This document discusses clinical validation and regulation of artificial intelligence in the EU. It covers why regulation is needed for safety, transparency and quality. Medical device software must meet regulatory requirements if used for clinical purposes. The risk class determines the regulatory route for CE marking. Common standards like ISO 13485 cover quality management systems, while clinical evaluation reports summarize relevant clinical data and conclusions. Academic institutions producing medical software may need to comply with quality standards to legally deploy or market their products. Both benefits and challenges of the current regulatory framework are discussed.

1. Clinical validation and
regulation of AI
DR HUGH HARVEY - MANAGING DIRECTOR - HARDIAN HEALTH

2. Safety
Transparency
Quality
Clinical Evidence
Why regulate?

3. 3
In order to sell AI for a clinical
setting (in the EU) you need….

4. 4
Regulatory Infrastructure
EU Governance UK Governance Notified Bodies Vendors

5. Medical Device Software (MDSW)
Medical device software is software that is intended to be used, alone or in
combination, for a purpose as specified in the definition of a “medical device” in
the medical devices regulation or in vitro diagnostic medical devices regulation.
5

6. Is your software a medical
device?
Is the software an
MDR Annex XVI
device, an accessory
for a medical device,
or does it ‘drive or
influence’ the use of a
hardware medical
device?
Does it perform an
action on data
beyond storage,
archival,
communication,
simple search, or
lossless
compression
Does it benefit
individual patients?
A medical device
Not a medical device
NO NO
NO
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7. 7
Risk Class
Not all devices are in the
same risk class
Risk class defines which
route to take for CE
marking
Moderate Risk
2
High Risk
3
Low Risk
1
SaMD

8. 8

9. 9
Risk Class

10. 10
IIb or not IIb?

11. 11

12. 12
Common ISO and IEC standards
Quality
Management
Systems
13485 27001
Security
Management
62304
Software
lifecycle
process
14971
Risk
Management

13. 13
ISO : 13485
Product Lifecycle
Documentation
Clinical
Evaluation
Report
Quality and
Safety
Documentation
UDI and
GSPR
PMS and
PSUR

14. What does a QMS look like?
14

15. What does a QMS look like?
15

16. What does a QMS look like?
16

17. What does a Risk Assessment look
like?
17

18. What does a Risk Assessment look
like?
18

19. 19

20. • A description of the technical aspects of the device, including design and composition
• Review of intended therapeutic or application claims
• Clinical evaluation protocol and data inputs and parameters
• Summary of relevant clinical data and findings
• Description of the analyses used in the clinical evaluation assessment
• Strong conclusion regarding safety, performance and conformity, linking the results of
the clinical evaluation to specific, relevant ERs
• Data used in the analyses should be appended to the CER
• Content should be accurately referenced
• CVs of the authors should be included and it should be signed by the Author(s) and Reviewers
Clinical Evaluation Report (CER)
20

21. Mandatory to perform a clinical investigation if:
● Class III device
● Class II device based on innovative technologies
● Class II device with a new intended use (no equivalent device on market)
Do we need to do a clinical investigation?
21

22. In review: Proposed Evaluation and Approval Process to Ensure the Safe and
Effective Deployment of Diagnostic Algorithms in Medical Imaging - Langlotz,
Larson, Harvey
22

23. EUDAMED will be a database forum for manufacturers,
distributors, authorized representatives, competent authorities
and the European Commission to exchange information about
medical devices.
Information such as product registration, declaration of
conformity, economic operators, vigilance reports and post-
market surveillance.
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25. 25

26. 26
Academics are not exempt from
regulation!
AI vendor
or
OEM
Academic
Or
Hospital
QMS ISO:13485
“Put into Use”
“Place on
Market”

27. 27
Pros and Cons
Pros
● Better transparency (EUDAMED)
● Increased focus on safety and follow up
● Globally standardised methodologies
Cons
● Clinical evaluation not transparent for all
classes
● Prospective studies not required
● Lack of guidance on ‘validation data’ quality

28. 28
Talking Points
● Should ALL clinical evaluations of medical devices be peer reviewed?
○ Yes - for transparency and trust
○ No - often not adding to scientific literature (unpublishable), intellectual property
issues
● Should ALL academic institutions that produce software become ISO:13485
compliant?
○ Yes - fosters innovation, drives impact, speeds time to market for spin-outs
○ No - may slow research phase, not interested in delivering utility to front line

29. Thanks
hugh@hardianhealth.com
@drhughharvey