Mdcg 2019 11 guidance on qualification and classification of software mdr-ivdr

Mdcg 2019 11 guidance on qualification and classification of software MDR and IVDR. Mistakers (and horrors)

1. 1
FINALLY PUBLISHED Guidance on Classification for Software
in MDR 2017/745 and IVDR 2017/746 MDCG 2019-11
Mistakes(and horrors) ☺
Antonio Bartolozzi
[email protected] 18/06/2019
State of
Healthcare
situation or
condition
Significance of information provided by SaMDto
healthcare decision
Treator
diagnose
Drive clinical
management
Informclinical
management
Critical III/IIbIII/IIbIII/IIb
Serious IIa IIa IIa
Non-seriousIIa IIa IIa

2. [email protected]
MDCG 2019-11 -Document
https://ec.europa.eu/docsroom/documents/37581?locale=en
Guidance on Classification for
Software in MDR 2017/745 and
IVDR 2017/746 MDCG 2019-11

3. [email protected]
WARNING –MDCG 2019-11
The document is not a European Commission document and it cannot
be regarded as reflecting the official position of the European
Commission. Any views expressed in this document are not legally
binding and only the Court of Justice of the European Union can give
binding interpretations of Union law

4. [email protected]
Software –MDCG 2019-11
For the purpose of this guidance,
“software” is defined as a set of
instructions that processes input
data and creates output data.
•Itisnota standard definition
•The definitiondoesnotdefinea product!!!
•Classification and Qualificationprocessisonlyfor
products !!!!

5. [email protected]
Software -ISO/IEC/IEEE26512:2018
3.22
software
all or part of the programs, procedures, rules, and associated documentation of
an information processing system
Note 1 to entry: For the purposes of this document, the term “software” does
not include on-screen documentation.
[SOURCE: IEEE Std 828-2012]
A product include documentationand labeling!

6. [email protected]
ISO 12207 : 2017 3.1.54 software product
3.1.54 software product
set of computer programs, procedures, and possibly
associated documentation and data
Note 1 to entry: A software product is a software system
viewed as the output (product) resulting from a process.

7. [email protected]
Software -ISO/IEC 2382:2015
software
<fundamental terms> all or part of the programs, procedures, rules, and associated
documentationof an information processing system
Note 1 to entry: Software is an intellectual creation that is independent of the medium
on which it is recorded.
Note 2 to entry: software: term and definition standardized by ISO/IEC [ISO/IEC
2382-1:1993].
Note 3 to entry: 01.01.08 (2382)
[SOURCE: ISO-IEC-2382-1 * 1993 * * * ]

8. [email protected]
MDSW –MDCG 2019-11
MedicalDeviceSoftware(MDSW)
Medicaldevicesoftwareissoftwarethatisintendedtobeused,aloneorin
combination,forapurposeasspecifiedinthedefinitionofa“medicaldevice”
inthemedicaldevicesregulation
15
orinvitrodiagnosticmedicaldevices
regulation.
16
Thisisnotaproduct ! -> software isdefinedas
a set of instructions that processes input data
and creates output data SO it could be any part
of a computer program
•Do notdefinea product !
•I cannotapplythe MDR to the MDSW!!!

9. [email protected]
3.12 MEDICALDEVICESOFTWARE EN 62304
software system that has been developed for the purpose of
being incorporated into the medical device being developed or
that is intended for use as a medical device
NOTE This includes a medical device software product, which
then is a medical device in its own right
•Samename !
•Differentdefintions!
•Overlappedpurposes!
•Thisisa rightdefintion!
•itisappropriate onlyfor the
purposesof the EN 62304 (not
for qualificationand
classificationpurposes)
ItisNOTaproduct
Product

10. [email protected]
ISO 12207 : 2017 3.1.55 software system
3.1.55
software system
system for which software is of primary importance to the stakeholders
Note 1 : In the most general case, a software system is comprised
of hardware, software, people, and manual procedures.
Note 2 : In a software system, software is the leading driver in meeting
system requirements.

11. [email protected]
Software as a Medical Device -IMDRF
SaMDis defined as software intended to be used for
one or more medical purposes that perform these
purposes without being part of a hardware medical
device.
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-
140918-samd-framework-risk-categorization-
141013.pdf#search=%22Framework%20for%20Risk%20Catego
rization%20and%20Corresponding%20%22
NOT software Embedded in hardware MD
SAMD ISA PRODUCT!
I can use thisdefinitionfor qualificationprocess
Thisisappropriate for a classifcationand qualificationguideline!

12. [email protected]
Istherea Legal base for usingIMDRF Guide (with MDR)?
(5) To the extent possible, guidance developed for medical devices at
international level, in particular in the context of the Global Harmonization
Task Force (GHTF) and its follow-up initiative, the International Medical
Devices Regulators Forum (IMDRF), should be taken into account to
promote the global convergence of regulationswhich contributes to a
high level of safety protection worldwide, and to facilitate trade, in
particular in the provisions on Unique Device Identification, general
safety and performance requirements, technical documentation,
classification rules, conformity assessment procedures and clinical
investigations
Legal base
Wecan use IMDRF definitionsin a qualificationand classificationguideline!
… So whynotuse it?

13. [email protected]
QualificationMDCG 2019-11
However, softwarewhich is intended to process, analyse, create or modify medical
information may be qualified as a medical device software if the creation or modification
of that information is governed by a medical intended purpose. For example, the software
which alters the representation of data for a medical purpose would qualify as a medical
device software.
Youcan qualifyonlyproducts ! Are theytalkingaboutstandalone software ?
Softwarecandirectlycontrola(hardware)medicaldevice(e.g.radiotherapy
treatmentsoftware),canprovideimmediatedecision-triggeringinformation
(e.g.bloodglucosemetersoftware),orcanprovidesupportforhealthcare
professionals(e.g.ECGinterpretationsoftware).
Thissoftware are part of the medicaldevices are notproduct ! And for sure
are notstand-alone software!

14. [email protected]
Decision steps for qualification of software as MDSW
Thereisno definitionof a
product ‘Software’ in the
guideline.
IsthisSoftware or product
‘software’ or software
includedin the product ?
MDR Covers only
products !!!
Software and MDSW are not
products !!!
WhataboutRule 11 ?

15. [email protected]
MDR rule 3.3 of Annex VIII
Software, which drives a device or influences the use of a device, shall
fall within the same class as the device.
If the software is independent of any other device, it shall be classified in
its own right.
Thismeansthata externalsoftware product thatdrives a
MD or influencesa MD hasthe sameclass.
Software product that
drives a infusionpump
Software hasthe same
class of the infusion
pump

16. [email protected]
MDR rule 3.5 of Annex VIII
3.5. If several rules, or if, within the same rule, several
sub-rules, apply to the same device based on the device's
intended purpose, the strictest rule and sub-rule resulting
in the higher classification shall apply.

17. [email protected]
MDR rule 3.5 -Example -MDCG 2019-11
Melanomaimageanalysissoftwareintendedtobeusedwithanear-infraredlaserlight
scanner,whichisconsideredclassIIaperRule10.Thesoftware“drivesor
influencestheuseof”thenear-infraredlaserlightscannerasitisintendedtotake
controlofthescannerbylettingitexecuteproprietarymulti-exposureprogramsfor
thedetectionofmelanoma.Assuch,implementingrule3.3applies.However,Rule
11wouldalsoapplybasedontheintendedmedicalpurposeofthesoftware
e.g.cancerdiagnosis.TheMDSWwouldbeclassifiedasclassIIIbasedonRule11
(seesectionClassificationRules)andperimplementingrule3.5ofAnnexVIII.
Istherea unacceptable RISK -of death or an
irreversible deterioration of a person's state of health
-after consideration of RISK CONTROL measures
external to the SOFTWARE SYSTEM?
NO
Thereare a numberof RISK
CONTROL measuresbeforea
death or an irreversible
deterioration of a person's state
of health(e.g. patient visit by
the physician).
Istherea unacceptable RISK -of a serious
deteriorationof a person's state of health -after
consideration of RISK CONTROL measures external to
the SOFTWARE SYSTEM ?
YESClass IIb

18. [email protected]
c.1.) Electronic Patient Record Systems(EPR)-MDCG 2019-11
Electronic patient record systems are intended to store and transfer electronic patient
records. They archive all kinds of documents and data related to a specific patient. The
electronic patient records should not be qualified as a medical device, i.e. an electronic
patient record that simply replaces a patient’s paper file does not meet the definition of
a medical device.
WhataboutRule 11 ?
Sub-rule11a),statesthatMDSW(whichisintendedtoprovideinformationwhichis
usedtotakedecisionswithdiagnosisortherapeuticpurposes)isclassifiedasclassIIa.
(Pag134.2ClassificationRulesMDCG2019-11)
EPR are intended to provide information which is used to take decisions
with diagnosis or therapeutic purposes! E.g. Vital parameters (SpO2,
NIBP, IBP, HR, etc.) are stored and shown by EPR
CLASS IIa

19. [email protected]
c.1.1.) CIS / Patient Data Management Systems –PDMS –MDCG 2019-11
A CIS/PDMS is a software-based system primarily intended to store and transfer
patient information generated in association with the patient’s intensive care
treatment (e.g. intensive care units).
Usually the system contains information such as patient identification, vital
intensive care parameters and other documented clinical observations.
These CIS/PDMS are not qualified as medical devices.
PDMS intended use is to
automatically document vital
parameters sampled by monitors
and to replace handwritten medical
files for clinical use.
Clinical Benefits of PDMS* Yes(%)No(%)Undecided(%)
PDMS helps savetime 68 10 22
PDMS faciliatescompliance
with standards of therapy
66 16 18
PDMS supports therapy-
planning
42 12 46
PDMS faciliatestherapeutic
decision
34 14 52
*PatientData Management Systems in Critical Care
REINHOLD FRETSCHNER, WOLFGANG
BLEICHER, ALEXANDRA HEININGER, and
KLAUS UNERTL
KlinikfürAnaesthesiologiederUniversität
Tübingen, Tübingen, Germany
PDMS are intended to
provide information which is
used to take decisions with
diagnosis or therapeutic
purposes!
Class IIa
Whataboutrule11?

20. [email protected]
Rule 11 –subruleb)
SoftwareintendedtomonitorphysiologicalprocessesisclassifiedasclassIIa,
exceptifitisintendedformonitoringofvitalphysiologicalparameters,where
thenatureofvariationsofthoseparametersissuchthatitcouldresultin
immediatedangertothepatient,inwhichcaseitisclassifiedasclassIIb.

21. [email protected]
Sub-rule 11 b) -MDCG 2019-11
Sub-rule11b)wasintroducedtoensurethatMDSWwhichhasthesame
intendedpurposeas(hardware)deviceswhichwouldfallunderrule10,third
indent,areinthesameriskclass.
However,thissubruleappliestoMDSWintendedtobeusedformonitoring
any/allphysiologicalprocessesandnotjustvitalphysiologicalprocesses
(equivalenttorule10,thirdindent).
Vitalphysiologicalprocessesandparametersinclude,forexample,respiration,
heartrate,cerebralfunctions,bloodgases,bloodpressureandbody
temperature.
the sameintendeduse implentedin a pure hardware MD, and in a pure software
MD havetwodifferentclassifications.
monitoring NON vital
physiological processes
Hardware MD
Class I
Software MD
Class IIa/IIb
Isa Art 51 violation?

22. [email protected]
MDR Art. 51
Art.51:DevicesshallbedividedintoclassesI,
IIa,IIbandIII,takingintoaccounttheintended
purposeofthedevicesandtheirinherentrisk.
<omissis>
Devicescannotbedividedintoclasses,
takingintoaccountthe«devicedesignand
constructionmethods»
IsRule 11 complaintwith Art. 51?

23. [email protected]
Medical Device Software (MDSW) MDCG 2019-11
Medical device software (MDSW) is a term used throughout
this document and shall be meant as all software that is
intended to be used, alone or in combination, for a medical
purpose specified in the definition of a “medical device” in
the MDR or IVDR, regardless of whether the software is
independent or is driving or influencing the use of a
device.
MDCG 2019-11 MDSW <> SaMD

24. [email protected]
WhataboutRule11 and Art. 51?
SaMDstandalone isfor suremore dangerousthanMD
hardware and MD firmware. SaMD(standalone) is
running intonotstrictlycontrolledenvironment(low
controls for operatingsystems, hardware, otherrunning
software /SOUP, antivirus).
If (Software = SaMD) then
Software in Rule 11 complieswith Art. 51.

25. [email protected]
Reductio ad absurdum. Rule11 vs art. 51
absurdum
Software embedded(i.e. firmware) ismore dangerousthanhardware
Software embedded(i.e. firmware) issafeashardware. Really, there is
no difference at all between hardware and firmware: some CPUshas
microcode(=firmware) thatrunsinside processors. Firmware isrunning
in a strictlycontrolledenvironment.
Thereisno reasonthatsoftware embedded part of hardware MD, is
more dangerousthan«pure» hardware device.
Devices cannot be divided into classes, taking
into account the device design and construction
methods
Devices shall be divided into classes I, IIa, IIband III,
taking into account the intended purpose of the devices
and their inherent risk
If (Software = MD firmware ) then
Rule 11 Software = SaMD

26. [email protected]
Usability of the IMDRF risk classification framework in the context
of the MDR -MDCG2019-11
Significance of Information provided by the
MDSW to a healthcare situation related to
diagnosis/therapy
State of Healthcare
situation or condition
High
Treat or
diagnose
~ IMDRF 5.1.1
Medium
Drives clinical
management
~ IMDRF 5.1.2
Low
Informs clinical
management
(everything
else)
Critical
situation or
condition
~ IMDRF 5.2.1
Class III
Type IV.i
Class IIb
Type III.i
Class IIa
Type II.i
Serious
situation or
condition
~ IMDRF 5.2.2
Class IIb
Type III.ii
Class IIa
Type II.ii
Class IIa
Type I.ii
Non-serious
situation or
condition
(everything
else)
Class IIa
Type II.iii
Class IIa
Type I.iii
Class IIa
Type I.i
The IMDRF codesare invertedfrom whatdefinedin IMDRF document!!!!!!

27. [email protected]
Factors Important for SaMDcharacterization
The intended use of the information provided by SaMDin clinical
management has different significance on the action taken by the
user:
1.Treat or diagnose
2.Drive clinical management
3.Inform clinical management

28. [email protected]
To treat or to diagnose
Treating and diagnosing infers that the information provided by the SaMD
will be used to take an immediateor near term action:
•To treat/prevent or mitigateby connecting to other medical devices,
medicinal products, general purpose actuators or other means of
providing therapy to a human body
•To diagnose/screen/detect a disease or condition (i.e., using sensors,
data, or other information from other hardware or software devices,
pertaining to a disease or condition).
We can take (immediate) decisions with diagnosis or therapeutic purposes

29. [email protected]
To drive clinical management
Driving clinical management infers that the information provided by the SaMD
will be used to aidin treatment, aidin diagnoses, to triage or identify early
signs of a diseaseor condition will be used to guide next diagnostics or next
treatment interventions:
•To aidin treatment by providing enhanced support to safe and effective
use of medicinal products or a medical device.
•To aidin diagnosis by analyzing relevant information to help predict risk of
a disease or condition or as an aid to making a definitive diagnosis.
•To triage or identify early signsof a disease or conditions.
We can (aid to) take decisions with diagnosis or therapeutic purposes

30. [email protected]
To Inform clinical management
Informing clinical management infers that the information provided by the
SaMDwill nottrigger an immediateor near term action:
•To inform of options for treating, diagnosing, preventing, or mitigating a
disease or condition.
•To provide clinical information by aggregating relevant information (e.g.,
disease, condition, drugs, medical devices, population, etc.)
We can take decisions (non-immediate) withdiagnosis or therapeutic purposes

31. [email protected]
Factors Important for SaMDcharacterization
The intended use of the information provided by SaMDin clinical
management has different significance on the action taken by the
user:
1.Treat or diagnose
2.Drive clinical management
3.Inform clinical management
1....Immediate..
2.…To Aid…
3...Non-immediate...
decisions with
diagnosis or
therapeutic
purposes

32. [email protected]
IMDRF SaMDCategories
State of
Healthcare
situation or
condition
Significance of information provided by SaMDto
healthcare decision
Treator
diagnose
Drive clinical
management
Informclinical
management
Critical IV III II
Serious III II I
Non-seriousII I I

33. [email protected]
IMDRF SaMDCategories
State of
Healthcare
situation or
condition
Significance of information provided by SaMDto
healthcare decision
diagnosis or therapeutic purposes always involved
Treator
diagnose
Immediate
Drive clinical
management
aid
Informclinical
management
Non-immediate
Critical IV III II
Serious III II I
Non-seriousII I I

34. [email protected]
Considerandum58 (serious adverse event)
“serious adverse event” means any adverse event that led to any of the following:
a)death,
b)serious deterioration in the health of the subject, that resulted in any of
the following:
i.life-threatening illness or injury,
ii.permanent impairment of a body structure or a body function,
iii.hospitalisationor prolongation of patient hospitalisation,
iv.medical or surgical intervention to prevent life-threatening illness
or injury or permanent impairment to a body structure or a body
function,
v.chronic disease,
c)foetaldistress, foetaldeath or a congenital physical or mental impairment or
birth defect;

35. [email protected]
IMDRF Critical vs MDR Serious
IFMDR Guide (Critical condition) MDR Serious«condition»
Situations or conditions where accurate and/or timely diagnosis or
treatment action is vital to avoid death, long-term disability or other
serious deterioration of health of an individual patient or to mitigating
impact to public health. SaMDis considered to be used in a critical
situation or condition where:
•The type of disease or condition is:
oLife-threateningstate of health, including
incurable states,
oRequires major therapeutic interventions,
oSometimes time critical, depending on the
progression of the disease or condition that could
affect the user’s ability to reflect on the output
information.
•Intended target population is fragile with respect to the
disease or condition (e.g.,pediatrics, high risk population,
etc.)
•Intended for specialized trained users.
a)serious deterioration in the health of the subject, that
resultedin any of the following:
i.life-threateningillness or injury,
ii.permanent impairment of a body structure or a body
function,
iii.hospitalisationor prolongation of patient hospitalisation,
iv.medical or surgicalintervention to prevent life-
threatening illness or injury or permanent
impairmentto a body structure or a body function,
v.chronic disease,
MDR Rule 11 : a serious deterioration of a
person's state of health or a surgical
intervention (IIb)
MDR Rule 11 : deathor an
irreversible deterioration of a
person's state of health (III)
WARNING: A life-threateningdisease is a very serious one that can cause death!

36. [email protected]
MDR inconsistency
life-threateningdisease (➔may cause death)andan
irreversible deterioration of a person's state of health
seems included inaserious deterioration in the health
of the subject (see Considerandum58)
Software intended to provide information which is used to take decisions
with diagnosis or therapeutic purposes is classified as class IIa, except if
such decisions have an impact that may cause:
•deathor an irreversible deterioration of a person's state of health,
in which case it is in class III; or
•a serious deterioration of a person's state of health or a surgical
intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class
IIa, except if it is intended for monitoring of vital physiological parameters,
where the nature of variations of those parameters is such that it could
result in immediate danger to the patient, in which case it is classified as
class IIb.
All other software is classified as class I
!?

37. [email protected]
Serious situation or condition (IMDRF)
Situations or conditions where accurate diagnosis or treatment is of vital importance to avoid
unnecessary interventions (e.g., biopsy) or timely interventions are important to mitigate long term
irreversible consequences on an individual patient’s health condition or public health.
SaMDis considered to be used in a serious situation or condition when:
•The type of disease or condition is:
oModerate in progression, often curable,
oDoes not require major therapeutic interventions,
oIntervention is normally not expected to be time critical in order to avoid death, longterm
disability or other serious deterioration of health, whereby providing the user an ability to detect
erroneous recommendations.
•Intended target population is NOT fragile with respect to the disease or condition.
•Intended for either specialized trained users or lay users.
Note: SaMDintended to be used by lay users in a "serious situation or condition" as described here,
without the support from specialized professionals, should be considered as SaMDused in a "critical
situation or condition".
Seriuouscondition(IMDRF guide) Non-Seriouscondition(MDR)

38. [email protected]
MDR ClassificationusingIMDRF guide
State of
Healthcare
situation or
condition
(IMDRF)
Significance of information provided by SaMDto
healthcare decision (always
Treator
diagnose
Drive clinical
management
Informclinical
management
Critical IIb IIb IIb
Serious IIa IIa IIa
Non-seriousIIa IIa IIa
Non-seriousMDR
seriousMDR

39. [email protected]
Better one ☺
Significance of Information provided by the
MDSW to a healthcare situation related to
diagnosis/therapy
State of Healthcare
situation or condition
High
Treat or
diagnose
~ IMDRF 5.1.1
Medium
Drives clinical
management
~ IMDRF 5.1.2
Low
Informs clinical
management
(everything
else)
Critical
situation or
condition
~ IMDRF 5.2.1
Class III/IIb
Type IV.i
Class III/IIb
Type III.ii
Class III/IIb
Type II.iii
Serious
situation or
condition
~ IMDRF 5.2.2
Class IIa
Type III.i
Class IIa
Type II.ii
Class IIa
Type I.ii
Non-serious
diagnostic or
therapeutic
actions
Class IIa
Type II.i
Class IIa
Type I.i
Class IIa
Type I.iii

40. [email protected]
ExampleII.i–MDCG 2019-11 (pag. 27)
MDSW intended to rank therapeutic suggestions for a health care professional
based on patient history, imaging test results, and patient characteristics, for
example, MDSW that lists and ranks all available chemotherapy options for
BRCA-positive individuals, should be classified as class IIaper Rule 11(a)
‾IMDRF Risk Category II.ias it informs clinical management for cancer, a
critical disease.
State of
Healthcare
situation or
condition
Significance of information provided by
SaMDto
healthcare decision
Treator
diagnose
Immediate
Drive clinical
management
aid
Inform
clinical
management
Non-
immediate
Critical IV III II
Serious III II I
Non-seriousII I I
II.iiiSaMDthat provides information to
inform clinical management for a
disease or conditions in a critical
situation or condition is a Category II
and is considered to be of
medium impact.
Class IIb/III

41. [email protected]
TypeII.iiiIMDRF ➔III/IIbMDR
Software intended to provide information
which is used to take decisions with
diagnosis or therapeutic purposes
<when> such decisions have an impact that
may cause:
•death or an irreversible deterioration of
a person's state of health, in which case
it is in class III (?)
•a serious deterioration of a person's
state of health or a surgical intervention,
in which case it is classified as class IIb
Significance of
Information
provided by the
MDSW to a
healthcare
situation related
to diagnosis/
therapy
State of Healthcare
situation or
condition
Low
Informs clinical
management
(everything else)
Critical
situation or
condition
~ IMDRF 5.2.1
Class IIa
Class III(?)/IIb
Type II.iii
Software can cause a (non immediate)
criticalcondition(a serious deterioration
of a person's state of health or a surgical
intervention, life-threatening illness or
injury included )
III(?)/IIb
critical
condition
Itisnot«II.i» !

42. [email protected]
Conclusions
•IMDRF definitionsdo notmapthe MDR
definitions
•Doesthe MDSW definition comply with MDR
Rule11 and Art. 51?
•Thereisalotofmistakes
•Some Examplesand the flow chart are nearly
the samein MDCG2019-11 asin the old
MEDDEV 2.1/6 (itseamsdo nottake into
account the new rule 11)
This guideline is not legally binding,
but… please justifyanydeviation
Stay tunnedfor video lesson! ☺