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By :Ritu Jain
Designation : Professor
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 Overview of Invitro diagnostic Regulation

⚫ What is an in vitro diagnostic product (IVD)?

In vitro diagnostic products are those reagents, instruments, and systems intended for use
in diagnosis of disease or other conditions, including a determination of the state of health,
in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are
intended for use in the collection, preparation, and examination of specimens taken from
the human body.

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 Classification of device as per Indian MDR

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Defination
⚫ IVD Directive : Members is free to decide how to transpose a directive in to national law
.Currently the safety and performance of in invitro diagnostic device are regulated in the EU by
the 1998.In Vitro diagnostic medical device directives (IVDD) .This sets a framework for
manufacture and for authorized representatives who seeks to place IVD products on EU

⚫ IVD Regulations : Has binding regal force throughout members state enter into force on a set
date in all the members states. The transition tome is 5 years and ends may 27,2022,utilize the
framework established from the IVDD ,with additional requirement for manufactures to place
IVD products on EU market.
⚫
⚫ Certificate: A formal attestation or confirmational a quality management system(ISO
certification ) or products) Notified Body certification ,Design Examination certification.

⚫ Accreditation : A process in which certification of competency ,authority or credibility is

presented .EXAMPLES : Notified bodies against IVDR or MDR ,Laboratories against ISO
15189: 2014 or 17025: 2018

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Regulations for In vitro diagnostic Medical
devices (IVDS )

⚫ A little bit of history

⚫ In the 80/90s in many countries IVDS were non regulated or regulated under the drug
laws and had the same or similar requirements as drugs.
⚫ In the mid 90s an effort started to harmonize laws and regulations not just European wide
but also internationally.
⚫ In the European community IVDs were classified as medical device but under a separate
directive : The IVD medical device directive (IVDD)as of 1998
⚫ The CE mark was the: “passport for Europe “free product movement between Eu
member stated .same safety and performance standard across Europe
⚫ The IVD directive and any following legislation applies to all manufactures of IVD
medical devices who wants to bring products on the European market or to import into
the European market

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 Invitro Diagnostics regulation in US
⚫ RegulatoryAuthority:
⚫ FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms
⚫ IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and
may also be biological products subject to section 351 of the Public Health Service Act. Like
other medical devices,

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 OVER VEIW OF INVITRO DIAGNOSTICS REGULATION (FDA)

⚫ CLASSIFICATION :
⚫ IVD regulation is risk-based, with tests falling into one of three regulatory categories. Tests are
classified in the lowest tier, Class I, if they pose relatively little risk to patients and the public
health if they are inaccurate (such as a cholesterol test). Moderate-risk tests, such as pregnancy
tests, are categorized as Class II, while tests in the highest risk tier, Class III, are considered to
pose the greatest potential risk if they are inaccurate (such as a genetic test used to select cancer
therapies). These categories correspond with increasing levels of regulatory scrutiny, with most
tests in Class I—and some in Class II—being exempt from premarket requirements, while most
Class II and all Class III tests require some form of premarket review before they can be used
with patients.

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 OVER VEIW OF INVITRO DIAGNOSTICS REGULATION (FDA)

⚫ Premarket Notification 510(k) - 21 CFR Part 807 Subpart E

⚫ If your device requires the submission of a Premarket Notification 510(k), you cannot
commercially distribute the device until you receive a letter of substantial equivalence from FDA
authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to
one legally in commercial distribution in the United States.

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OVER VEIW OF INVITRO DIAGNOSTICS REGULATION (FDA)

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 OVER VEIW OF INVITRO DIAGNOSTICS REGULATION (FDA)

⚫Premarket Notification 510k:

Predicate Device : The legally marketed device to which equivalence is drawn is known as the
predicate device .A claim of Substantial equivalence does not mean the device must be identical.
Substantial equivalence is established with respect to:
Intended use ,design ,Energy used or delivers ,materials ,Performance safety ,effectiveness
,Labelling ,biocompatibility,Standards,and other applicable characteristics

Substantially equivalent to your device

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 OVER VEIW OF INVITRO DIAGNOSTICS REGULATION (FDA)

⚫ 510 ( K) review
⚫ 90 Days
⚫ Same Classification as predicate device
⚫ If not SE ,Calssifed as IIS
⚫ P

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 MEDICAL DEVICE REGULATION IN
EUROPEAN COUNTRIES

⚫ The European union is a political and economic union of 28 members state that are primilarly
located in Europe

⚫ The drug approval process in European countries is also accomplished in two phases : Clinical
Trail & Marketing Authorization

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 MEDICAL DEVICE REGULATION IN
EUROPEAN COUNTRIES

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 THANKS

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