Clinical Safety






Overarching Standard



Effective Date

Apr 11, 2023




Supports the management of clinical risk and Patient safety.

Clinical Safety is a mandatory overarching Standard. IT is an integral part of modern healthcare, and the functionality it provides is becoming more and more sophisticated. However, it must be recognised that IT failure, or incorrect use has the potential to cause harm to those Patients that it is intended to benefit. Clinical Safety ensures that effective clinical risk management is carried out by organisations that are responsible for developing and modifying IT Solutions, and purchasers are involved in the clinical risk management process.

The term ‘clinical risk’ is used to emphasise that the scope is limited to the management of risks related to Patient safety, as distinct from other types of risk such as financial. Clinical risk management may be conducted within the context of an overall risk management system operated by the Supplier and any wider health Information Governance processes. Wherever practical, existing risk management processes would be adapted, and used, to address the requirements for Clinical Safety.

This is not intended to be an exhaustive list of relevant regulations and Standards and it is the responsibility of the Supplier to identify and comply with any that are not included here.

Please note that compliance with the Clinical Safety Standard requires Suppliers to have a Clinical Safety Officer (CSO) in place. Any Suppliers who don't currently have a CSO in place, will not be awarded compliance with this Standard until this has been addressed.


Applicable Framework(s)

Requirement ID

Requirement Text


Applicable Framework(s)

Requirement ID

Requirement Text




Compliance with Clinical Risk Management: Its Application in the Manufacture of Health IT Systems

The Supplier shall be required to be compliant with the following Standard in respect of Clinical Safety:

The submitted safety documents shall be fit for purpose to enable the deploying organisations to undertake an informed risk assessment in line with the requirements specified in the following Standard:




MHRA Compliance

The Supplier shall consider whether their Solution falls under the MD regulation using the relevant UK MDR 2002 guidance and declare whether the Solution is classed as a Medical Device within the CSCR. For information see the MHRA website.

Note: This is only for information and completeness purposes and the Clinical Safety Group will not undertake any assessment against compliance with MHRA MD Standards.



Applicable Capabilities

All Suppliers Solutions delivering any Capabilities will need to meet this Standard.


Items on the Roadmap which impact or relate to this Standard

Suppliers will not be assessed or assured on these Roadmap Items as part of Onboarding