Medical Device Conformity Assessment Procedure (Ch. 13) Flashcards
What is the purpose of the conformity assessment procedure?
To prove and establish compliance with the provisions of the EU legislation
Who is responsible for ensuring that a product complies with the relevant EU legislation?
The manufacturer
What are general requirements of all medical devices, regardless of class?
- Meet essential requirements
- Evaluate clinical performance and any side effects
- Subject to vigilance system
- Be CE-marked
- Registered with the CA
- Registered in any other countries
For a device, what is the conformity assessment procedure based on?
The device’s potential risk
What are the elements used in conformity assessment procedures?
- The QMS
- PMS System
- Technical Documentation
- DofC
What are the conformity assessment routes under MDD?
MDD Article 11,
Annex II, III, IV, V, VI, and VII
What are the conformity assessment routes under MDR?
MDR Article 52,
Annex IX, X, and XI
What are the conformity assessment routes under IVDD?
Annex III, IV, V, VI, and VII
What are the conformity assessment routes under IVDR?
Annex IX, X, and XI
Under MDR, what are the conformity assessment options for Class I (R/M/S) devices?
Annex IX OR Annex XI (Part A)
Under MDR, what are the conformity assessment options for Class IIa devices?
Annex IX or Annex XI Part A or Annex XI Part B
Under MDR, what are the conformity assessment options for Class IIb devices?
Annex IX or Annex X + Annex XI Part A or Annex X + Annex XI Part B
Under MDR, what are the conformity assessment options for Class III devices?
Annex IX or Annex X + Annex XI Part A or Annex X + Annex XI Part B
What is MDR Conformity Assessment Annex IX?
MDR Annex IX: Conformity Assessment based on a Quality Management System and on Assessment of the Technical Documentation
What is MDR Conformity Assessment Annex X?
MDR Annex X: Conformity Assessment based on Type-Examination
