United Kingdom can report an adverse incident involving a medical device to the MHRA through the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/.
The manufacturer reports serious incidents to the MHRA by email to devices.regulatory@mhra.gov.uk, within the following timelines.
| Type of serious incident | The manufacturer reports no later than |
|---|---|
| Serious public health threat | 2 calendar days |
| Death or serious deterioration in health | 10 calendar days |
| Other serious incidents | 15 calendar days |
The UK Responsible Person is informed of all serious incidents occurring in the United Kingdom.
Serious incidents should also be reported to the manufacturer at support@legit.health, as described in Important safety information.