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RAPS Certification > EU - Chapter 2 > Flashcards

EU - Chapter 2 Flashcards

1
Q

___________, _________, and ___________ are legally binding, whereas ___________ and _________ are not.

A

regulations, directives, decisions

recommendations, opinions

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2
Q

A ________ is directly applicable in all states.

A

regulation

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3
Q

A _________ must be transposed into national law and administrative provisions.

A

directive

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4
Q

__________ defines the EU’s legal acts.

A

Treaty Article 288

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5
Q

Each member state is free to decide on the nature and contents of texts adopted nationally, but it must achieve the _________ intended results.

A

directive’s

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6
Q

A _______ applies to those to whom it is addressed.

A

decision

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7
Q

Proposal from the EC where regulations, directives, and decisions are adopted jointly by the European Parliament and the Council is called ______.

A

co-decision procedure

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8
Q

The co-decision procedure is defined in _________.

A

Treaty Article 294

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9
Q

Legislative texts are called _______ directives instead of ________ directives.

A

commission, council

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10
Q

Medical device directives based on ________ _________ regulatory philosophy.

A

New Approach

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11
Q

The directive/regulation reference for MDD is …

A

93/42/EEC

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12
Q

The directive/regulation reference for Medical Devices: active implantable is…

A

90/385/EEC

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13
Q

The directive/regulation reference for medical devices: in vitro diagnostic is…

A

98/79/EC

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14
Q

1993 was the date a single market was created. what was the key challenge?

A

Drafting product-oriented directives to eliminate tech. barriers to trade hindering the free movement of goods in the single market.

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15
Q

Opposite of detailed legislative approach is…

A

New Approach

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16
Q

The New Approach established principles for …

A

legalization harmonization

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17
Q

These principles include:

A

Essential requirements, technical specifications, voluntary application of of harmonized or other standards, products manufactured in compliance with harmonized standards mean conformity with ER.

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18
Q

A qualified majority is…

A

at least 55% of Council members, comprising at least 15 who represent member states comprising at least 65% of EU population.

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19
Q

A blocking minority is…

A

at lest 4 council members or the qualified majority shall be attained.

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20
Q

The New Approach principles are applied in MDD as follows…

A
  1. Manufacturer must demonstrate its products comply with ER (prove devices perform as intended and patient benefits outweigh risks)
  2. ER are general in content but detailed technical explanations are found in voluntary harmonised standards (HS).
  3. Demonstrated compliance with HS creates presumption of compliance w/ corresponding ER.
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21
Q

Compliance with ER confirmed by…

A

CE mark and DoC once manufacturer convinced achieved compliance w/ MDD w/ TF demonstrating conformity to ER and QS appropriate for risk profile of device.

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22
Q

Can a EU member state oppose CE mark unless…

A
  1. device is unsafe (principle of safeguard) or threat to health and safety (precautionary principle) or CE mark is wrongly affixed (failure to comply w/ legal requirements).
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23
Q

CE mark is beginning of compliance as…

A

MDD impose cyclical clinical evaluation process on manufacturer.

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24
Q

The cyclical clinical evaluation is aimed at…

A

continuous device improvement and clinical substantiation in TF.

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25
Q

MEDDEV 2.12/2 Rev. 2 is…

A

Post Market Clinical Follow-up Studies.

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26
Q

MEDDEV 2.12/2 Rev. 2 discusses…

A

EU guidance on postmarket clinical follow up studies & how manufacturer and NB work together toward goal of improving device’s substantiation.

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27
Q

Clinical evaluation requires…

A

collection of clinical data to establish device’s conformity with Annex’s I ER for its characteristics & performance under normal conditions of use, evaluation of side effects, and acceptability of B-R profile.

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28
Q

Clinical evaluation means…

A

process of evaluating clinical evidence to support safety and performance.

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29
Q

Clinical investigation means…

A

clinical trials which is part of clinical evaluation to substantiate safety & performance not confirmed in literature.

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30
Q

PMCF stands for …

A

postmarket clinical follow up

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31
Q

NLF stands for …

A

new legislative framework

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32
Q

NLF means…

A

package of measures aimed at improving market surveillance & boosting conformity assessment quality.

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33
Q

The practical implication of NLF for medical device industry is…

A

tightening NB accreditation & creating special requirements for certain economic operators (EO) (D, I, and AR).

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34
Q

The new version of Blue Guide includes detailed guidance on e.g.,

A

obligations of EO or accreditation, standardization & market surveillance.

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35
Q

EU member states must transpose…

A

MDD requirements into their national laws and enforce them.

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36
Q

Specific responsibilities of the member states are 4-fold and include…

A

register manufacturers or AR, assess clinical trial applications, act as CA for NB, and centrally evaluate adverse events.

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37
Q

Member states have what to enforce their responsibilities?

A

CA

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38
Q

How many member states have common authority for medicinal products and devices?

A

28

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39
Q

NB are ________ organizations.

A

certification

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40
Q

NB are…

A

notified by member states to the commission after 1st being designated by member state.

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41
Q

NB operate on mandates from…

A

member states after compliance with requirements of MDD Annex XI confirmed.

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42
Q

Responsibilities of NB include:

A
  1. assessing manufacturer’s compliance with EU medical device’s requirements; 2. attesting to such compliance by granting certificates; 3. monitoring compliance via periodic scheduled and unannounced audits.
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43
Q

The nature of NB involvement depends on…

A

product’s class.

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44
Q

A NB will not get involved with class I device unless it’s…

A

sterile or measuring device.

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45
Q

___ NB in EU.

A

60

46
Q

NB-MED is

A

collective NB organization.

47
Q

NB-MEDs role is:

A

pg. 20

48
Q

TEAM-NB is association of ___ and has ___ members.

A

NBs, 23

49
Q

TEAM-NB aims to…

A

pg. 20

50
Q

NB finds weaknesses in NB by:

A

performing supervisory audits of association members to verify implementation of the code (pg. 20) & adherence to its detail.

51
Q

EMA is

A

European Medicines Agency.

52
Q

EMA is responsible for

A

scientific evaluation of medicines.

53
Q

3 main standardization organizations are…

A
  1. European Committee for Standardization (CEN) 2. European Committee for Electrotechnical Standardization (CENELEC) 3. European Telecommunications Standards Institute (ETSI)
54
Q

What makes importers and, to a lesser extent, distributors, responsible for verifying products they handle are in compliance with EU requirements?

A

NLF

55
Q

MDD do not assign any clear _______ to healthcare establishments.

A

responsibilities

56
Q

Council directive 90/385/EEC relates to

A

AIMD

57
Q

Council directive 93/42/EEC relates to

A

MDD

58
Q

Council directive 98/79/EEC relates to

A

IVDD

59
Q

Software can be a medical device by itself if…

A

it does not come pre-installed on a device.

60
Q

The use for which device is intended according to the data supplied by manufacturer on labeling, in instructions, and/or promo material.

A

intended purpose

61
Q

Vet devices are regulated as medical devices (T/F)?

A

F

62
Q

Exclusions from MDD are:

A
  1. blood and blood products, plasma, blood cells 2. transplants or tissues or cells of human origin 3. transplants or tissues or cells of animal origin
63
Q

AMD means

A
  1. MD relying on a source of electrical energy or source of power other than that directly generated by human body or gravity.
64
Q

AIMD menas

A

any AMD intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice and remains after the procedure.

65
Q

Example of AIMD is

A

pacemaker.

66
Q

IVDD definition

A

pg. 25

67
Q

Example of IVDD

A

specimen receptacles

68
Q

MDD defines accessory as

A

article thats not a device but intended by the manufacturer to be used together with a device.

69
Q

For the purpose of the directive, accessories shall be treated as…

A

MD in their own right.

70
Q

Placing on the Market is core concept of MDD and is only allowed after

A

CE mark has been affixed lawfully on a valid DoC.

71
Q

Placing on the Market is defined…

A

1st making available in return for payment and occurs when product is transferred from manufacturing w/ intention of distribution or use on the Community market.

72
Q

Device displayed at e.g. trade fairs is not placed on the market which explains why these devices are not

A

CE marked.

73
Q

Putting in Service means

A

the stage at which a device has been made available to final user as being ready for use on the Community market for the 1st time.

74
Q

2 medical device categories exempt from full conformity assessment requirements for CE mark…

A

custom made devices and devices intended for clinical investigation.

75
Q

Custom-made and clinical investigation (CI) devices must fulfill requirements set out in __________ and must not bear _______.

A

MDD Annex VIII, CE mark.

76
Q

Devices for CI must: ___________ and __________.

A

controlled per Clinical Investigation Protocol (CIP), documented (from shipment to return/disposal)

77
Q

Manufacturer is person w/ responsibility for the ______, _________ and ________ of a device.

A

manufacture, packaging, labelling

78
Q

If a manufacturer has no EU presence, it must appoint ____________ as the contact point for the authorities.

A

Authorized Representative.

79
Q

If the adaptation takes the device outside its original _____, the party assembling or adapting constitutes the ____________.

A

intended purpose, manufacturer

80
Q

Based on __________, if a manufacturer doesn’t have registered place of business in a Member State, it shall designate a single ______________.

A

MEDDEV, a single EU AR

81
Q

AR is any natural or legal person(s) established in the __________, designated by the ________ and acts and may be addressed by authorities & bodies in the Community instead of the manufacturer w/ regard to the latter’s obligations under the ___________.

A

community, manufacturer, directive

82
Q

The MEDDEV contains useful guidance on the ______ b/t AR and __________ and supervision of its implementation by the manufacturer’s ______

A

agreement, manufacturer, NB

83
Q

MEDDEV emphasizes member state authorities’ expectations that an AR takes an independent position toward its _______ and actively reports persistent _________ to the authorities and rescinding its agreement with the manufacturer.

A

manufacturer, nonconformities

84
Q

The _______ provides interpretation in the form of guidance (MEDDEV) documents, consensus statements, and informative documents.

A

Commission

85
Q

MDEG stands for

A

Medical Device Expert Group

86
Q

_____ documents are not legally binding but represent ______ members’ consensus.

A

MEDDEV, MDEG

87
Q

NBOG stands for _______ , the group that issues guidance on ____.

A

Notified Body Operations Group, NBT

88
Q

The ______ provides a forum for building ________.

A

commission, consensus

89
Q

The __________, a national Competent authority can request other national CAs to provide opinions on specific borderline or classification issues. If __________ is not reached, the matter is passed for consideration to the _______ _______ __________ on classification and borderline. This group draws members from _________.

A

Helinski procedure, consensus, commission working group, MDEG

90
Q

Notified bodies are grouped in __________ which issues guidance relavant to ____ _____ _____

A

TEAM-NB, NB operations

91
Q

_________ most prolific publisher of documents, providing an interesting perspective on EU medical device laws.

A

Eucomed

92
Q

The EU maintains a list of ____ _______ ______

A

national Competent Authorities

93
Q

The EU has no ___ ___ regarding compliance with the ____ as ____ ____ are responsible for conformance.

A

enforcement powers, MDD, Member States

94
Q

Centralized enforcement of medical devices law is reflected in the new regulation.

A

True

95
Q

With MDR, role of clinical evaluation has ___ and more pressure has been put on ____ ____ to be stricter in their ____ and ___.

A

increased, NB, certifications, audits

96
Q

For EU, the ___ and ___ will replace ___ and ___ both which entered into force on ____.

A

MDR, IVDR, AIMDD/MDD, IVDD, 5/26/17

97
Q

MDR and IVDR have new article that covers ___ and ___ for the 1st time at EU level and are enforced by ___ ___ at the ___ level.

A

marketing, advertising, member states, national

98
Q

Under the new regulations, manufacturers must provide sufficient financial coverage , disproportionate to the risk.

A

False

99
Q

If a manufacturer not established in member state and has not complied with its obligations, the ___ ___ is legally liable for defective devices the same as manufacturer.

A

AR

100
Q

As a result of new MDR, many of the smaller AR will gain business.

A

False

101
Q

Under MDR, a reprocessor is not liable for device unlike the OEM.

A

False

102
Q

Under MDR, CA have a ___ role WRT product ___ claims.

A

facilitator, liability

103
Q

Each ___ in the ___ chain must check ____ of previous ___.

A

link, supply, compliance, link

104
Q

European laws are proposed by the ___ and debated and adopted by the ____ and ___ ___.

A

commission, council, European Parliament (EP)

105
Q

The Council represents the ___ ___ ___ and the EP represents the ___.

A

member state governments, citizens

106
Q

Medical devices are regulated by means of ___ ___ directives which contains very general requirements explained in detail in ___ ___ ___ whereby compliance is denoted by ___.

A

New Approach, harmonized technical standards, CE

107
Q

CE mark allows the device to be placed on the marker in all ___ ___ and other counties w/ ___ with ___.

A

Member States, agreements, EU

108
Q

Final responsibility for placing MD on market belongs to ___ ___ whose name is on ___ and ___ ___ ___.

A

legal manufacturer, label, DoC

109
Q

For ___ and ___ risk products the manufacturer must undergo conformity assessment by ___.

A

medium, high, NB

110
Q

Member States ___ are responsible for enforcing ___.

A

CA, compliance

111
Q

In the EU, ultimate responsibility for interpreting the law rests with ___.

A

CJEU

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