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EU Medical Device Regulations > Medical Device Conformity Assessment Procedure (Ch. 13) > Flashcards

Medical Device Conformity Assessment Procedure (Ch. 13) Flashcards

1
Q

What is the purpose of the conformity assessment procedure?

A

To prove and establish compliance with the provisions of the EU legislation

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2
Q

Who is responsible for ensuring that a product complies with the relevant EU legislation?

A

The manufacturer

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3
Q

What are general requirements of all medical devices, regardless of class?

A
  1. Meet essential requirements
  2. Evaluate clinical performance and any side effects
  3. Subject to vigilance system
  4. Be CE-marked
  5. Registered with the CA
  6. Registered in any other countries
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4
Q

For a device, what is the conformity assessment procedure based on?

A

The device’s potential risk

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5
Q

What are the elements used in conformity assessment procedures?

A
  1. The QMS
  2. PMS System
  3. Technical Documentation
  4. DofC
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6
Q

What are the conformity assessment routes under MDD?

A

MDD Article 11,

Annex II, III, IV, V, VI, and VII

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7
Q

What are the conformity assessment routes under MDR?

A

MDR Article 52,

Annex IX, X, and XI

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8
Q

What are the conformity assessment routes under IVDD?

A

Annex III, IV, V, VI, and VII

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9
Q

What are the conformity assessment routes under IVDR?

A

Annex IX, X, and XI

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10
Q

Under MDR, what are the conformity assessment options for Class I (R/M/S) devices?

A

Annex IX OR Annex XI (Part A)

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11
Q

Under MDR, what are the conformity assessment options for Class IIa devices?

A

Annex IX or Annex XI Part A or Annex XI Part B

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12
Q

Under MDR, what are the conformity assessment options for Class IIb devices?

A

Annex IX or Annex X + Annex XI Part A or Annex X + Annex XI Part B

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13
Q

Under MDR, what are the conformity assessment options for Class III devices?

A

Annex IX or Annex X + Annex XI Part A or Annex X + Annex XI Part B

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14
Q

What is MDR Conformity Assessment Annex IX?

A

MDR Annex IX: Conformity Assessment based on a Quality Management System and on Assessment of the Technical Documentation

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15
Q

What is MDR Conformity Assessment Annex X?

A

MDR Annex X: Conformity Assessment based on Type-Examination

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16
Q

What is MDR Conformity Assessment Annex XI?

A

MDR Annex XI: Conformity Assessment Based on Product Conformity Verification

17
Q

What are the two parts of MDR Annex XI?

A

Part A: Production Quality Assurance

Part B: Product Verification

18
Q

What is MDR Annex XIII?

A

Procedure for Custom-Made Devices

EU Medical Device Regulations (15 decks)

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