EU Overview Training
EU MDR Awareness Quiz
Test your knowledge on the EU Medical Device Regulation with our comprehensive quiz! This quiz is designed for individuals seeking to understand essential aspects of the EU MDR, covering key dates, classifications, and certification processes.
- 10 multiple-choice questions
- Immediate feedback on answers
- Improve your understanding of EU regulations
EU MDR takes effect on
May 25, 2020
May 26, 2020
May 27, 2020
May 28, 2020
CE marking only applies to medical devices
True
False
Which EU regulatory body is most like FDA
Competent Authority
Notified Body
Which is not a Classification in the EU
Class I
Class IIa
Class IIb
Class III
Class IV
Which is used in the EU
PMA
Tech File
Design Dossier
510(k)
Which is not a type of EU Certification
QMS Cert
Design Examination Cert
Full Quality Assurance System Cert
All are EU Certs
Manufaturing Sites are Audited each year by their Notified Body
True
False
Regulations and Directives are the same
False
True
How many chapters does EU MDR have
10
15
7
30
All devices must maintain State of the Art in EU MDR
Flase
True
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