EU device regulation: MDD/AIMDD/IVDD to MDR/IVDR and CE marking MCQs With Answer

Introduction:

This quiz set focuses on the transition from the old EU directives (MDD, AIMDD, IVDD) to the newer Regulations (MDR 2017/745 and IVDR 2017/746) and key aspects of CE marking. It is designed for M. Pharm students studying Regulatory Aspects of Medical Devices to deepen understanding of classification, conformity assessment routes, clinical evidence requirements, post-market vigilance, UDI and documentation obligations under the Regulations. Questions emphasize practical regulatory changes, responsibilities (including Notified Bodies and PRRC), and essentials of technical documentation and post-market surveillance to prepare students for regulatory roles in medical device development, compliance and quality assurance.

Q1. Which legal instruments replaced the Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD) and In Vitro Diagnostic Directive (IVDD) in the EU?

• Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
• Directive (EU) 2017/745 (MDR) and Directive (EU) 2017/746 (IVDR)
• Regulation (EU) 2017/745 (MDR) only; IVDD remains in force
• Directive 93/42/EEC and Directive 98/79/EC remain applicable

Correct Answer: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)

Q2. Under the MDR, how are medical devices classified by risk?

• Classes I, IIa, IIb and III (risk-based ascending order)
• Classes A, B, C and D (alphabetical order)
• Low, Medium and High only
• Class I only for all devices

Correct Answer: Classes I, IIa, IIb and III (risk-based ascending order)

Q3. Which device classes generally require Notified Body involvement for conformity assessment under the MDR?

• Class IIa, Class IIb and Class III devices
• Only Class I devices
• All devices including Class I non‑sterile, non‑measuring
• Only in vitro diagnostics

Correct Answer: Class IIa, Class IIb and Class III devices

Q4. What does the CE marking indicate on a medical device placed on the EU market?

• The device conforms to applicable EU legislation and essential safety and performance requirements
• The device is manufactured only in the EU
• The device is approved by the European Parliament
• The device is exempt from post-market surveillance

Correct Answer: The device conforms to applicable EU legislation and essential safety and performance requirements

Q5. Which primary document demonstrates that a device meets the MDR general safety and performance requirements?

• Technical documentation (technical file) including design, risk, clinical and conformity evidence
• Only the user manual
• Marketing materials and brochures
• Packaging artwork

Correct Answer: Technical documentation (technical file) including design, risk, clinical and conformity evidence

Q6. The MDR introduced the role of Person Responsible for Regulatory Compliance (PRRC). Which statement best describes this role?

• An employed or contracted qualified person who ensures conformity of devices and regulatory compliance obligations are met
• A marketing manager who promotes CE marked devices
• An external auditor who inspects manufacturing sites yearly
• A Notified Body reviewer who signs Declarations of Conformity

Correct Answer: An employed or contracted qualified person who ensures conformity of devices and regulatory compliance obligations are met

Q7. What is the primary purpose of Eudamed under the MDR/IVDR?

• To provide a centralized EU database for device registration, certificates, vigilance and market surveillance information
• To replace national competent authorities in member states
• To act as a commercial marketplace for devices
• To issue CE certificates directly to manufacturers

Correct Answer: To provide a centralized EU database for device registration, certificates, vigilance and market surveillance information

Q8. Why was a Unique Device Identification (UDI) system introduced in the MDR/IVDR?

• To improve device traceability, recall efficiency and post-market surveillance
• To increase product price transparency
• To provide manufacturers with a new marketing code
• To replace CE marking entirely

Correct Answer: To improve device traceability, recall efficiency and post-market surveillance

Q9. Under the MDR, when can a manufacturer rely on clinical data from an equivalent device rather than conducting a new clinical investigation?

• Only when strict equivalence criteria are satisfied regarding clinical condition, technical, biological and clinical characteristics and access to the equivalent device’s data
• Always, if the equivalent device is marketed anywhere in the world
• Never; clinical data must always come from a new clinical investigation
• Only for implantable devices

Correct Answer: Only when strict equivalence criteria are satisfied regarding clinical condition, technical, biological and clinical characteristics and access to the equivalent device’s data

Q10. What does “grandfathering” mean in the context of the transition from MDD/AIMDD/IVDD to MDR/IVDR?

• Devices certified under the old Directives could remain on the market until the expiry of their valid certificates subject to transitional provisions
• All old certificates were immediately invalid on the MDR/IVDR application date
• Manufacturers were exempted from MDR requirements permanently
• Only new devices were allowed to use old clinical data

Correct Answer: Devices certified under the old Directives could remain on the market until the expiry of their valid certificates subject to transitional provisions

Q11. What is Post-Market Clinical Follow-up (PMCF) under MDR?

• A proactive part of post-market surveillance required to collect clinical data after the device is placed on the market
• A marketing survey to ask users about device price
• An optional activity only for Class I devices
• A manufacturing quality control test performed before market release

Correct Answer: A proactive part of post-market surveillance required to collect clinical data after the device is placed on the market

Q12. Which of the following best describes a Notified Body’s role under the MDR?

• Assess conformity of higher-risk devices, audit manufacturer quality systems and issue certificates where conformity is demonstrated
• Write clinical evaluation reports for manufacturers
• Grant marketing authorizations on behalf of the European Commission
• Set device prices in the EU market

Correct Answer: Assess conformity of higher-risk devices, audit manufacturer quality systems and issue certificates where conformity is demonstrated

Q13. How does IVDR classify in vitro diagnostic devices by risk?

• Classes A, B, C and D with D being highest risk
• Classes I, IIa, IIb and III like MDR
• Low, Medium and High only
• Single class for all IVDs

Correct Answer: Classes A, B, C and D with D being highest risk

Q14. Which EU system is used to share vigilance reports and safety information across member states?

• Eudamed vigilance module
• European Medicines Agency (EMA) clinical database
• World Health Organization (WHO) device registry
• Notified Bodies forum password-protected site only

Correct Answer: Eudamed vigilance module

Q15. Is clinical evaluation a continuous process under the MDR, requiring updates throughout the device lifecycle?

• True — clinical evaluation must be planned, performed and regularly updated over the device lifecycle
• False — only required before initial CE marking
• False — only required by Notified Bodies
• True — but only for in vitro diagnostics

Correct Answer: True — clinical evaluation must be planned, performed and regularly updated over the device lifecycle

Q16. Which international standard is the reference for medical device risk management and is widely used to meet MDR requirements?

• ISO 14971 (Application of risk management to medical devices)
• ISO 9001 (Quality management systems)
• ISO 13485 (Quality management for medical devices only)
• ISO 14001 (Environmental management)

Correct Answer: ISO 14971 (Application of risk management to medical devices)

Q17. Under MDR classification rules, which of the following device types is most likely to be classified as Class III?

• Long-term implantable active therapeutic devices delivering energy to vital organs
• Simple wound dressings
• Non-sterile tongue depressors
• Over-the-counter spectacles without corrective power

Correct Answer: Long-term implantable active therapeutic devices delivering energy to vital organs

Q18. Which device classes under the MDR require periodic safety update reports (PSUR) as part of post-market surveillance?

• Class IIa, IIb and III devices (with specific frequency requirements depending on class)
• Only Class I devices
• All devices including Class I regardless of risk
• Class A devices under IVDR only

Correct Answer: Class IIa, IIb and III devices (with specific frequency requirements depending on class)

Q19. Which conformity assessment route allows a manufacturer to self-declare conformity and affix CE marking without Notified Body involvement?

• Class I non-sterile, non‑measuring devices (self-declaration)
• Class III implantable devices
• Class IIb sterile devices
• All in vitro diagnostics under IVDR

Correct Answer: Class I non-sterile, non‑measuring devices (self-declaration)

Q20. Who is principally responsible for drawing up and signing the EU Declaration of Conformity for a medical device?

• The manufacturer (or the authorised representative acting on the manufacturer’s behalf)
• The Notified Body that issued the certificate
• The national competent authority
• The device distributor

Correct Answer: The manufacturer (or the authorised representative acting on the manufacturer’s behalf)

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