Censura Health Checks is a comprehensive suite of software designed to manage the NHS Health Checks Programme

Contact us

Key Features

1.  Allow practices to record health checks easily with onboard QRISK calculation and writeback to patient records​​
   • ​​Use ARDENS^® list without any double entry by avoiding jumping out to the QRISK website (not a class1 medical device)
2. Allow Community users to work away from internet connections to record health checks in the workplace or from a remote location and writeback to patient clinical records
3. Allow Healthcare Organisations to commission management software that​

• Stratifies the population by QRISK score and/or many other factors including ethnicity and hard to reach groups
• Provides the practices with management tools that monitor and action the tasks required to meet the Health Checks Targets
• Provides comprehensive reporting for Healthcare Organisations including compliance reports to enable management of the entire health checks programme.
• Allows patients to complete a 'pre-health check questionnaire' to reduce the time taken to conduct a health check.

 

​

MHRA COMPLIANCE

Supplier	Product	MHRA Status	Compliance and UK Standards
TCR(Nottingham) Ltd	CENSURA HEALTH CHECKS For use by General Practice to record health checks and writeback to clinical records. For use by community organisations to capture workplace or opportunistic health checks and writeback to clinical records. For use by Healthcare organisations to manage the Health checks programme and ensure DCB0160 compliance. For use with EMIS Web And TPP SystmOne	CLASS 1 Medical Device Registered	Medical Devices Regulations 2002 (SI 2002 No 618 as amended) IEC 62304:2006/AMD 1:2015 BS EN ISO 14971:2019 PD IEC/TR 80002-1:2009 BS EN 1041:2008 BS EN ISO 15223-1:2016 ISO 27001: 2013 Classification Class1, Annex IX, 3.3, Rule 12 DCB 0129

 

1. The Core Legal Framework — UK Medical Devices Regulations 2002 (as amended)

Under UK law (post-Brexit retained version of the MDR 2002), any software that performs a medical purpose, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, is classed as a medical device.

The relevant enforcement authority is the MHRA (Medicines and Healthcare products Regulatory Agency).

Risk classification follows Annex IX / MDR Annex VIII principles, where standalone diagnostic or decision-support software that influences clinical decisions is typically Class IIa, but may be Class I if it performs simple calculations with transparent logic and no automated decision-making.

QRISK (as a cardiovascular risk calculator) clearly falls under this regime — it predicts the likelihood of future disease (cardiovascular event) — and thus it is a medical device under MDR, usually Class I (self-declared) or Class IIa depending on implementation.

2. Enforcement on Suppliers — MHRA & DCB0129

Suppliers who provide QRISK implementations (e.g., embedded in EMIS Web, SystmOne, or standalone apps) are required to:

- Register their software as a medical device with the MHRA (Class I if self-certified, or with a notified body if higher class).

- Maintain a Clinical Safety Management System and Safety Case (DCB0129).

- Label the product with a UKCA mark (or CE mark during transition).

Failure to do this is a breach of UK medical device law and can lead to MHRA enforcement.

3. Enforcement on Public Health Bodies / NHS Organisations — DCB0160 & NHS Contract

Public health bodies (e.g. NHS England, ICBs, or local authorities commissioning public health services) are not device manufacturers — but they are legally accountable for ensuring that any system they deploy complies with the law.

This obligation is enforced through:

a. DCB0160 (Clinical Risk Management in Deployment and Use)

Clause 6 explicitly requires NHS organisations to verify that all deployed systems are DCB0129-compliant and conform with relevant regulations (including MHRA device registration where applicable).

The organisation’s Clinical Safety Officer (CSO) must confirm supplier registration and device class as part of their safety case acceptance.

b. NHS Standard Contract (Service Condition 42 – Clinical Risk Management)

States that suppliers of IT systems used for patient care must be compliant with DCB0129 and registered as medical devices if applicable.

Providers (Trusts, ICBs, or public health bodies) must not deploy or use such systems unless they have verified these requirements under DCB0160.

c. DTAC (Digital Technology Assessment Criteria for health and social care)

In the Clinical Safety section, suppliers must provide:

- The MHRA registration number and device class (e.g., “Class I – MHRA registered software as a medical device”).

- The DCB0129 Clinical Safety Case Report and Hazard Log.

Deploying organisations must review these artefacts under DCB0160 before approval.

4. Enforcement Mechanism in Practice

Enforcement Layer	Applies To	What It Requires	Enforced By
MHRA MDR 2002	Supplier / Manufacturer	Device registration, classification, UKCA marking	MHRA
DCB0129	Supplier	Clinical safety management during development	NHS England (assurance) / Customer requirement
DCB0160	Public Health Body / NHS Org	Verify DCB0129 and MHRA compliance before deployment	NHS England / Commissioners
NHS Standard Contract	NHS Providers	Mandatory compliance with both standards	Commissioners / NHS England
DTAC	Suppliers and Commissioners	Declaration of MHRA status and safety documentation	NHS England Transformation Directorate

5. In Summary

Public health bodies are required to ensure that suppliers providing QRISK (or similar predictive algorithms) are registered as Class I medical devices under the UK Medical Devices Regulations.

This duty is enforced through:

- DCB0160 (clinical safety assurance by the deploying body)

- NHS Standard Contract (Service Condition 42)

- DTAC compliance checks

- MHRA oversight of device registration and claims.

The qrisk.org website DOES NOT DISPLAY A CA MARK and states that 

"This demonstrator is intended for reference purposes only, and as a guide.

Note that this web site is not a class 1 medical device, and therefore is not intended for clinical use.

For health professionals using clinical management systems, we recommend the use of the EP-QRISK3 Engine integrated with a health management system.

Unlike this web site, the EP-QRISK3 Engine is registered as a Class I medical device which is a prerequisite for the use of decision support software for patient care, and is available in a variety of forms for system suppliers to use."