Brainscape's Knowledge GenomeTM

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


See full index

EU Medical Device Regulations > The European Medical Devices Legal System (Ch. 7) > Flashcards

The European Medical Devices Legal System (Ch. 7) Flashcards

1
Q

What is the Treaty on European Union (TEU)?

A

Treaty on European Union (TEU):
Sets out the European Union’s purpose, democratic principles, institutions and governance framework, as well as provisions on enhanced co-operation, external action and the EU’s common foreign and security policy

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

What is the Treaty on the Functioning of the European Union (TFEU)?

A

Treaty on the Functioning of the European Union (TFEU):
It forms the detailed basis of EU law by defining the principles and objectives of the EU and the scope for action within its policy areas. It also sets out organizational and functional details of the EU institutions.

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

European legislation is moving to a (centralized or de-centralized) system of regulations?

A

A more centralized system

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

Which types of EU legal acts are legally binding, and which are not?

A

Regulations, directives, and decisions = legally binding

Recommendations and opinions = not legally binding

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

What is a regulation?

A

Regulation: Legislation that is directly applicable in all Member States

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

What is a directive?

A

Directive: Legislation that must be transposed into national law
(Each Member State decides how it implements the directive, but it must achieve the directive’s intended results)

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

What is a decision?

A

Decision:

Applies to those to whom it is addressed

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

What is the co-decision procedure?

A

Regulations, directives, and decisions are adopted jointly by the EU Parliament and the Council, based on a proposal from the EU Commission

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

What is the MDD?

A

93/42/EEC

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is the AIMDD?

A

90/385/EEC

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

What is the IVD?

A

98/79/EC

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

What are the main principles of the “New Approach” regulatory philosophy?

A

New Approach:

  1. Essential requirements (ER’s) that products placed on the market must meet
  2. Technical specifications are in harmonized standards
  3. Application of harmonized standards is voluntary
  4. Compliance with harmonized standards have a “presumption of conformity” with the ER’s
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

How is compliance to the Essential Requirements verified?

A

Via a conformity assessment (i.e. technical file, QMS)

notified body may be responsible for evaluating the conformity assessment

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

What elements are required for a compliant medical device in the EU?

A
  1. Affix CE mark
  2. Issue a Declaration of Conformity
  3. Have a technical file
  4. Demonstrate conformity to the Essential Requirements
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What scenarios can a Member State oppose a CE-marked device?

A
  1. Device is unsafe - principle of safeguard
  2. Threat to health/safety - precautionary principle
  3. Wrongly affixed CE mark - failure to comply with legal requirements
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is the EU guidance on postmarket clinical follow-up studies?

A

MEDDEV 2.12/2 Rev. 2, Post Market Clinical Follow-Up Studies

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

What is clinical evaluation?

A

Clinical Evaluation:

The process of evaluating clinical evidence to support safety and performance

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

What are some considerations in a clinical evaluation?

A

Requires the collection of clinical data to establish the device’s conformity with ERs or GSPRs concerning its characteristics and performance under normal conditions of use, evaluation of its side effects, and acceptability of its benefit-risk profile

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

What is a clinical investigation?

A

Clinical Investigation, aka clinical trial

May be conducted as part of the clinical evaluation

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

What is the New Legislative Framework (NLF)?

A

New Legislative Framework (NLF):
A package of measures aimed at improving market surveillance and boosting conformity assessment quality, clarifies use of CE marking

  • Regulation (EC) 765/2008
  • Decision 768/2008
  • Regulation (EC) 764/2008
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What is the MDCG?

A

MDCG: Medical Devices Coordination Group

Includes the EU Member States and the Commission, deals with key issues in the medical device sector

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

What are the main responsibilities of Member States / other relevant countries?

A

To transpose directives’ requirements into their national laws and enforce them

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

What are the enforcement responsibilities of Member States / other relevant countries?

A
  1. Register manufacturers / Auth. Reps.
  2. Assess clinical trial apps
  3. Act as CA for Notified Bodies
  4. Centrally evaluate adverse events
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What additional responsibilities are added for Member States as part of the EU MDR / EU IVDR?

A

Obligations of cooperation and centralization of market surveillance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

What entity do Member States have for enforcing these responsibilities?

A

A National Competent Authority (NCA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

What are the Member States / other relevant countries?

A
  1. 27 Member States
  2. 3 EEA (European Economic Area) countries: Iceland, Liechtenstein, and Norway)
  3. Special EU agreements: Switzerland and Turkey
    (This is what the EU MDR refers to as the “Union”)

UK - no longer relevant #BREXIT

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Give a summary of BREXIT.

A

BREXIT
The UK left the EU on Jan. 31, 2020. The UK is no longer a formal EU Member State, and it does not participate in EU institutions. EU law applies until Dec. 31, 2020.
The EU and UK agree to a prolonged transitional period, where EU law applies for two more years.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

What are Notified Bodies?

A

Notified Body:

Certification organizations that are designated by Member States

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

What are the responsibilities of Notified Bodies?

A
  • Assessing manufacturers’ compliance with the requirements of the EU medical device law
  • Attesting to compliance by granting certificates
  • Monitoring compliance through periodic scheduled and unannounced audits
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

The nature of a Notified Body’s involvement depends on what?

A

The risk class of the device

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

What is the NBCG?

A

NBCG: Notified Body Coordination Group

A collective notified body organization, to share views and experience, ensure consistency, etc.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

What is TEAM-NB?

A

An association of notified bodies, update code of conduct, support regulations and guidelines, etc.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

What does it mean for notified bodies to have a self-regulatory code for MDD/AIMDD/IVD work?

A

The code (by TEAM-NB) aims to create a harmonized quality of work among notified bodies, to ensure the trustworthiness and address weaknesses of the notified body system

34
Q

What elements are included in the TEAM-NB code?

A
  • Qualification and assignment of NB personnel
  • Minimum time for NB assessments
  • Sampling of Class IIa/IIb technical files
  • Design dossier reviews
  • Unannounced visits (dun dun dun)
  • Rules for subcontracting
  • Rules for certification decisions
35
Q

What are the responsibilities of the EMA?

A

European Medicines Agency (EMA): Responsible for the scientific evaluation of medicines

36
Q

What are the 3 main European standardization organizations?

A
  1. CEN: European Committee for Standardization (general compliance and non-active medical devices)
  2. CENELEC: European Committee for Electrotechnical Standardization (electromedical devices)
  3. ETSI: European Telecommunications Standards Institute (information and communications technologies)
37
Q

What are the 2 main international standardization organizations?

A
  1. ISO: International Organization for Standardization

2. IEC: International Electrotechnical Commission

38
Q

What is the definition of an importer?

A

Importer:
Any natural or legal person established within the Community who places a product from a third country on the Community market

39
Q

What is the definition of a distributor?

A

Distributor:
Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a product available on the market, up until the point of putting into service

40
Q

TRUE/FALSE: Importers and distributors do not have any responsibilities under the EU MDR / EU IVDR.

A

FALSE

Importers/distributors are responsible for verifying that products they handle are in compliance with EU requirements

41
Q

TRUE/FALSE: Healthcare establishments do not have any responsibilities under the EU MDR / EU IVDR.

A

True

However, there are some requirements on in-house produced medical devices and IVDs

42
Q

What is the CAMD?

A

CAMD: National Competent Authorities for Medical Devices

- institutional cooperation and consensus building

43
Q

What are 3 main trade associations in Europe?

A
  1. MedTech Europe (all medical device technology)
  2. COCIR (health IT and imaging devices)
  3. EUROM (sub-group for medical devices)
44
Q

The EU medical devices directives (MDD, AIMDD, and IVDD) are supplemented by what?

A

Commission directives and decisions

45
Q

The EU medical devices regulations (MDR and IVDR) are supplemented by what?

A

Implementing acts, delegated acts, and guidance

46
Q

What are the components of the medical device definition?

A
  1. Instrument, software, material, etc.
  2. Has an intended purpose
  3. For humans
  4. Does not achieve principal purpose through pharmacological means - aka not a drug
  5. EU MDR: Products used to clean/disinfect/sterilize devices are not defined as a medical device
47
Q

What is the definition of intended purpose?

A

Intended purpose

The use for which the device is intended according to the data supplied by the manufacturer on the labelling and IFU

48
Q

MDD: What products are excluded from the MDD medical device scope?

A

Human blood / blood products
Cells/tissues of human origin
Cells/tissues of animal origin

49
Q

MDR: What products are excluded from the MDR medical device scope?

A 
IVDs
Medicines 
ATMPs 
Cosmetics 
Biological material 
Food 
Human blood / blood products 
Cells/tissues of human origin 
Cells/tissues of animal origin
50
Q

Situation: A medical device is manufactured utilizing animal tissue. Is this regulated as a medical device?

A

Yes

51
Q

What is the definition of an active medical device?

A

Active Medical Device:
Any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity

52
Q

What is the definition of an active implantable medical device?

A

Active Implantable Medical Device:
Any active medical device that is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure

53
Q

What is the definition of an In Vitro Diagnostic Medical Device?

A

IVD:
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, for the purpose of providing information:
- concerning a physiological or pathological state
- concerning a congenital abnormality
- to determine the safety and compatibility with potential recipients
- to monitor therapeutic measures

54
Q

What is the definition of a specimen receptacle?

A

Specimen receptacle: IVDs
Those devices, specifically intended by their manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination

55
Q

What is the definition of an accessory?

A

MDD Accessory:
An article whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device
MDR Accessory:
Or to specifically and directly assist the medical functionality of the medical device in terms of its intended purpose

56
Q

What is the definition of placing on the market?

A

Placing on the market:
The first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished

57
Q

What is the definition of putting into service?

A

Putting into service:
The stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose
(takes place at the moment of first use within the Community by the end user)

58
Q

What is the definition of a custom-made device?

A

Custom-made device:
Any device specifically made in accordance with the written prescription of a qualified medical professional, under the prescriber’s responsibility, specific design characteristics and intended for a particular patient’s sole use
(does not include mass-produced devices that are adapted to meet a physician’s requirements)

59
Q

What are the requirements for a custom-made device?

A
  1. No CE-mark
  2. Must comply with MDD ER’s and MDR GSPR’s
  3. Must be manufactured under a quality system
  4. Must maintain documentation
    (don’t have to meet the requirements for full conformity assessment)
60
Q

What are the requirements for devices intended for clinical investigation?

A
  1. No CE-mark
  2. Device access is controlled
  3. Device location is documented
    (don’t have to meet the requirements for full conformity assessment)
61
Q

What is the definition of a manufacturer?

A

Manufacturer:
The natural or legal person with responsibility for the design, manufacture, packaging, and labeling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person or on his behalf by a third party
(summary: the entity placing devices on the EU market under its own name)

62
Q

When does a manufacture need to appoint an Authorized Representative?

A

If the manufacturer does not have an EU presence / registered place of business in a Member State

63
Q

TRUE/FALSE: The below are also considered to be a manufacturer:
Individuals who assemble, package, process, fully refurbish, and/or labels one of more ready-made products and/or assigns an intended purpose to the device TO PLACE IT ON THE MARKET UNDER ITS OWN NAME.

A

TRUE

64
Q

What are some scenarios in the EU MDR where the market party is considered the manufacturer? (and thus has manufacturer’s responsibility)

A
  • Change the intended purpose of the device
  • Modifying a device already placed on the market - in such a way that compliance with applicable requirements may be affected
  • Reprocessing a single use device
  • ** Significantly changes the performance or safety characteristics or the intended purpose of the device ***
65
Q

What is the definition of an Authorized Representative?

A

Authorized Representative:
Any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the mfr’s obligations
(MDD Article 14, EU MDR Article 11)

66
Q

TRUE/FALSE: The Authorized Representative is not liable for devices placed on the market.

A

FALSE - The AR is jointly and severally liable for damage as a result of defect devices

67
Q

TRUE/FALSE: The Authorized Representative maintains an independent position.

A

TRUE - The AR is required to terminate the mandate and inform the NB and CA in case the manufacturer is not compliant.

68
Q

Under the EU MDR and EU IVDR, how will the legislation be updated?

A

Through delegated and implementing acts

69
Q

Under the MDD, IVD, and AIMDD, how was legislation updated?

A

Through additional legal documents, interpretative documents, and recommendations

70
Q

What is the CJEU, and what is its purpose?

A

CJEU: Court of Justice of the European Union

Provides the ultimate interpretation of European law

71
Q

What is the role of national courts?

A

May interpret national and European medical device law

72
Q

What are the different types of guidance provided by the Commission under the MDD?

A

Guidance (MEDDEV) documents, consensus statements, and informative documents

73
Q

What is the MDEG?

A

MDEG: Medical Devices Expert Group

Mission is the implementation of the medical device directives, adopt the MEDDEV guidances

74
Q

What is the NBOG?

A

NBOG: Notified Body Operations Group

Issues guidance on notified bodies, goal is to improve quality of NBs and have consistency among NBs

75
Q

What is the MDCG?

A

MDCG: Medical Devices Coordination Group

Includes the Commission and persons from the Member States CAs

76
Q

What are the responsibilities of the MDCG?

A
  1. Assess CA and NB applicant conformity assessments
  2. Advise the Commission
  3. Develop guidance
  4. Monitor technical progress, review adequacy of GSPRs
  5. Develop device standards, CS, and scientific guidelines
  6. Assist in coordination activities
  7. Provide advice
77
Q

TRUE/FALSE: Under the EU MDR/EU IVDR, the Commission has the ability to make decisions in conflicts of interpretation, after consulting the MDCG.

A

TRUE! This is new in the EU MDR/EU IVDR

78
Q

What does compliance with harmonized technical standards mean?

A

Represents a presumption of compliance with the corresponding directives’ requirements

79
Q

TRUE/FALSE: The EU Commission has enforcement powers regarding compliance with the medical devices regulations (but not directives).

A

FALSE - The Member States are responsible for enforcement, not the EU Commission.

80
Q

What is the purpose of the New and Emerging Technology Working Group?

A

To understand the impact of accelerating technology on the regulatory framework

81
Q

What is a summary of the timelines of EU MDD/MDR compliance?

A

May 26, 2017: EU MDR/EU IVDR went into force
May 26, 2021: EU MDR Deadline (grace period begins)
May 26, 2022: EU IVDR Deadline (grace period begins)
May 26, 2024: EU MDR Deadline

82
Q

What are the supply chain obligations in the EU?

A

To verify the device’s compliance, inform the CA of noncompliance, implement corrective action

EU Medical Device Regulations (15 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions