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Biomedical devices > Medical Device Regulation > Flashcards

Medical Device Regulation Flashcards

1
Q

Do medical devices use patients or health individuals for clinical trails?

A

Patients

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2
Q

What is regulatory affairs about?

A

Certain products, industries and business operations are ‘regulated’ by governmental oversight due to nature of products or services that are supplied, or activities being undertaken

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3
Q

What are the most regulated activities in the world?

A

Development, manufacturing, licensing & ongoing marketing of medical products

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4
Q

What are the main objectives of reg affairs?

A

Products are safe and effective

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5
Q

What are 3 things causing risk?

A

Intervention
Unknown factors
Vulnerable populations

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6
Q

What are 3 things bringing about benefits?

A

Scientific understanding
Clinical benefit
Risk management

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7
Q

What are 4 actors of medical device regulation in europe?

A

EC
Notified bodies
National Competent Authorities
National Designating Bodies

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8
Q

What organisation awards licenses in Ireland?

A

HPRA

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9
Q

What are 4 legal instruments?

A

Regulations
Decisions
Directives
Communications (not legalling binding)

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10
Q

What are the 3 primary directives?

A

general medical devices
In vitro diagnostic medical devices
Active implantable medical devices

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11
Q

What year were new regulations MD and IVD impleneted?

A

2017

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12
Q

What do essential requirements aim to ensure?

A

That medical devices are designed, manufactured and used such that unnecessary risks to patients and users are avoided
13

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13
Q

What is the difference between horizonatl & vertical standards?

A

Horizontal standard applied to anything
Vertical standards are device specific

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14
Q

What do European Harmonised standards provide?

A

Technical specifications for meeting the ‘Essential requirements’
Presumption of conformity

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15
Q

What is the CE mark?

A

Indicates conformance with Essential Requirements of appropriate device

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16
Q

What is CE mark not applicable for?

A

custom-made devices

17
Q

What are 4 classifications for in vitro devices?

A

general
self-test
Annex II List B
Annex II List A

18
Q

What 4 things does the classification of a medical device influence?

A

Pre-market requirements
Conformity assessment route
Clinical data requirements
Post-marker obligations

19
Q

How many notified bodies are there in Europe?

A

57

20
Q

What do the MDR and IVR represent?

A

Significant development & strengthening of existing regulatory system for medical devices in Europe & will replace original directives

21
Q

What are 6 primary changes with MDR & IVDR?

A

Scope - aesthetic devices
Enhanced transparency & traceability
Enhanced market surveillance
New IVD framework
Increased notified body requirements
Clinical data requirements

Biomedical devices (14 decks)

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