Basics of In vitro diagnostics, Classification

and approval process(EU)

PARUL INSTITUTE OF PHARMACY

DEPARTMENT OF REGULATORY AFFAIRS

Prepared By: Guided By:

Name: Pawar Gaurav Mrs. Khyati Patel
Enrollment No: 2408212170007 Assistant Professor
TABLE OF CONTENTS:
1. Introduction
2. Classification
3. Approval Procedure for IVD
4. Regulation For IVD in European Union
5. References
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 INTRODUCTION
According to the EU-IVDR, In Vitro Diagnostic medical device means
“any medical device which is a reagent, reagent product, calibrator,
control material, kit, instrument, apparatus, piece of equipment,
software or system, whether used alone or in combination, intended by
the manufacturer to be used in vitro for the examination of specimens,
including blood and tissue donations, derived from the human body.
• Examples of IVD medical devices are pregnancy tests, urine test
strips, HIV, etc.

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CLASSIFICATION
Class Risk-based classification Examples
A • Low-Individual Risk • Specimen receptacles
• Low-Public Risk • Laboratory instruments
• Buffer solutions.
B • Moderate-Individual • Vitamin B12
Risk • Pregnancy tests
• Low-Public Risk • Fertility tests
C • Moderate-Individual • Genetic tests
Risk • Companion diagnostics
• High-Public Risk • Blood gas analysers
• Caner markers
• Rubella
D • High- Individual Risk • Blood grouping ABO
• High-Public Risk • Hepatitis B and C
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IVD CLASS APPROVAL BY NOTIFIED BODY:
IVDR CLASS Examples
Self- A • Specimen
Certification • Receptacles clinical chemistry analyser

Notified B • Pregnancy self-testing

body • Urine test strips
Approval • Cholesterol self testing
required
C • HLA typing
• Blood glucose testing
• Human genetic testing
D • Hepatitis B blood – donor screening
• HIV test
• ABO blood grouping
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IVDR CLASSIFICATION RULES:
1. Rule 1:
• Applicable for most of the devices in Class D
a) determination of infectious load of a life-threatening disease
b) transmissible agent in blood, cells, tissues or organs and
blood components.
2. Rule 2:
• Applicable for most of the devices majorly in Class C and few
in Class D
• Devices intended to be used for blood grouping, or tissue typing to
ensure the immunological compatibility of blood, blood
components, cells, tissue or organs that are intended for
transfusion or transplantation or cell 6
 IVDR CLASSIFICATION RULES:
3. Rule 3:
• Generally majority of the IVD devices falls under this category are
in Class C
• Device used for
(a) sexually transmitted disease
(b) foetus or embryo
(c) pre-natal screening of women
(d) infective disease status or immune status
(e) screening, diagnosis, or staging of cancer
(f) human genetic testing
(g) screening for congenital disorders in the embryo or foetus
(h) congenital disorders in new-born babies etc. 7
IVDR CLASSIFICATION RULES:
4. Rule 4:
• Majority of the Devices falls under Class C and few in Class B
Intended for self testing
5. Rule 5:
• Generally Class A devices falls under this
rule. solutions, washing
• solutions,
laboratory culture media, histological
use accessories such as stains used in IVD
procedures
buffer and also some instruments for In Vitro procedures and
specimen receptacles.

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IVDR CLASSIFICATION RULES:

6. Rule 6:
• Class B Devices are not covered in any above EU IVDR
classification (1-5) rules
7. Rule 7:
•Generally considered in Class B Devices • Devices
which are controls without a quantitative or qualitative
assigned value.

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DIFFERENCE BETWEEN MEDICAL
DEVICE AND IVDS
Medical Devices IVDS

More risk Less Risk

Come into direct contact with Does not come into direct
the patient contact with the patient

E.g. Pacemakers, e.g. pregnancy test, Hepatitis

Intraocular lenses. or HIV test
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 IVD APPROVAL PROCESS
Applicant

Classification as per
directive
(98/79/EC)

Class A Class B Class C Class D

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 IVD APPROVAL PROCESS

Class A Class B Class C Class D

CE Certification QMS required &

(Self Certified) ISO 13485

Detail Information
about IVD 12
 IVD APPROVAL PROCESS
Approval

Compliance with
the Essential
requirements of Audit of
Annex I All Class
IVD

EU Authorised Conductance of All Class

Representative Audit (B to D) Declaration of
conformity

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REGULATION FOR IVD IN EUROPE:

Regulation on in vitro diagnostic medical devices 2017/746

Directive 98/79/EC For in vitro diagnostic

medical devices(IVDD)

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IVD DIRECTIVES
Article 1 Scope,
definitions
Article 2 Placing on the market and putting
into
Article 3 service
Essential
requirements
Article 4 Free movement
Article 5 Reference to
standards
Article 6 Committee on Standards and Technical
Regulations
Article 7 ------
Article 8 Safeguard clause 15
IVD DIRECTIVES

Article 9 Conformity assessment procedures

Article 10 Registration of manufacturers and
devices Article 11 Vigilance procedure
Article 12 European databank
Article 13 ------
Article 14 Amendments to Annex II, and derogation
clause
Article 15 Notified bodies
Article 16 CE marking
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IVD DIRECTIVES
Article 17 Wrongly affixed CE marking
Article 18 Decisions in respect of refusal or
restriction

Article 19 Confidentiality
Article 20 Cooperation between Member States
Article 21 Amendment of directives
Article 22 Implementation, transitional provisions
Article 23 -------
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ANNEXES:
Annex I Essential Requirements
Annex II List Of Devices Referred To In Article
Annex III Ec Declaration Of Conformity
Annex IV Ec Declaration Of Conformity (Full
Quality Assurance System)

Annex V Ec Type-Examination

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ANNEXES:
Annex VI Ec Verification
Annex VII Ec Declaration Of Conformity Production
Quality Assurance)

Annex VIII Statement And Procedures

Concerning
Annex IX Devices For The
Criteria For Performance Evaluation
Designation Of
Notified Bodies
Annex X Ce Marking Of
Conformity 19
REFERENCES:
1.European In Vitro Diagnostic Medical Device Regulation
(EU- IVDR) [Internet]. Deloitte Netherlands. [cited 2024 May
12]. Available from:
https://www2.deloitte.com/nl/nl/pages/life-sciences-en-
gezondheidszorg/articles/european-in-vitro-diagnostic-device-
regulation-eu-ivdr.html

2. Explaining IVDR Classification for In Vitro

Medical Devices
[Internet]. www.greenlight.guru. Available from:
https://www.greenlight.guru/blog/ivdrclassification
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REFERENCES:
3.IVDR Classification, (In-Vitro Diagnostic Devices) -
I3CGLOBAL [Internet]. 2020. Available from:
https://www.i3cglobal.com/ivdr- classification/

4.This document is meant purely as a documentation tool and

the institutions do not assume any liability for its contents [Internet].
2003. Available from:
https://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:19
98L0079:20090807:EN: PDF

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THANK YOU !

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