Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

MDE > Regulatory Affairs > Flashcards

Regulatory Affairs Flashcards

1
Q

Why do medical devices require strict regulations?

A

To protect the safety and wellbeing of patients and end-users

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Regulatory bodies have implemented regulations to ensure that MDs released on the market are:

A
  • Safe for intended use
  • Have medical benefit that exceeds risk
  • Fulfil requirements for intended use
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is a MD?

A

Any instrument, apparatus, appliance (used alone or in combination) to be used by human beings for the purpose of:
- Diagnosis, prevention, monitoring, tx
- investigation, replacement or modification of anatomy
- Control of conception
(NOT BY PHARMACOLOGICAL MEANS, although may be assisted by them)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

What is an active MD?

A

MD relying for its function on a source of energy other than energy of the body or gravity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is an active implantable MD?

A

An active MD intended to be introduced into the human body or a natural orifice

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is an in vitro diagnostic MD?

A

MD intended to be used in vitro for examination of. specimens

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is an intended use?

A

An intended use is how your medical device addresses (treats/alleviates) the medical condition you with to address

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is an indication for use?

A

An indication for use is the actual situational use of the device (specific medical need the device is used for)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

How are medical device companies structured to navigate regulatory needs?

A

They have different departments

  • Regulatory
  • Quality
  • R&D
  • Production, manufacturing
  • Legal
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is the regulatory department responsible for?

A

For advising through the design and development process
For submission to regulatory bodies for approval
It has pre-market, post-market and interfacing roles.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

How does the quality department work?

A

They are obligated to operate a QMS (Quality Management System)
They control quality internally

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

How does R&D work?

A

They lead the process to product realisation through design and development

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What do R&D look at?

A

User needs
User input
User output
Verification, validation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What is the purpose of the clinical department?

A

Demonstrate that clinical data supports MD’s performance, and that clinically known benefits outweigh risks

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Does proving clinical benefit always require a trial?

A

No, you may be able to use the equivalency argument
If an existing product is similar enough, you can prove it through the literature
- Can be sufficiently demonstrated by literature route or a combination of both
– Works well for well established. technologies
– Requires predicates that are biologically, technically and clinically equivalent

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What does Competent Authority do in EU market?

A

It controls the process and implementation of a directive

It is involved in Class I devices and clinical trial applications

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What does the Notified body do?

A

It enforces approvals and conducts surveillance audits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Where must the legal manufacturer be, for a MD sold on EU market?

A

Must be within the EU

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What happens if if there is no literature/predicates that are equivalent, and you need to prove clinical benefit?

A

You need to prove both performance and safety through 2 phase clinical trial

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What is the classification for medical devices in the EU defined by?

A

Invasiveness and exposure time

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What are the classes for MD in EU?

A

Class I
IIa
IIb
III

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What annex are these classes defined in?

A

Annex 8

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What else will these classes require?

A

A declaration of conformity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What annexes are used to demonstrate conformity?

A

9,10,11

25
Q

What is the purpose of annex 2?

A

It defines requirements for technical documentation content

26
Q

What is the purpose for annex 3?

A

It sets out requirements for post-market surveillance

27
Q

Where is the General Safety and Performance Requirement contained?

A

Contained in Annex I

28
Q

General Safety and Performance Requirement function

A

Requires that all devices must be safe for end use

29
Q

What is Eudamed

A

European database on medical devices

It should store all information on medical devices

30
Q

What is the unique divide identifier (UDI)?

A

Allows you to identify where device was made, the n it was made etc.
Made up of 2 parts (UDI-DI and UDI-PI)

31
Q

What is Common Specifications (CS)?

A

group-specific specifications that create a benchmark

32
Q

What will occur in a no deal Brexit?

A

CE marked products will be recognised in the UK

UK companies will likely need new validations to sell their products in EU

33
Q

What will occur if Brexit deal is finalised?

A

Mutual recognition
UK will have its own mark
UK - EU marks will be cross recognised

34
Q

Do EU territories all have the same requirements?

A

No, they each have their own individual requirements

35
Q

What pathways is the US FDA split into?

A

4 main ones
Exempted product (self-certification, well known devices)
510K (submission and approval with a predicate)
De novo (for novel devices at low risk)
PMA (pre-market approval)

36
Q

What branches is FDA approval split into

A

Devices
Biologics
Drugs

37
Q

In the US, what do you need to identify to classify your device? What happens once you have ascertained these?

A

-Review panel
- Product code
- Regulation number
You will now be able to identify device class and submission route

38
Q

What happens if you cannot identify a regulation number in the US?

A

You will need to apply as de novo /PMA

39
Q

What is equivalence based on?

A

Key items and justification / evidence to back it

It does not mean identical

40
Q

What is the 510k regulatory paradigm

A

it is based upon substantial equivalence

41
Q

What can you use to show equivalence for 510k

A

Multiple predicates

Reference devices

42
Q

What is a special 510k?

A

Essentially device modification
Focuses on changes ot
f product that is already marketed via 510k

43
Q

What is an abbreviated 510k?

A

Submission available to devices with lots of guidance documentation and established special controls

44
Q

What is de novo route?

A

Recent alternative route to PMA, if your device has no predicate
You are essentially petitioning the FDA to introduce a new classification code and regulation number that will cover your device.

45
Q

When is de novo applicable instead of PMA?

A

If you have low/moderate risk

46
Q

When is PMA used?

A

For riskiest devices

47
Q

How long is PMA process?

A

lengthy (6 months)

48
Q

How much is PMA process?

A

Over 250k

49
Q

What is Investigation Device Exemption?

A

It is the process to obtain approval to conduct safety and performance clinical trials within the US

50
Q

What is Humanitarian Device Exemption for?

A

A device developed to benefit patients with a diagnosis of rare conditions / ailments

51
Q

What does HDE do?

A

It means you are not required to demonstrate same effectiveness requirements as the others

52
Q

What is a big benefit of applying with the FDA?

A

You get a PRE SUBMISSION DISCUSSION

This means you can ask questions to the FDA and gain insight

53
Q

How is china as a secondary market?

A

It has its own regulatory process, it does not accept approval from other territories

54
Q

Which market is generally the last one to get access into?

A

China

55
Q

How are Canada and Australia as regular markets?

A

have mutual recognition with other approval territories

56
Q

What happens as the market becomes more third world?

A

Barriers to entry become lower

Requirements become fewer

57
Q

What is the Medical Device Single Audit Programme?

A

Combines the regulatory burden of surveillance audits worldwide into just one audit
Results in certificate allowing recognition

58
Q

What is a Declaration of Conformity?

A

Declaration of Conformity is the document officially certifying that your product fulfils the essential requirements in the applicable CE directives.

MDE (16 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions