Medical device regulation basics MCQs With Answer

Medical Device Regulation Basics MCQs With Answer helps M. Pharm (Regulatory Affairs) students test and strengthen their understanding of core global frameworks governing medical devices. This quiz covers the essentials across the U.S., EU, and India: device classification, premarket pathways, conformity assessment, quality systems, risk management, clinical evaluation, UDI, and postmarket surveillance. You will encounter questions on FDA pathways (510(k), PMA, De Novo, IDE), EU MDR concepts (CE marking, Notified Bodies, GSPR, Rule 11 for software), ISO standards (13485, 14971), and India’s CDSCO risk-based approach (Classes A–D). Each item emphasizes practical regulatory reasoning useful for dossier strategy, compliance by design, and lifecycle vigilance. Review the explanations by cross-checking the correct options.

Q1. What is the primary purpose of medical device regulation?

• To maximize market share irrespective of risks
• To ensure devices are safe, perform as intended, and meet quality standards throughout their lifecycle
• To protect manufacturer intellectual property
• To reduce manufacturing costs through deregulation

Correct Answer: To ensure devices are safe, perform as intended, and meet quality standards throughout their lifecycle

Q2. Which authority is primarily responsible for regulating medical devices in the United States?

• European Medicines Agency (EMA)
• FDA’s Center for Drug Evaluation and Research (CDER)
• FDA’s Center for Devices and Radiological Health (CDRH)
• U.S. Patent and Trademark Office (USPTO)

Correct Answer: FDA’s Center for Devices and Radiological Health (CDRH)

Q3. Which framework currently governs medical devices in the European Union, replacing the MDD 93/42/EEC?

• EU Medical Device Regulation (MDR) 2017/745
• EU In Vitro Diagnostic Regulation (IVDR) 2017/746
• 21 CFR Part 820 (QSR)
• ISO 13485:2016

Correct Answer: EU Medical Device Regulation (MDR) 2017/745

Q4. How are medical devices classified under India’s Medical Devices Rules (MDR) 2017?

• Class I (low) to Class III (high) risk
• Classes A, B, C, D (low to high risk)
• Classes X, Y, Z (increasing risk)
• No risk-based classification is used

Correct Answer: Classes A, B, C, D (low to high risk)

Q5. Which U.S. premarket pathway is most commonly used for moderate-risk (many Class II) devices?

• Biologics License Application (BLA)
• 510(k) premarket notification
• Premarket Approval (PMA)
• Abbreviated New Drug Application (ANDA)

Correct Answer: 510(k) premarket notification

Q6. Which statement best describes Premarket Approval (PMA) in the U.S.?

• A notification proving substantial equivalence to a predicate device
• A streamlined pathway for low-risk devices
• The most stringent review requiring valid scientific evidence for Class III devices
• An exemption for investigational devices

Correct Answer: The most stringent review requiring valid scientific evidence for Class III devices

Q7. When is the De Novo classification pathway appropriate in the U.S.?

• For high-risk implantable devices with extensive clinical data
• For novel, low-to-moderate risk devices without a legally marketed predicate
• For software updates to an already cleared device
• For exempt Class I devices entering the market

Correct Answer: For novel, low-to-moderate risk devices without a legally marketed predicate

Q8. What does CE marking signify for a medical device under EU MDR?

• Approval for global sales without additional requirements
• Conformity with EU General Safety and Performance Requirements and eligibility for EEA market access
• Evidence of therapeutic equivalence to a reference device
• Compliance with U.S. FDA labeling rules

Correct Answer: Conformity with EU General Safety and Performance Requirements and eligibility for EEA market access

Q9. What is the role of Notified Bodies (NBs) under EU MDR 2017/745?

• They set EU legislation and issue guidance documents
• They perform independent conformity assessments and issue EU MDR certificates
• They handle postmarket surveillance for all devices
• They approve clinical trial protocols across the EU

Correct Answer: They perform independent conformity assessments and issue EU MDR certificates

Q10. What is the primary purpose of the Unique Device Identification (UDI) system?

• To standardize packaging sizes
• To improve device traceability, facilitate recalls, and strengthen postmarket surveillance
• To classify devices into risk categories
• To replace clinical evaluation requirements

Correct Answer: To improve device traceability, facilitate recalls, and strengthen postmarket surveillance

Q11. Under FDA Quality System Regulation (21 CFR 820), which file documents the design history and its evolution?

• Device Master Record (DMR)
• Device History Record (DHR)
• Design History File (DHF)
• Management Review Minutes

Correct Answer: Design History File (DHF)

Q12. Which regulation covers mandatory postmarket adverse event reporting by manufacturers to the U.S. FDA?

• 21 CFR Part 820
• 21 CFR Part 803
• 21 CFR Part 11
• 21 CFR Part 806

Correct Answer: 21 CFR Part 803

Q13. Which standard specifies a quality management system tailored to medical devices?

• ISO 9001
• ISO 13485
• ISO 14971
• ISO 10993

Correct Answer: ISO 13485

Q14. ISO 14971 is primarily concerned with which aspect of medical devices?

• Biocompatibility testing
• Sterilization validation
• Risk management throughout the product lifecycle
• Clinical investigation design

Correct Answer: Risk management throughout the product lifecycle

Q15. Under EU MDR, clinical evaluation must demonstrate which of the following?

• Only analytical performance using bench tests
• Clinical safety and performance using clinical data, documented in a Clinical Evaluation Report (CER)
• Only non-clinical biocompatibility per ISO 10993
• That the device is cheaper than competitors

Correct Answer: Clinical safety and performance using clinical data, documented in a Clinical Evaluation Report (CER)

Q16. Which is India’s national regulatory authority responsible for medical devices oversight?

• Food Safety and Standards Authority of India (FSSAI)
• Central Drugs Standard Control Organization (CDSCO)
• Indian Council of Medical Research (ICMR)
• Pharmacy Council of India (PCI)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q17. Which record demonstrates that each lot/batch/unit was manufactured and released according to the DMR?

• Design History File (DHF)
• Device Master Record (DMR)
• Device History Record (DHR)
• Risk Management Report

Correct Answer: Device History Record (DHR)

Q18. Which mechanism permits clinical investigation of a significant risk device in the United States?

• Investigational New Drug (IND)
• Investigational Device Exemption (IDE)
• 510(k) premarket notification
• CE conformity assessment

Correct Answer: Investigational Device Exemption (IDE)

Q19. In EU MDR, the old “Essential Requirements” terminology has been replaced by which term?

• Special Controls
• General Safety and Performance Requirements (GSPR)
• Fundamental Conformity Clauses
• Core Harmonized Directives

Correct Answer: General Safety and Performance Requirements (GSPR)

Q20. Under EU MDR Annex VIII, which rule frequently governs classification of Software as a Medical Device (SaMD)?

• Rule 1
• Rule 11
• Rule 21
• Rule 5

Correct Answer: Rule 11

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