MDCG 2020 Guidance on significant changes- Review, problems and tips

1
MDCG 2020-3 - Guidance on significant
changes
Review, problems and tips
Antonio Bartolozzi
antonio.bartolozzi@bartolozzi.it 18/06/2019

2antonio.bartolozzi@bartolozzi.it
MDCG 2020-3 March 2020
Guidance on significant changes regarding the transitional provision under
Article 120 of the MDR with regard to devices covered by certificates
according to MDD or AIMDD (1 MB)

Software
<omissis> ….. Chart C, which is specific to software,
draws inspiration from Annex VI, Part C,
section 6.5 of the MDR to identify
modifications that are considered as significant
change in (software) design.
Is it only an «inspiration» ?

MDR – VI – 6.5.2 - 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 CONFIRMED Significant design change

MDR VI - 6.5.3. Minor software revisions
6.5.3. Minor software revisions shall require a new UDI-PI and not a
new UDI-DI.
Minor software revisions are generally associated with bug fixes,
usability enhancements that are not for safety purposes, security
patches or operating efficiency.
Minor software revisions shall be identified by a manufacturer-specific
form of identification.
Not always !
WARNING : Minor software
revisions that are not
involved in safety

Main Chart
Change of an existing Medical Device
certified under MDD or AIMDD
Change of the
Intended
Purpose?
Software
change?
Chart A
Chart B
Chart C
Yes
Yes
Yes
No
No If non-
significant
If non-
significant
If non-
significant
A
C
Change of the
design or
performance
specification?
No
No
Design change
related to corrective
actions*?
*assessed and accepted by
the relevant Competent
Authority acc. to CAMD FAQ
no 17
Yes
X
B
4.5.2.b1 the intended use of the
software;
4.5.2.a the original performance
4.5.2.b2 Safety

A - 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?

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

Main Chart 2
Change of a
Material*?
Change
of terminal
sterilization method of
device or packaging design
with impact to the
sterilisation?
Chart D
Chart E
The change is considered a
non-significant change
per MDR Art. 120(3)
Yes
Yes
No
No
If non-
significant
No
D
E
*The term material
includes any substance
(synthetic, natural,
biological, chemical,
physical, medicinal,
...) that is used to make
or compose the device
It is not
software

Chart B
From Main Chart:
Change of the Design or Performance Specification*
Yes
No
B1
Yes
Change
of built-in control
mechanism, operating
principles, source
of energy or
alarms
?
No
Return toMain Chart
QuestionC (or move directly to E
if Chart D was previously used)
Yes
B3
The changeisconsidered
significantper MDR Art. 120(3)
* It shall not be taken into
account how the change is
achieved. A change in
specification may be triggered
by, but is not limited to,
change of hardware or
software, including change of
a component.Does the
change require
further clinicalor
usability data to support
safety and perfor-
mance?
**
Do new risks
require control measures
or are existingrisks
negatively affected?
No
B2
** Compare
MEDDEV 2.7/1
rev.4
For further guidance

(48) Clinical data
(48) ‘clinical data’ means information concerning safety or performance that
is generated from the use of a device and is sourced from the following:
— clinical investigation(s) of the device concerned,
— clinical investigation(s) or other studies reported in scientific literature, of a
device for which equivalence to the device in question can be demonstrated,
— reports published in peer reviewed scientific literature on other clinical
experience of either the device in question or a device for which equivalence
to the device in question can be demonstrated,
— clinically relevant information coming from post-market surveillance, in
particular the post-market clinical follow-up;

(63) Demostration of compliance
(63) To ensure a high level of safety and performance,
demonstration of compliance with the general safety and
performance requirements laid down in this Regulation
should be based on clinical data

B1 - change that require further clinical or
usability data to support safety and performance
general safety and
performance
requirements
compliance clinical datamodifydevice
change
Art.83.3 Data gathered by the
manufacturer's post-market
surveillance system shall in
particular be used: (f) for
the identification of options
to improve the usability,
Usability
ChangeUsability data Major change
Are further clinical data necessary to support safety of the altered device?

B2 - new risks require control measures
New control
measure
device
change Major changeNew risk
Do the results of a risk analysis,
undertaken during the design verification
and validation process, raise new issues of
safety?

B2 - existing risks negatively affected
Modify risk
existing risks
negatively
affected
Major change
device
change
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?

B3 – Change of built-in control mechanism
Change of Any system used to keep one
or more variable parameters constant,
or within specified bounds.
If SpO2 >= 100 then
raise exception (‘Oxigen saturation error’);
Error
CHANGE
If SpO2 > 100 then
raise exception (‘Oxigen saturation error’);
X
Major
change
IT IS NOT A BUG FIX
control mechanism

B3 – Change of operating principles
(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

Tips #1
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

Tips #2
Specify in your Technical
file/Documentation
Performance specifications tolerances
!

B3 – Change of alarms
introduction to or removal of a new alarm
function from the software such that a
response to the new configuration may
change the treatment of the patient in
comparison to the previous version of the
software;
NBOG 2014-3
Major
change
introduction to or removal of a new alarm
function from the software such that a
response to the new configuration may
change the device intended medical
purposes and performance in
comparison to the previous version of the
software;
MDR

Tips #3
Design very well your alarm system !
You cannot change it easily
unfortunately (luckily?).

Chart C Steps 1-2-3-4
Chart C
FromMain Chart:
Software Change
New or modified
architecture or database
structure, change of
an algorithm?
Yes
YesRequired
user input replaced
by closed loop
algorithm
?
New or major
change of operating
system or any
component?
Yes
C1
No
C2
No
C3
New diagnostic or
therapeutic feature,
or new channel of
inter-operability
?
Yes
C4
No
No

C1 New or major change of operating system or any
component
a software change that modifies the
software system (not software code) with
not negligible risk of impacting the device
intended medical purposes and
performance
New or major change
of operating system
or any component
Software Change Where is the
impact?
Major Change
New Operating system version Many API calls (used
by MD)
Yes
Operating system Patch1 No API calls NO
Operating system Patch2 Many API calls Yes
Application Server Patch1 Many API calls Yes

C2 New or modified architecture
New or modified
architecture
Major
Change
New Software Items,
New interfaces between
software items
1
3
2
1
3
2
4

C2 New or modified database structure
Change
table
New Table
New or modified database structure 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.
Impact
• Performance
• Safety
• Interpretation
Examples :
• Is the application too
slow?
• have you changed the
meaning of a column?

C2 change of an algorithm
an alteration in a software that modifies an algorithm
impacting the device intended medical purposes and
performance;
Algorithm for
drawing
physiological
parameters/
waveforms
Significant change
Algorithm for
printing all
the bills
Minor change

C3 Required user input replaced by closed loop
algorithm
See C2 change of an algorithm

C4 New diagnostic or therapeutic
feature
Major Change
Is it “an alteration in software impacting the device
intended medical purposes and performance” ?
YES
It means that it is outside the intended use
NO
Example (Minor) :
Add diagnostic information about eye disease in an ECG Reporting System
Example (Major) :
Add diagnostic information about R-R
interval in an ECG Reporting System

C4 New channel of interoperability
See C2 New or modified architecture

Chart Steps 5-6
Yes
No
Return to Main Chart
Question D
C5
No
New user
interface or
presentation
of data*
?
*“Presentation of data“
goes beyond the
appearance of the user-
interface which may
include new languages,
layouts or graphics and is
considered a minor
change. It is connected
to medical data which are
presented in a new
format or by a new
dimension or measuring
unit.
Yes
*Minor changes
without impact to
diagnosis or treatment
delivered may include:
- Correction of an
error which does
not pose a safety
risk (bug fixes),
- Security update (e.g.
cyber-security
enhancements,
longevity
calculations),
- appearanceof the user
interface,
- Operating effeciencies,
- Changes to enhance the
user interface without
changes in performance
Minor
Change*
?
C6
The change is considered
significant per MDR Art. 120(3)
Ispiration
…. bug fixes, usability
enhancements that are
not for safety purposes,
security patches or
operating efficiency.
Security update are
not only security
patch!
«(c) interpretation of data»
MDR

C5 New user interface or presentation of data
*“Presentation of data“ goes
beyond the appearance of the
user-interface which may
include new languages, layouts
or graphics and is considered a
minor change. ?
Are New languages for
a user interface a minor
or Major change ?
a software change that modifies the
appearance of the user interface/
presentation of data/interpretation of
data with not negligible risk of impacting
the device intended medical purposes
and performance
Major
Change
It is connected to medical data
which are presented in a new
format or by a new dimension or
measuring unit.
?
?
Both

C5 Major Change (Language)
Label.caption=‘Heart rate’; Label.caption=‘Battito cardiaco’;
Massive Source code change
Major Change
English Italian
“Presentation of data“ goes beyond
the appearance of the user-interface

C5 Minor Change (Language)
Label.caption=resource_manager.load(Heart_Rate, UserLanguage);
No Source code change
Minor Change
Source code
«resource management sw tool» validation
“Presentation of data“ goes beyond
the appearance of the user-interface

C5 – interpretation/presentation of data
NBOG 2014-3
(c) interpretation/presentation 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

C5 Example interpretation/presentation of data
CHANGE
Major
Change
Windows APP WEB APP

C6 Minor Change
Minor changes without impact to diagnosis or treatment
delivered may include:
- Correction of an error which does not pose a safety risk
(bug fixes),
- Security update (e.g. cyber-security enhancements,
longevity calculations),
- Appearance of the user interface,
- Changes to enhance the user interface without changes in
performance
What about other medical purposes ? Are they not included?
• prevention, monitoring, prediction, prognosis, alleviation of disease,
• monitoring, alleviation of, or compensation for, an injury or disability,
• investigation, replacement or modification of the anatomy or of a
physiological or pathological process or state,
• providing information by means of in vitro examination of
specimens derived from the human body, including organ, blood and
tissue donations,

C6 Example
A Security update with a strong impact to the prevention/prediction
(without impact to diagnosis or treatment delivered) of a heart
disease
Minor Change
?
?
?
?
?
?
Minor changes without impact to diagnosis
or treatment delivered may include:
- Correction of an error which does not pose
a safety risk (bug fixes),
- Security update (e.g. cyber-security
enhancements, longevity calculations),
- Changes to enhance the user interface
without changes in performance
5 %
Heart
disease
prediction
No healthy lifestyle
put patient's life at risk
Wrong prediction

C5 Minor Change - Updated
Minor changes with negligible risk of impacting the
device intended medical purposes and performance
may include:
- Correction of an error which does not pose a
safety risk (bug fixes),
- Changes to enhance the user interface without
changes in performance

C5 - WARING : Not Minor Change
- Correction of an error (bug fixes),
- Changes to enhance the user interface
Major Change !!!!
… with high risk of impacting the
device intended medical purposes
and performance

C5 Example (Major)
Major Change
A Security update with a strong impact to the
prevention/prediction of a stroke

Warning : Class I – MDCG 2020-3
In relation to class I medical devices requiring the involvement of a
notified body for the first time, manufacturers of such devices must be
able to justify their decision when the changes are considered to be non-
significant. The justification shall be documented and made available
when requested.
Please verify it during ISO 13485 Audit

Conclusion
• MDCG 2020-3 is a (little?) step in the right direction
• There aren’t any examples !
• There is a lack of security topics
• The old concept of «impacting the diagnosis or therapy
delivered to the patient» is still there (a more aligned way with the
MDR of saying it would be «impacting the medical purposes and
performance of the device»)
For any further clarification or question, please write me at
antonio.bartolozzi@bartolozzi.it

MDCG 2020 Guidance on significant changes- Review, problems and tips

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MDCG 2020 Guidance on significant changes- Review, problems and tips