GMP for medical devices and IVDs MCQs With Answer

Introduction: GMP for medical devices and IVDs MCQs With Answer is designed for M.Pharm students to reinforce advanced regulatory knowledge and practical GMP expectations specific to medical devices and in vitro diagnostics. This set of focused multiple-choice questions covers quality management systems, risk management, design controls, sterilization and validation standards, traceability (UDI), post-market surveillance, supplier qualification, software and laboratory controls, and IVD-specific performance requirements. Each question encourages critical thinking about compliance, documentation (DMR/DHR), CAPA, change control, and clinical/evidence requirements. Use these MCQs to prepare for exams, practical regulatory work, or audits where detailed GMP understanding is essential.

Q1. Which standard is the internationally recognized quality management system specifically for medical devices and IVD manufacturers?

• ISO 9001:2015
• ISO 13485:2016
• 21 CFR Part 210
• Good Laboratory Practice (GLP)

Correct Answer: ISO 13485:2016

Q2. Which standard provides the framework for risk management throughout the lifecycle of a medical device including IVDs?

• ISO 14971
• IEC 60601
• ISO 9000
• ISO 15189

Correct Answer: ISO 14971

Q3. In the context of design control, what best describes the difference between verification and validation?

• Verification confirms the device meets user needs; validation checks documented design outputs against inputs
• Verification checks design outputs against design inputs; validation confirms the device meets user needs and intended use
• Verification is regulatory submission; validation is stability testing
• Verification is clinical testing; validation is bench testing

Correct Answer: Verification checks design outputs against design inputs; validation confirms the device meets user needs and intended use

Q4. Which document contains the detailed manufacturing specifications, procedures, and quality specifications for a device (commonly used term in GMP for devices)?

• Design History File (DHF)
• Device History Record (DHR)
• Device Master Record (DMR)
• Technical File

Correct Answer: Device Master Record (DMR)

Q5. What does DHR stand for and what is its primary purpose?

• Device History Record; to document the production history and show that each unit was produced according to the DMR
• Design History Record; to capture design inputs and outputs
• Device Handling Report; to log distribution events
• Documented Hazard Report; to list known risks

Correct Answer: Device History Record; to document the production history and show that each unit was produced according to the DMR

Q6. What is the primary purpose of the Unique Device Identification (UDI) system?

• Standardize batch numbering across suppliers
• Enhance traceability and support post-market surveillance and recalls
• Replace CE marking
• Provide shipping logistics codes

Correct Answer: Enhance traceability and support post-market surveillance and recalls

Q7. Which ISO standard specifically addresses moist heat (steam) sterilization validation for medical devices?

• ISO 11135
• ISO 11137
• ISO 17665
• ISO 11737

Correct Answer: ISO 17665

Q8. Which standard is used for validation of ethylene oxide (EO) sterilization processes?

• ISO 11137
• ISO 11135
• ISO 14971
• ISO 13485

Correct Answer: ISO 11135

Q9. For IVD reagent stability and shelf-life determination, which approach is considered most relevant to demonstrate real-world performance?

• Only accelerated stability studies at elevated temperature
• Real-time stability studies under labeled storage conditions combined with periodic performance testing
• Single time-point testing at end of shelf life
• In-silico predictions without wet-lab confirmation

Correct Answer: Real-time stability studies under labeled storage conditions combined with periodic performance testing

Q10. Which parameter is typically considered separate from routine bioburden testing for sterile medical devices?

• Total aerobic microbial count
• Fungal count
• Endotoxin testing (LAL)
• Total viable count

Correct Answer: Endotoxin testing (LAL)

Q11. Which standard governs medical device software lifecycle processes including risk management for software?

• IEC 62304
• ISO 14971
• IEC 60601
• ISO 13485

Correct Answer: IEC 62304

Q12. Which EU regulation introduced more rigorous requirements for in vitro diagnostic devices, including classification changes and stronger performance evidence?

• Medical Device Directive (MDD) 93/42/EEC
• IVDR (Regulation (EU) 2017/746)
• MDR (Regulation (EU) 2017/745)
• CE Marking Directive 2000/9/EC

Correct Answer: IVDR (Regulation (EU) 2017/746)

Q13. The primary objective of a CAPA (Corrective and Preventive Action) system is to:

• Replace normal quality control testing
• Record production deviations without follow-up
• Identify root causes and implement actions to prevent recurrence and recurrence of nonconformities
• Automate labeling changes

Correct Answer: Identify root causes and implement actions to prevent recurrence and recurrence of nonconformities

Q14. Which statement best characterizes an in vitro diagnostic (IVD) device compared with other medical devices?

• An IVD is intended to be implanted into the human body
• An IVD provides diagnostic information by examining specimens taken from the human body, rather than acting directly on the body
• An IVD always contains a pharmaceutical active ingredient
• An IVD is exclusively for therapeutic use

Correct Answer: An IVD provides diagnostic information by examining specimens taken from the human body, rather than acting directly on the body

Q15. Which element is essential to include on the labeling of an IVD kit according to GMP and regulatory expectations?

• Intended use and performance characteristics
• Only the manufacturer’s logo
• Internal lab protocol steps not for users
• Distributor pricing information

Correct Answer: Intended use and performance characteristics

Q16. A Post-Market Surveillance (PMS) plan for a medical device or IVD should at minimum describe:

• How the company will handle only manufacturing releases
• Procedures for vigilance, complaint handling, data collection for performance and safety, and periodic evaluation
• Only marketing strategies and sales targets
• How to bypass notified body oversight

Correct Answer: Procedures for vigilance, complaint handling, data collection for performance and safety, and periodic evaluation

Q17. For reusable surgical instruments, which cleaning validation endpoint is commonly measured to assess effective decontamination?

• Protein residue level (e.g., PR test)
• Color matching of the instrument finish
• Electrical conductivity
• Packaging tensile strength

Correct Answer: Protein residue level (e.g., PR test)

Q18. Which analytical performance metric describes the lowest concentration of an analyte that an IVD can reliably detect?

• Limit of Detection (LoD)
• Limit of Quantitation (LoQ)
• Linearity Range
• Precision

Correct Answer: Limit of Detection (LoD)

Q19. A manufacturer identifies a manufacturing change that could affect device performance and safety. Under GMP and regulatory practice, this change should be classified and typically will require:

• No documentation if routine
• Revalidation and, if significant, regulatory notification or submission prior to implementation
• Only a note in the supplier file
• Immediate market withdrawal without assessment

Correct Answer: Revalidation and, if significant, regulatory notification or submission prior to implementation

Q20. Which activities are core elements of supplier qualification for critical components used in medical devices and IVDs?

• Initial supplier assessment, on-site audit, quality agreement, incoming inspection and ongoing performance monitoring
• Accept verbal assurances without records
• Only review commercial pricing
• Onboard suppliers without any incoming QC testing

Correct Answer: Initial supplier assessment, on-site audit, quality agreement, incoming inspection and ongoing performance monitoring

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