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RAPS Certification > EU - Chapter 4 > Flashcards

EU - Chapter 4 Flashcards

1
Q

98/79/EC (EU IVDD) is replaced by

A

746/2017 (EU IVDR)

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2
Q

True or False:

Article 1(2) (b) of the IVDD defines an IVD as:
in vitro diagnostic medical device’ means any medical device which is a reagent,
reagent product, calibrator, control material, kit, instrument, apparatus, equipment, 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, solely or principally for the purpose of providing
information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients,
or
— to monitor therapeutic measures.”

A

TRUE

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3
Q

4 types of IVDs as defined by IVDD

A

1 - Higher risk IVDs to diagnose the indications in Annex II List A
2 - Lower risk IVDs to diagnose the indications in Annex II List B
3- Self-tests
4- all other IVDs diagnosing indications not in either of the Annex II Lists

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4
Q

Examples of IVDs used to provide information concerning a physiological state

A

menopause assay, ovulation assay, pregnancy test

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5
Q

Examples of IVDs used to provide information concerning a pathological state

A

HIV Assay, COVID 19 Assay

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6
Q

Examples of IVDs used to provide information concerning a congenital abnormality

A

Evaluation of the risk of trisomy 21

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7
Q

Examples of IVDs used to to determine the safety and compatibility with potential recipients

A

Determination of blood groups of the ABO system

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8
Q

Examples of IVDs used to monitor therapeutic measures

A

Digitoxin Assay (Digitoxin is a naturally occurring cardiac glycoside that is used to treat congestive heart failureand atrial fibrillation)

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9
Q

True or False

The IVD is used in vitro for the examination of a specimen derived from the human body and where such specimen is never reintroduced into the body.

A

True

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10
Q

True or False

The IVD may provide information either alone or in combination with other devices or products

A

True

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11
Q

True or False
A pulse oxymeter emitting light through the fingertip and absorbing infrared light, to measure the oxy/deoxyhemoglobin ratio is an IVD

A

False

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12
Q

Specimen receptacles’ are those devices, whether vacuum-type or not, specifically
intended by their manufacturers for ____________________________________________________.

A

Specimen receptacles’ are those devices, whether vacuum-type or not, specifically
intended by their manufacturers for

the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic
examination.

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13
Q

What is
“ an article which, whilst not being invitro diagnostic medical device, is intended specifically by its manufacturer to be used with a device to enable that device to be used together with a device to enable that device to be used in accordance with its intended purpose”

A

Accessory

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14
Q

Are needles, lancets swabs, mouth tubes IVD accessories?

A

No, because they are invasive sampling devices directly applied to the human body

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15
Q

True or False

IVDs for performance testing can carry CE mark.

A

False.

Cannot carry CE mark because their performance characteristics have not been established yet. However, they still should meet all directive requirements.

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16
Q

Research-only IVDs are

A
  • intended for research purposes and not subject to IVDD
  • lack clinical application and hence not medical devices
  • cannot carry CE Mark
  • must carry label “ Research Use Only”
17
Q

Are inhouse (home brew)developed IVDs subject to IVDD?

A

No

18
Q

What are the requirements for inhouse IVDs to be exempt from IVDD?

A
  • Must be manufactured and used within the same legal entity and in the same geopgraphical location
  • the test can be run only on specimens from patients from the same health institution
19
Q

Will inhouse IVDs be subject to IVDR?

A

Yes

The health institution should justify in its documentation that the target patient’s group’s specific needs cannot be met at the appropriate level by an equivalent device available in the market

20
Q

What is
“ an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment”.

A

Companion Diagnostics

21
Q

IVDR places Companion Diagnostics in a new risk class -

A

Class C

The notified body must seek a scientific opinion from EMA or a national competent authority on the suitability of the companion diagnostic to the medicinal product concerned.

22
Q

Annex I of IVDD ( Essential Requirements) is what Annex of IVDR?

A

Annex I of EU IVDR ( GSPR)

23
Q

Before signing the DoC and affixing the CE mark, the manufacturer must ensure its product meets

A

Annex I of IVDD ( Essential Requirements) also known as Annex I of EU IVDR ( GSPR)

24
Q

Which Harmonized Standard requirement manages risks associated with the device’s use?

A

ISO 14971

25
Q

Common Technical Specifications (CTS) of IVDD is what under EU IVDR

A

Common Specifications under EU IVDR and contains performance specifications

26
Q

CS (CTS) will include

A

GSPR - Annex I
Technical Documentation -Annex II
Technical Documentation on PMS - Annex III
Performance evaluation, performance studies and post-market performance follow-up - Annex XIII

27
Q

Which is the Harmonized Standard requirement for QSR and Vigilance procedures?

A

ISO 13485

28
Q

True or False

Technical Documentation should be available for only Annex II List A CE marked IVDs

A

False

All CE marked IVDs regardless of the risk class

29
Q

Annex II List A devices require a _______ to be submitted to the _______ when Annex IV ( EC Declaration of Conformity) is chosen

A

Design Dossier; NB

30
Q

Yes or No

EU IVDR introduces UDIs for IVDs

A

Yes

31
Q

Devices for _____ and ______ are excluded from elabeling

A

Devices for self testing and point of care testing are excluded from elabeling

32
Q

For Annex II products, NB will inspect the product’s _____and _______.

A

For Annex II products, NB will inspect the product’s quality and quality system’s conformity

33
Q

True of False

For Annex II A products, NB will inspect the product’s quality, quality system’s conformity and is in charge of batch release criteria

A

True

34
Q

What are the changes introduced by EU IVDR?

A

Page 56

35
Q

____ become jointly and severly liable with the manufacturer for product liabilty

A

AR

RAPS Certification (9 decks)

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