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
6
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
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.
23
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
