EU MDR Roles and Responsibilities Quiz
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Questions and Answers

According to the Medical Device Regulation (EU) 2017/745, who is considered an economic operator?

  • Authorized Representative
  • Manufacturer (correct)
  • Importer
  • Distributor
  • Who is responsible for the regulatory compliance of medical devices according to Article 15 of the Medical Device Regulation (EU) 2017/745?

  • Person Responsible for Regulatory Compliance (PRRC) (correct)
  • Importer
  • Authorized Representative
  • Manufacturer
  • Which of the following is not considered an economic operator under the Medical Device Regulation (EU) 2017/745?

  • Importer
  • Notified Body (correct)
  • Authorized Representative
  • Manufacturer
  • Who can combine medical devices or procedure packs according to Article 22(1) of the Medical Device Regulation (EU) 2017/745?

    <p>Person referred to in Article 22(1)</p> Signup and view all the answers

    Who is responsible for sterilized systems or procedure packs according to Article 22(3) of the Medical Device Regulation (EU) 2017/745?

    <p>Person referred to in Article 22(3)</p> Signup and view all the answers

    Which of the following is considered a non-invasive medical device?

    <p>1234</p> Signup and view all the answers

    Which classification rule applies to a blood bag?

    <p>Class I</p> Signup and view all the answers

    What is the duration of use for a long-term medical device?

    <p>More than 30 days</p> Signup and view all the answers

    Which conformity assessment process requires partial notified body certification?

    <p>Self Certification</p> Signup and view all the answers

    Which classification applies to a sterile, reprocessed medical device with a measuring function and high risk?

    <p>Class III</p> Signup and view all the answers

    Study Notes

    Economic Operators

    • According to the Medical Device Regulation (EU) 2017/745, an economic operator is a manufacturer, authorized representative, importer, or distributor.

    Regulatory Compliance

    • The manufacturer is responsible for the regulatory compliance of medical devices according to Article 15 of the Medical Device Regulation (EU) 2017/745.

    Non-Economic Operators

    • A healthcare professional or a patient is not considered an economic operator under the Medical Device Regulation (EU) 2017/745.

    Combination of Medical Devices

    • A manufacturer, authorized representative, or importer can combine medical devices or procedure packs according to Article 22(1) of the Medical Device Regulation (EU) 2017/745.

    Sterilized Systems or Procedure Packs

    • The manufacturer is responsible for sterilized systems or procedure packs according to Article 22(3) of the Medical Device Regulation (EU) 2017/745.

    Non-Invasive Medical Devices

    • A portable defibrillator is considered a non-invasive medical device.

    Classification of Blood Bags

    • Rule 8 applies to the classification of a blood bag.

    Duration of Use

    • A long-term medical device has a duration of use more than 30 days.

    Conformity Assessment

    • The self-certification process requires partial notified body certification.

    Classification of Sterile, Reprocessed Medical Devices

    • A sterile, reprocessed medical device with a measuring function and high risk is classified as Class IIb.

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    Description

    Test your knowledge on the roles and responsibilities of economic operators in the EU Medical Device Regulation (EU MDR) 2017/745. This quiz will cover topics such as manufacturers, authorized representatives, importers, and distributors. Get ready to dive into Article 2 Systems and Procedure Packs and enhance your understanding of EU MDR requirements.

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