IVDR Classification-

practical considerations

Avril Aylward, IVD Operations Manager, Medical Devices Department

HPRA Webinar Series on Medical Devices and in vitro diagnostic medical devices (IVDs)

10th November 2020

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 Agenda

IVDR IVDR
IVDR
implementation Classificatio Classificatio
Classificatio
–many n Rules & n Examples
n Guidance
challenges Principles
remain

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 Challenges on the path to IVDR implementation

201 2018 2019 2020 2021 2022 2023 2024

7

Entry into 26 May 2022 May 2024

force Date of Expiration of
May 2017 18 months application all
IVDD Certs IVDD Certs
can no
longer be
issued
EC Certs remain valid

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 Classification rules & principles

Ref. (EU) 2017/746 Chapter V Article 47 Classification of Devices and Annex VIII
Annex VIII Annex VIII Class A
Define Intended
Implementing Classification
Purpose
Rules Rules
1.1 to 1.10 1 to 7 Class Class
D B

Analyte 1.1 Intended 1.6 Controls Rule 1 Blood/Tissue

screening high risk, life- Class C
Device type purpose threatening diseases (D

Sample type 1.2 Use in 1.7 Consider all rules

Purpose Combination Rule 2 Blood and/or tissue Rule 5 Products for general
lab use (with a specific
compatibility (C) High Risk
Clinical 1.8 Higher classification Blood Groups (D) medical purpose), General
1.3 Accessories culture media, Instruments,
application
End user
always applies/multiple
IPs Specimen receptacles (A)
Rule 3 Pre-natal screening,
Environment 1.9 Higher classification
1.4 Software Cancer, CDx, Genetic tests,
Rule 6 Devices not covered
Patient applies if several rules
apply
Congenital screening
by Rules 1-5 (B)
demographics
1.10 Each rule applies to
1.5 Calibrators first line/supplemental
Rule 4 Self-testing devices
(C), Exceptions listed (B), Rule 7 Controls without a
and confirmatory assays quantitative or qualitative
Near-patient tests classified
in their own right assigned value (B)

Ref. (EU) 2017/746 Article 2 – Definitions; Article 3 - Regulatory status of products

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 Example 1…Syphilis Test

Annex VIII Annex VIII

Define Intended
Implementing Classification
Purpose
Rules Rule 1
1.1 to 1.10
Class
Intended to
screen
1.1 Intended
purpose
1.6 Controls Rule 1 First indent D
blood and
1.2 Use in 1.7 Consider all rules Detection/presence/e
tissue
Combination xposure transmissible
donations
agent, blood / tissue
1..3 Accessories 1.8 Higher
classification always compatibility
applies/multiple IPs

1.4 Software 1.9 Higher

classification applies
if several rules apply

1.5 Calibrators 1.10 Each rule applies

to first
line/supplemental
and confirmatory
assays

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 Example 2…Syphilis Test

Annex VIII Annex VIII Annex VIII

Define Intended
Implementing Classification Classification
Purpose
Rules Rule 1 & 2 Rule 3
1.1 to 1.10

Intended to 1.6 Controls Rule 3a a sexually Class

1.1 Intended
be used for
diagnosis
purpose
transmitted agent C
in the 1.2 Use in 1.7 Consider all rules
individual Combination
1.3 Accessories 1.8 Higher
classification always
applies/multiple IPs

1.4 Software 1.9 Higher

classification applies
if several rules apply

1.5 Calibrators 1.10 Each rule applies

to first
line/supplemental
and confirmatory
assays

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 Classification Guidance

Useful Guidance
on IVDR
Classification Rules
application
Expert
Group MDCG, CA’s,
EU Comm, • Definitions
NB’s, Industry
• Principles
• Examples
• 7 Risk based
rules in detail

Due to be
published in the
near future

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 Class A, B, C, D…Examples

*Examples shown are for illustrative purposes. Final device classification depends on the intended purpose of the device & correct application of Regulation (EU)
2017/746

Class A Class C
Class A Class B Class C Class D

Class B Class D
HCV
HIV

HB
V

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 Example 3…Non-typhoidal anti-salmonella antibodies

Annex VIII Annex VIII

Define Intended
Implementing Classification
Purpose
Rules Rule 1
1.1 to 1.10
Rule 1

1.1 Intended 1.6 Controls Detection/presence/exp

Enzyme osure transmissible
immunoassay purpose 1.7 Consider all rules agent, to assess blood /
reagent to detect 1.2 Use in tissue compatibility (D)
exposure to an Combination 1.8 Higher classification
infectious agent always applies/multiple Detection
non-typhoidal 1.3 IPs presence/exposure to a
Accessories transmissible agent that
salmonella in cause life threatening
human blood 1.9 Higher classification
1.4 Software applies if several rules disease + high risk
apply propagation

1.5 Calibrators 1.10 Each rule applies to Detect infectious load of

first line/supplemental life-threatening disease
and confirmatory assays where monitoring is
critical

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 Example 3…Non-typhoidal anti-salmonella antibodies

Annex VIII Annex VIII

Classification Classification
Rule 2 Rule 3

Rule 2 Rule 3a Rule 3d Rule 3g

Blood and/or tissue sexually transmitted Prenatal screening disease staging,

compatibility (C) agent erroneous result life
High Risk Blood threatening
Groups (D) Rule 3b
Rule 3e
presence in Rule 3h
infective/immune
CSF/blood of
status, erroneous screening/diagnosis
infectious agent +
result-life /staging cancer
high propagation,
threatening
Abs not covered
Rule 3f Rule 3i
Rule 3c
Companion Human genetic
3c presence of an Diagnostics testing
infectious agent, risk
of death/severe
disability, Abs not
covered

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 Example 3…Non-typhoidal anti-salmonella antibodies

Annex VIII
Classification
Rule 3

Rule 3j Rule 3k Rule 3l Rule 3m

monitoring levels, management of congenital congenital

erroneous result-life patient suffering disorders- disorders-newborns
threatening from life threatening embryo/foetus
disease

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 Example 3…Non-typhoidal anti-salmonella antibodies

Annex VIII Annex VIII Annex VIII Annex VIII

Class
Classification Classification Classification Classification
Rule 4 Rule 5 Rule 6 Rule 7

B
Rule 4a Self-tests are Rule 7 Devices which
Class C
Rule 5a General Rule 6 Devices not
lab products, no covered by rule 1 are controls without a
Except for devices for the
detection of pregnancy, critical to 5 (B) quantitative or
fertility, cholesterol, characteristics qualitative assigned Enzyme
glucose, erythrocytes, value are classified as immunoassay
leucocytes and bacteria in
urine which will be Class B Class B reagent to detect
exposure to an
Rule 5b infectious agent
Instruments non-typhoidal
Rule 4b devices for near
intended for IVD
patient testing-classified salmonella in
in own right use
human blood

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 Example 4…SARS-CoV-2 Rapid Antigen Test

Annex VIII Annex VIII

Define Intended
Implementing Classification
Purpose
Rules Rule 1
1.1 to 1.10
TC
Rule 1 Class
Flo
1.1 Intended 1.6 Controls
Detection/presence/exp
D
w purpose 1.7 Consider all rules osure transmissible
Lateral flow 1.2 Use in agent, blood / tissue
immunoassay compatibility (D)
Combination 1.8 Higher classification
intended for the always applies/multiple
rapid qualitative 1..3 IPs Detection/presence
detection of Accessories transmissible agent
that cause life
nucleocapsid 1.9 Higher classification
1.4 Software applies if several rules threatening disease +
protein antigen high risk propagation
apply
from SARS-CoV-2
in nasal swabs. 1.5 Calibrators 1.10 Each rule applies to Detect infectious load
For professional first line/supplemental of life-threatening
use only. and confirmatory assays disease where
monitoring is critical

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 Software Qualification & Classification

Qualification & Annex VIII Annex VIII Class A

Intended
Purpose
Consult MDCG 2019-11 Guidance on
Qualification and Classificationof
Software in Regulation (EU)
2017/745 – MDR and Regulation
(EU) 2017/746 – IVDR October 2019
A set of instructions that processes
input data and creates output data
SW must have a medical purpose on
its own to be qualified as MDSW
Software in its own right + medical
purpose + IVD
Implementing Classification Rules
Rules 1 to7
1.1 to 1.10 Class Class
D B
1.4 Software, which Rule 1 Blood/Tissue
drives a device or screening high risk, life-
influences the use of a threatening diseases (D Class C
device, shall fall within
the same class as the
device. Rule 5 Products for general
Rule 2 Blood and/or tissue
lab use (with a specific
compatibility (C) High Risk
If the software is
Blood Groups (D) medical purpose), General
independent of any
culture media, Instruments,
other device, it shall be
Specimen receptacles (A)
classified in its own
right. Rule 3 Pre-natal screening,
Cancer, CDx, Genetic tests,
Rule 6 Devices not covered
1.9 If several Congenital screening
classification rules by Rules 1-5 (B)
apply to the same
device, the rule Rule 4 Self-testing devices
resulting in the higher (C), Exceptions listed (B), Rule 7 Controls without a
classification shall Near-patient tests classified quantitative or qualitative
apply. in their own right assigned value (B)

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 Companion Diagnostics Example

Definition of Annex VIII Annex VIII Annex VIII

Define Intended Implementing Rules
companion Classification Classification
Purpose 1.1 to 1.10
diagnostic Rule 1 & 2 Rule 3

Rule 3f Class
C
‘Companion diagnostic’ (CDx) CDx assay intended
is defined in Article 2(7) (EU) for the qualitative
2017/746 detection of a specific companion
protein associated diagnostics
Companion diagnostics are
defined in the IVDR as devices
with lung cancer in are Class C
essential for the safe and tissue , and is
effective use of a indicated as an aid in
corresponding medicinal identifying patients
product, to identify, before eligible for treatment
and/or during treatment, with crizotinib or
either patients who are most ceritinib.
likely to benefit from that
medicinal product or patients
likely to be at increased risk of
serious adverse reactions as a
result of treatment with the
corresponding medicinal
product.

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 Not a companion diagnostic

Define Intended Define Intended

Purpose Purpose

INR Blood glucose

test intended for use monitor intended to
by professional measure the level of
healthcare providers blood glucose in
for quantitative human blood
prothrombin time
testing for the
monitoring of
warfarin therapy

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 Take Away…

IVDR Consider
implementatio Importanc both Consult HPRA
n –many e of implementin the classificatio
challenges intended g and Guidance n process
remain purpose classification
rules

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 Questions
Further information:
???
• HPRA email address for implementation queries:
eudr@hpra.ie

• https://ec.europa.eu/health/sites/health/files/md_topics-
interest/docs/md_mdcg_2019_11_guidance_en.pdf

• CAMD website- www.camd-europe.eu

• Notified bodies- https://ec.europa.eu/growth/tools-

databases/nando/

• avril.aylward@hpra.ie

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Thank You

© HPRA 2020.
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