Medical Device Regulations in Europe
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Questions and Answers

What is the purpose of a quality management system (QMS) in the context of medical device regulation?

  • To simplify the regulatory process for medical devices
  • To ensure consistent meeting of customer requirements and satisfaction (correct)
  • To speed up the approval process for new medical devices
  • To maximize profits for the manufacturers

    • Which product falls under Class IIb as per the classification of medical devices in Europe?

  • Pacemakers (correct)
  • CT machine
  • Wheelchair
  • Surgical clamps

    • What is the purpose of a Declaration of Conformity in the context of medical device regulation?

  • To request financial support for medical device production
  • To declare the intention to manufacture a new medical device
  • To seek approval for marketing a medical device
  • To declare conformity with the essential requirements and standards (correct)

    • What does MDR Annex IX primarily focus on?

    <p>Definition of regulatory strategy and conformity assessment procedures</p> Signup and view all the answers

    In the context of medical device regulation in Europe, what is the role of a Notified Body?

    <p>To assess and approve technical documentation for medical devices</p> Signup and view all the answers

    What is one of the main aspects of the quality management system according to DIN EN ISO 13485?

    <p>Documentation of design evolution</p> Signup and view all the answers

    In the context of the regulation of artificial organs in Europe, what is required for customer related requirements (URS)?

    <p>Controlled purchasing with verification of purchased articles and supplier</p> Signup and view all the answers

    According to the Medical Device Regulation (MDR) 2017/745, what is included in the technical documentation?

    <p>Documentation of design and development file for each product</p> Signup and view all the answers

    What is one of the aspects covered in the declaration of conformity for artificial organs in Europe?

    <p>Product definition &amp; classification</p> Signup and view all the answers

    What is a requirement for the verification and validation process according to the European Medical Device Regulation MDR 2017/745?

    <p>Documentation of design reviews and decision</p> Signup and view all the answers

    What is the purpose of the Test according to the given text?

    <p>To reveal the ink flow of the pen</p> Signup and view all the answers

    In the context of the Quality Management System DIN EN ISO 13485, what is the main aspect mentioned in the given text?

    <p>Plan and document development</p> Signup and view all the answers

    What does DRS stand for in the given text?

    <p>Design Requirement Specification</p> Signup and view all the answers

    According to the given text, what does URS refer to?

    <p>Customer related requirements</p> Signup and view all the answers

    What is the main difference between MDR and MDD in terms of conformity assessment?

    <p>MDR requires all medical products to be recertified, while MDD does not have this requirement.</p> Signup and view all the answers

    What is the validation test mentioned in the text?

    <p>Test reveals ink flow is 107 +/- 4 mg/km</p> Signup and view all the answers

    Which chapter of the MDR 2017/745 focuses on the classification and conformity of medical devices?

    <p>Chapter 5: Classification &amp; Conformity</p> Signup and view all the answers

    What is the purpose of Annex III in the MDR 2017/745?

    <p>Post-market surveillance</p> Signup and view all the answers

    What action must a manufacturer take before placing a medical product on the market according to the MDR?

    <p>Submit a declaration of conformity to a Notified Body</p> Signup and view all the answers

    What is the main difference between MDR and MPDG in relation to medical device regulation?

    <p>MDR replaces MPDG and introduces a transition period, while MPDG does not have a transition period.</p> Signup and view all the answers

    Which authority is responsible for the surveillance of medical products on the market in Germany?

    <p>Bundesinstitut für Arzneimittel und Medizinprodukte</p> Signup and view all the answers

    How many Notified Bodies are currently certified for Medical Device Regulation (MDR) in Europe?

    <p>36</p> Signup and view all the answers

    What is the role of ZLG (Zentralstelle der Länder für Gesundheitsschutz) in Germany?

    <p>Certification and monitoring of Notified Bodies</p> Signup and view all the answers

    Which annex of the Medical Device Regulation (MDR) primarily focuses on clinical investigation?

    <p>Annex XV</p> Signup and view all the answers

    In the context of medical device regulation, what does the term 'Custom-made devices' refer to?

    <p>Devices made specifically for individual patients</p> Signup and view all the answers

    What is the main focus of the Medical Device Regulation (MDR) in Europe?

    <p>Regulating medical devices and accessories for human use</p> Signup and view all the answers

    What does the Medical Device Regulation (MDR) replace?

    <p>Medical Device Directive (MDD)</p> Signup and view all the answers

    Which of the following is NOT covered by the Medical Device Regulation (MDR) in Europe?

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

    What is the transition period for compliance with the Medical Device Regulation (MDR) in Europe?

    <p>Till 05/2024</p> Signup and view all the answers

    Which entities need to be recertified according to the Medical Device Regulation (MDR)?

    <p>Both medical products and notified bodies</p> Signup and view all the answers

    What must be included in the documented quality policy according to the text?

    <p>Quality objectives and documented quality policy</p> Signup and view all the answers

    What is a required documentation for the Quality Management System (QMS) as per the text?

    <p>Documents and Records of all processes needed to maintain and improve the QMS</p> Signup and view all the answers

    In the context of medical device regulation, which chapter discusses the Definition of Quality Police and commitment?

    <p>Chapter 5</p> Signup and view all the answers

    What is a requirement for the documented quality policy according to the text?

    <p>Quality objectives and documented quality policy</p> Signup and view all the answers

    Which type of documents must be included in the documentation of the QMS according to the text?

    <p>Documents and records of all processes needed to maintain and improve the QMS</p> Signup and view all the answers

    What is a requirement for the Quality Management System (QMS) documentation as per the text?

    <p>Documents and Records of all required processes</p> Signup and view all the answers

    Which chapter in the text discusses Documented quality policy and quality objectives?

    <p>Chapter 4</p> Signup and view all the answers

    What should be included in the Documentation of the QMS according to the text?

    <p>Quality manual and list of all processes needed to maintain and improve the QMS</p> Signup and view all the answers

    Which documents are required for maintaining and improving the Quality Management System (QMS) as per the text?

    <p>Quality manual and records of all processes needed to maintain and improve the QMS</p> Signup and view all the answers

    Which chapter discusses Documents and Records of all required processes according to the text?

    <p>Chapter 4</p> Signup and view all the answers

    What must be included in the documentation of the Quality Management System (QMS) according to DIN EN ISO 13485?

    <p>Records of all processes needed to maintain and improve the QMS</p> Signup and view all the answers

    Which chapter of DIN EN ISO 13485 focuses on the definition of Quality Policy and commitment?

    <p>Chapter 5</p> Signup and view all the answers

    What is the main aspect covered in Chapter 4 of the Quality Management System DIN EN ISO 13485?

    <p>Documentation of the QMS</p> Signup and view all the answers

    What does DIN EN ISO 13485 primarily focus on?

    <p>Requirements for quality management systems in the medical device industry</p> Signup and view all the answers

    In the context of medical device regulation, what is the purpose of Chapter 5 of DIN EN ISO 13485?

    <p>Outlining the documentation needed for maintaining and improving the QMS</p> Signup and view all the answers

    Which standard governs the requirements for regulatory purposes in Europe as per the given text?

    <p>DIN EN ISO 13485:2016</p> Signup and view all the answers

    What is NOT a part of the documentation required for the Quality Management System (QMS) according to DIN EN ISO 13485?

    <p>Clinical trial reports</p> Signup and view all the answers

    According to DIN EN ISO 13485, what is one of the main aspects that must be included in the QMS documentation?

    <p>Records of all processes needed to maintain and improve the QMS</p> Signup and view all the answers

    What must be included in the documented quality policy and quality objectives as per the given text?

    <p>Records of customer complaints</p> Signup and view all the answers

    What does Chapter 5 of DIN EN ISO 13485 primarily focus on?

    <p>Documentation required for maintaining and improving the QMS</p> Signup and view all the answers

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