MHRA safety guidance. Medical device stand-alone software including apps (including IVDMDs)

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MHRA has made further updates to the attached guidance document which was last circulated in Scotland by IRIC in September 2022. This updated version applies across the UK. Within Scotland it applies to NHS Boards, local authorities and any contractors providing publicly funded health and social care services. 

The guidance can be accessed here and the changes which are on P1, P11, P30 & P34 are summarised as follows:

Update on implementation, links to new Intended purpose guidance, software vigilance guidance and link to new MORE page:

• P1 – https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
• P11 – https://www.gov.uk/government/publications/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd
• P30 & P34 https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system
• P30 & P34 https://more.mhra.gov.uk/login

Note that the document is intended to be viewed on screen rather than printed. It can be quickly navigated using links rather than protracted scrolling and at the bottom of each page you will find a navigation pane with quick links to the start

of the main sections. Links are also provided for information on the UKCA marking process. You can also view the guidance on the web by visiting the MHRA website.

Onward cascade
As the nominated person for your organisation, you need to identify managers and staff in your organisation who need to know or be aware of this document and cascade it onward to them. The cascade should include all contractors and private or independent service providers who provide affected care, staff, equipment, buildings or other services or facilities for the direct care of patients or service users. In the meantime, our suggested onward cascade is as follows:

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:

• Medical devices (e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator)
• In vitro diagnostic devices or IVDs (e.g. blood analyser, reagent, SARS-CoV-2 test kit)
• Estates and facilities (e.g. electrical installations, window restrictors, nurse call systems)
• Social care equipment (e.g. mobile wheeled commode, powered rise and recline chair)
• Personal protective equipment or PPE (e.g. visors, FFP3 respirators, aprons)

We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/  

Enquiries
If you have any enquiries in relation to this document please email nss.iric@nhs.scot quoting the alert reference number in the message subject line, or call the IRIC Helpline 0131 275 7575. Alternatively, if you have received this message from someone in your own organisation, please direct all enquiries to them and they will liaise with IRIC as required.

Incident Reporting & Investigation Centre (IRIC)

Health Facilities Scotland

NHS National Services Scotland

Contact us:

IRIC Email         nss.iric@nhs.scot

Helpline             0131 275 7575

Web                 https://www.nss.nhs.scot/browse/health-facilities/incidents-and-alerts

Please consider the environment before printing this email.

NHS National Services Scotland is the common name for the Common Services Agency for the Scottish Health Service. www.nhsnss.org

FAC406-272, 8B(ii), Rev 3