MDR - Significant changes in the design and intended purpose – Software changes,Problems & Tips

1. 1
MDR - Significant changes in the design and
intended purpose – Software changes,
Problems & Tips
Antonio Bartolozzi
antonio.bartolozzi@bartolozzi.it 18/06/2019
Feature Value Tollerance Giustification
Max GUI
Response Time
< 9s
Seconds
± 1s See Robert B Miller
1968; Card et al. 1991
Password
lenght
(security)
> 15char. 0 See guideline
SecurityU12.doc
Boot time < 20s ± 1s Intended Env. : no
intensive care rooms

2. 2antonio.bartolozzi@bartolozzi.it
Class I and significant changes
Art120.3 By way of derogation from Article 5 of this Regulation, a device
which is a class I device pursuant to Directive 93/42/EEC, for which the
declaration of conformity was drawn up prior to 26 May 2020 and for which
the conformity assessment procedure pursuant to this Regulation requires
the involvement of a notified body, or which has a certificate that was issued
in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is
valid by virtue of paragraph 2 of this Article, may be placed on the market or
put into service until 26 May 2024, provided that from 26 May 2020 it
continues to comply with either of those Directives, and provided there are
no significant changes in the design and intended purpose. However, the
requirements of this Regulation relating to post-market surveillance, market
surveillance, vigilance, registration of economic operators and of devices
shall apply in place of the corresponding requirements in those Directives.

3. 3antonio.bartolozzi@bartolozzi.it
NBOG GuideLine - MDD
NBOG’s Best Practice Guide 2014-3
Guidance for manufacturers and Notified Bodies on
reporting of Design Changes and Changes of the
Quality System
Is it applicable to the MDR ?
Short Answer : Yes (with discernment )

4. 4antonio.bartolozzi@bartolozzi.it
MDR – UDI - software changes
ANNEX VI
6.5.2. A new UDI-DI shall be required whenever there is a modification
that changes:
(a) the original performance;
(b) the safety or the intended use of the software;
(c) interpretation of data.
Such modifications include new or modified algorithms, database structures,
operating platform, architecture or new user interfaces or new channels for
interoperability.
New UDI Required Significant design change

5. 5antonio.bartolozzi@bartolozzi.it
Problem #1
Where is the security ?
Please consider security like a
performance issue

6. 6antonio.bartolozzi@bartolozzi.it
Software significant change-performance
(a) the original performance
NBOG 2014-3
1. Does the design change affect the indications or contraindications for use or
warnings necessary to ensure performance for the intended use of the device?
2. Are further clinical data necessary to support performance of the altered device?
3. Do the results of a risk analysis, undertaken during the design verification and
validation process, raise new issues of performance?
4. Does the change affect the performance of the medical device?
In cases where the change consists only of tightening of design specifications within
specified tolerances and where there is no creation of new features, the change is
not considered to be substantial

7. 7antonio.bartolozzi@bartolozzi.it
Tips #1
Specify in your Technical
file/Documentation
Performance specifications tolerances
!

8. 8antonio.bartolozzi@bartolozzi.it
Examples
Feature Value Tollerance Giustification
Max GUI
Response Time
< 9 Seconds ± 1s See Robert B Miller 1968;
Card et al. 1991
Password lenght
(security)
> 15
characters
0 See guideline XXXX
Boot time < 20 seconds ± 1s Intended Env. : no intensive
care rooms

9. 9antonio.bartolozzi@bartolozzi.it
Software significant change - Safety
NBOG 2014-3
1. Does the design change affect the indications or contraindications for use or
warnings necessary to ensure safety for the intended use of the device?
2. Are further clinical data necessary to support safety of the altered device?
3. Do the results of a risk analysis, undertaken during the design verification and
validation process, raise new issues of safety?
4. Does the change affect the safety of the medical device?
In cases where the change consists only of tightening of design specifications within
specified tolerances and where there is no creation of new features, the change is
not considered to be substantial
(b1) the safety of the
software;

10. 10antonio.bartolozzi@bartolozzi.it
Tips #2
Specify in your Technical
file/documentation
Safety specifications tolerances !

11. 11antonio.bartolozzi@bartolozzi.it
Examples
Feature Value Tollerance Giustification
Alarm responce
time
< 2 Seconds ± 0.5s No damage for brain
Max Risk Index 100 0 Confirmed with clinical
evaluation (cap. XX
ClinicEval.doc)

12. 12antonio.bartolozzi@bartolozzi.it
Software significant change – Intended use
NBOG 2014-3
(b1) the intended use of the
software;
• Changes of the intended purpose
• Are new hazards introduced which have not previously been addressed?
• Does the change alter the details on intended use given in the design/type approval
dossier submitted to the Notified Body?
• Does the change trigger a need to alter the indications or contraindications for use or
warnings necessary to ensure safety and efficacy for the intended use of the device?
• Does the change mean that the device will have different end users or be used in a
different manner?
• Does the change mean that the clinical data/performance evaluation data for the original
device is not sufficient to assure conformity of the changed device with the required
characteristics and performance?

13. 13antonio.bartolozzi@bartolozzi.it
Tips #3
Write the intended use very well

14. 14antonio.bartolozzi@bartolozzi.it
Example
The Vista System is intended for use in facilities that are automating the process
associated with managing donor information, including information about blood
collection and manufacture of blood components, with the following functions:
• Managing donor data such as blood loss history , donor vital signs relevant to
blood collection, and demographics
• Storing and reporting device-connected and manually entered collection procedure
information
• Determining donor eligibility by considering donor blood loss history , user-
configured eligibility parameters, and immediate safety qualifications
• Interfacing with the Trima® Accel Automated Blood Collection System
• Aiding in the management of these blood establishment processes:
- Trima Accel sy tem configuration management
- Periodic review of platelet count and other indicators of donor health
- Prioritization and management of blood component collection
• Exchanging data with blood establishment computer systems (BECS)
• Collecting and managing data associated with whole blood and apheresis
collection procedure

15. 15antonio.bartolozzi@bartolozzi.it
Example
Intende Use Clinical Evaluation Risks/Benefits Predicate device
managing donor
information, including
information about
blood collection and
manufacture of blood
components
ClinicalEval.doc
Cap.2
RiskAnalysis.doc
Risk 2.1
Benefit 3.1
Vista Information
System, Version 4.0
Managing donor data
such as blood loss
history , donor vital
signs relevant to
blood collection, and
demographics
ClinicalEval.doc
Cap.2
RiskAnalysis.doc
Risk 3.3 3.4 3.5
Benefit 7.1 7.2
Vista Information
System, Version 4.0

16. 16antonio.bartolozzi@bartolozzi.it
Software significant change – interpretation
NBOG 2014-3
(c) interpretation of data
a software change that impacts the way data is read or interpreted by the user, such
that the treatment or diagnosis of the patient may be altered when compared to the
previous version of the software;
a software change that impacts the way data is read or interpreted by the user, such
that the device intended medical purposes and performance may be altered when
compared to the previous version of the software;
MDR

17. 17antonio.bartolozzi@bartolozzi.it
Software significant change – interpretation
a software change that impacts the way data is read or interpreted by the user, such
that the device intended medical purposes and performance may be altered when
compared to the previous version of the software;
You must review the risk analysis/design documents after each software
change that impacts the way data is read or interpreted by the user
Review Safety and performance (see slide #8,#11,#15)
Tips #4
a change that impacts the way data is read or interpreted by the user with not
negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.

18. 18antonio.bartolozzi@bartolozzi.it
Software significant change – Modifications
Such modifications include new or modified
algorithms, database structures, operating platform,
architecture or new user interfaces or new channels
for interoperability.
NBOG 2014-3
• an alteration in software that modifies an algorithm impacting the diagnosis or the therapy delivered;
• a software change that incorporates a significant change to the operating system on which the software runs.
• a software change that modifies the appearance of the user interface with not negligible risk of impacting the
diagnosis or therapy delivered to the patient
• No indication about the database structure
Better one
• an alteration in software that modifies an algorithm impacting the device intended medical
purposes and performance;
• a software change that incorporates a significant change to the operating system on which
the software runs with not negligible risk of impacting the device intended medical
purposes and performance.
• a software change that modifies the appearance of the user interface with not negligible
risk of impacting the device intended medical purposes and performance
• No indication about the database structure ➔ Problem #2

19. 19antonio.bartolozzi@bartolozzi.it
Software significant change – Algorithm
an alteration in software that modifies an algorithm impacting
the device intended medical purposes and performance;
a software change that modifies an algorithm with not negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
You must review the risk analysis/design documents
after each software change that modifies an algorithm
Review Safety,performance and intende use (see
slide #8,#11,#15)
Tips #5

20. 20antonio.bartolozzi@bartolozzi.it
Software significant change – OS
a software change that incorporates a significant change to the
operating system on which the software runs with not negligible
risk of impacting the device intended medical purposes and
performance
a change to the operating system (on which the medical device
software runs) with not negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
WARNING : A
minor change
in OS could
have a
significant
impact on the
safe of MD !!!
You must review the risk analysis/design documents after each
change to the OS
Review Safety,performance and intende use (see slide #8,#11,#15)
Tips #6

21. 21antonio.bartolozzi@bartolozzi.it
Software significant change – UI
a software change that modifies the appearance of the user interface with not
negligible risk of impacting the device intended medical purposes and
performance
a software change that modifies the appearance of the user interface with not
negligible risk of impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
Tips #7
You must review the risk analysis/design documents
after each change to the UI
Review Safety and performance (see slide
#8,#11,#15)

22. 22antonio.bartolozzi@bartolozzi.it
Software significant change – Database
… Such modifications include new or modified database structures
a software change that modifies the database structures with not negligible risk of
impacting :
a) the original performance;
b) the safety or the intended use of the software;
c) interpretation of data.
Tips #8
You must review the risk analysis/design documents
after each change to the database
Review Safety,performance and intende use (see
slide #8,#11,#15)

23. 23antonio.bartolozzi@bartolozzi.it
Are there Minor (not significant) changes?
Example : new non-medical features
Segregated software architecture
Segregated clinical software item
new non-medical features in
“non-clinical” software item Not significant
software change
Tips #9
a software change with negligible
risk of impacting :
a) the original performance;
b) the safety;

24. 24antonio.bartolozzi@bartolozzi.it
Are there Minor (not significant) changes?
Example : new non-medical features
Not Segregated software architecture
MDR
new non-medical features
a software change with not negligible
risk of impacting :
a) the original performance;
b) the safety;
there is a modification that changes:
(a) the original performance;
(b) the safety
Significant changes

25. 25antonio.bartolozzi@bartolozzi.it
WARNING : Divide et Impera
Segregation is at first a risk
mitigation action based on software
architecture.
Software Items can detect and correct each error “near
their origin”, instead of letting it propagate through the
whole application !
Without software segregation you must review all technical
documentation after any minor software change !!!!!!!!!!!!
Problem #3

26. 26antonio.bartolozzi@bartolozzi.it
Conclusion
NBOG’s Best Practice Guide 2014-3 is it a good guide also for MDR
(with discernment).
Please consider adding/changing the following topics :
• Security
• Database structure changes
• OS changes
• The MDD concept «impacting the diagnosis or therapy
delivered to the patient» is too limited (a more aligned way with
the MDR of saying it would be «impacting the medical purposes
and performance of the device»)
Please, review the risk analysis/design documents after each significant
change to the software
Review Safety, performance and intende use (see slide #8,#11,#15)

27. 27antonio.bartolozzi@bartolozzi.it
Conclusion - Warning
Without software
segregation all core
software changes
are nearly always
significant!
Please, design it …. Design it …. And again design it
Final Tips
For any further clarification or question, please write me at
antonio.bartolozzi@bartolozzi.it