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EU Medical Device Regulations > History of Regulations (Ch. 2) > Flashcards

History of Regulations (Ch. 2) Flashcards

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USMLE® Step 1 flashcards
1
Q

When was the EU formed?

A

1957: EEU - European Economic Union was formed to create a single European market to allow people, products, and services to move freely
Renamed to the EU in 1992

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2
Q

What is the benefit of harmonized legislation?

A

No conflicting requirements, and all countries are in agreement

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3
Q

What is the structure of EU legislation (primary, secondary, etc.)?

A

Primary Legislation: EU Treaty
Secondary Legislation: Directives and regulations, decisions, opinions, and recommendations
Other: Guidances (MEDDEVs), harmonized standards,

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4
Q

What is a directive?

A

Directive: obliges Member States to implement its provisions into National Laws

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5
Q

What is a regulation?

A

Regulation: directly applicable in all Member States, and obliges Member States to remove any conflicting provisions from national legislation

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6
Q

What is the EU MDR regulation?

A

EU Medical Devices Regulation (EU MDR):

Regulation (EU) 2017/745

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7
Q

What is the EU IVDR regulation?

A

EU In Vitro Diagnostics Regulation (EU IVDR):

Regulation (EU) 2017/746

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8
Q

What are EPARs?

A

EPAR: European Public Assessment Reports

- contain detailed info on the approval/rejection of a product

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9
Q

What are NPARs?

A

NPAR: National Public Assessment Reports

- contain approval/rejection info on a national level

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10
Q

TRUE/FALSE: Patient involvement and representation in the regulatory process is increasing.

A

True

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11
Q

What is the purpose of the Transparency Directive (Council Directive 1989/105/EEC)?

A 
Transparency Directive (Council Directive 1989/105/EEC): 
Includes minimum procedural safeguards ensuring national cost-containment measures regulating the pricing of medicines were transparent
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12
Q

What is the BeNeLuxA Initiative?

A

BeNeLuxA Initiative:

Collaboration on pharmaceutical pricing

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13
Q

What is the purpose of the Falsified Medicines Directive (FMD, Directive 2011/62/EU)?

A

Falsified Medicines Directive (FMD, Directive 2011/62/EU):

- To prevent the distribution of falsified medical products, includes authenticity features

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14
Q

What are the two types of harmonized product legislation?

A
  1. The Traditional Approach

2. The New Approach

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15
Q

What is the Traditional Approach?

A

Traditional Approach:

Implies the inclusion of detailed technical specifications in the law - highly detailed, extensive laws

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16
Q

What is the New Approach?

A

New Approach:
Includes Essential Requirements for safety and performance in the core legal text, and publishing the technical specification in harmonized standards - reduces regulatory burden, increases development
(introduced in the 1980’s)

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17
Q

Pharmaceutical and medical device regulations are based on what principle?

A

A positive balance between benefit and risk principle

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18
Q

What is the first European Medicinal Products Directive?

A

Council Directive 65/65/EEC

- detailed requirements for medicinal products for human use and MA requirements

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19
Q

What is the Centralized Procedure?

A

Centralized Procedure:

Enables a single medicinal product MA for the entire EU

20
Q

What is the National Procedure?

A

National Procedure:
For medicinal products that are not qualified for centralized approval, and are intended for marketing in only one EU Member State

21
Q

What is the process for the Mutual Recognition Procedure and the Decentralized Procedure?

A

The MAA is evaluated by one Member State (Reference Member State: RMA), and the evaluation is recognized by other Member States

22
Q

When do the Mutual Recognition Procedure and the Decentralized Procedure apply?

A

Mutual Recognition Procedure: Applies if the applicant already has an MA in one EU Member State
Decentralized Procedure: Applies if the applicant seeks simultaneous authorization in more than one Member State

23
Q

Directive 2001/83/EEC was an act of codification, what were the benefits of this?

A

Codification combined the contents of all previous directives and simplified, unified, and clarified all regulatory requirements

24
Q

What is the purpose of the Variations Directive, Commission Regulation (EC) No. 1234/2008?

A

Variations Directive, Commission Regulation (EU) No. 1234/2008:
To address variations/extensions to marketing authorizations

25
Q

What are biologics?

A

Vaccines, blood derivatives, allergens, somatic cells, gene therapies, and tissue proteins

26
Q

What is the VAMF?

A

VAMF: Vaccine Antigen Master File

- allows a single evaluation of a vaccine antigen

27
Q

What is the BWP?

A

BWP: Biologics Working Party

- Provides recommendations on all matters related to biological and biotechnical medicines

28
Q

What is the purpose of the Regulation (EC) No. 1394/2007 (ATMPs)?

A

Regulation (EC) No. 1394/2007:
Included ATMPs in the pharmaceutical regulation
(ATMP: Advanced Therapy Medicinal Products)

29
Q

What is the purpose of the Directive 2004/27/EC (biosimilars)?

A

Directive 2004/27/EC:

Added requirements for an MAA based on the demonstration of similarity of two biological medicinal products

30
Q

What two areas do veterinary regulations cover?

A
  1. Veterinary medicines’ quality, safety, and efficacy (mirror human medicines)
  2. Safety of residues in treated animals’ foodstuffs
31
Q

What is the purpose of Directive 2004/24/EC (herbal products)?

A

Directive 2004/24/EC:

Established a simplified application for traditional herbal medicinal products

32
Q

What is the CE mark?

A 
Conformite Europeenne (CE), or European Conformity Mark 
Indicates the product complies with all applicable EU legislation and can be considered the "passport" to the EU single market
33
Q

What is the difference between Essential Requirements and technical requirements?

A

Essential Requirements for safety and performance: included in the legal texts
Technical specifications and requirements: Described in standards

34
Q

What is standardization?

A

Standardization:

The process of drafting standards and then the standard being approved by a recognized standardization body

35
Q

What is a harmonized standard?

A
  • A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI
  • Can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.
36
Q

Where does the Commission publish harmonized standards?

A

The Official Journal

37
Q

What is the Blue Guide?

A

Blue Guide:
A guide to the implementation of directives based on the New Approach and the Global Approach
(has a blue cover)

38
Q

What is presumption of conformity (as relates to harmonized standards)?

A

Presumption of conformity:
means that if the product complies to the harmonized standard, the product is presumed by the Member States to be in conformity with the Essential Requirements

39
Q

What is the core legal framework for medical devices?

A

Council Directive 90/385/EEC: AIMDD (Active Implantable Medical Devices)
Council Directive 93/42/EEC: MDD (Medical Devices Directive)
Directive 98/79/EC: IVDD (In Vitro Diagnostics Medical Devices Directive)

40
Q

What are the key elements of the MDD?

A
  • Conformity assessment procedure routes
  • Classification Rules based on risk
  • Notified body approval / CE-mark
41
Q

What are the 4 classes of medical devices?

A

Class I: low-risk
Class IIa and IIb: medium-risk
Class III: high-risk

42
Q

What are Notified Bodies?

A

Notified Bodies:
Private organizations with special legal status that are designated by national competent authorities to check manufactures’ conformity assessment procedures and grant certificates according to the requirements

43
Q

What is Directive 2007/47/EC?

A

Directive 2007/47/EC:
Amended 93/42/EEC and 90/385/EEC, included software, added checks of representative samples of design dossiers by notified bodies, and extended clinical evaluation obligations

44
Q

What are IVDs?

A

IVD: In Vitro Diagnostic Medical Device
Reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems to be used for the in vitro examination of human samples to make a medical diagnosis

45
Q

True/False: The MDD and IVDD classification systems are rule based.

A

False - The IVDD classification system is not rule-based, but instead includes a list of regulated products. (To be updated in the IVDR)

EU Medical Device Regulations (15 decks)

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