Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

I work for a company that produces standalone software used in clinical laboratories. Some are considered medical devices (they have CE mark for example), some are not.
I just became aware of the UK standard DCB0129 "Clinical Risk Management".
Do you know if a manufacturer who want to sell their software in a UK hospital has to comply with this standard? If so, is this standard also mandatory for software that are not considered medical devices in the UK?

Thanks for your help!

Hello Anon,

I have been aware of these specifications from back in 2015 when I stumbled across them - there are a few related around clinical software use.  This is something internal to the NHS for their purposes, but I could definitely see how this would apply for software medical devices used in the UK.  Personally I am not aware of how mandatory these are or how expectations are being fed down to manufacturers.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 25-May-2021 11:29
From: Anonymous Member
Subject: UK standard DCB0129 "Clinical Risk Management" for software

This message was posted by a user wishing to remain anonymous

Hi all,

I work for a company that produces standalone software used in clinical laboratories. Some are considered medical devices (they have CE mark for example), some are not.
I just became aware of the UK standard DCB0129 "Clinical Risk Management".
Do you know if a manufacturer who want to sell their software in a UK hospital has to comply with this standard? If so, is this standard also mandatory for software that are not considered medical devices in the UK?

Thanks for your help!

On the NHS Digital website I read; "Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012."

https://digital.nhs.uk/services/clinical-safety/clinical-risk-management-standards

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Kevin Painter
Mentor, Medical Device Regulatory Compliance
Poland and United Kingdom
------------------------------

Original Message:
Sent: 25-May-2021 11:29
From: Anonymous Member
Subject: UK standard DCB0129 "Clinical Risk Management" for software

This message was posted by a user wishing to remain anonymous

Hi all,

I work for a company that produces standalone software used in clinical laboratories. Some are considered medical devices (they have CE mark for example), some are not.
I just became aware of the UK standard DCB0129 "Clinical Risk Management".
Do you know if a manufacturer who want to sell their software in a UK hospital has to comply with this standard? If so, is this standard also mandatory for software that are not considered medical devices in the UK?

Thanks for your help!

Hello,

They will usually be required and mentioned in NHS contracts and software manufacturers expected to comply and give evidence of compliance on request.

It's not that much more than ISO 14971:2019, apart from the specific tasks around the clinical risk manager and some terminology differences that can be explained if required.

David

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David Clafton
Mirada Medical
Oxford
United Kingdom
------------------------------

Original Message:
Sent: 25-May-2021 11:29
From: Anonymous Member
Subject: UK standard DCB0129 "Clinical Risk Management" for software

This message was posted by a user wishing to remain anonymous

Hi all,

I work for a company that produces standalone software used in clinical laboratories. Some are considered medical devices (they have CE mark for example), some are not.
I just became aware of the UK standard DCB0129 "Clinical Risk Management".
Do you know if a manufacturer who want to sell their software in a UK hospital has to comply with this standard? If so, is this standard also mandatory for software that are not considered medical devices in the UK?

Thanks for your help!