EU MDR and FDA Regulatory Affairs Interview Questions and Case Studies

Regulatory affairs interviews mix knowledge questions with scenarios where you must choose a strategy and defend it. This guide extends our top 10 RA interview questions with 8 further EU MDR and FDA questions and three case studies with ideal answers.

How regulatory interviewers think

They look for four things: you can classify and choose a pathway, you can explain the evidence required, you communicate risks clearly to non-regulatory colleagues, and you know when to escalate. Use background from our EU MDR and IVDR overview and US FDA regulations guide.

Eight questions with model answers

1. How are devices classified in the EU?

Model answer: “Under MDR Annex VIII, 22 rules place devices in Class I, IIa, IIb or III based on intended purpose, contact duration, invasiveness, whether active and body system. Software is often classified under Rule 11. Class decides the conformity assessment route.”

2. How are devices classified in the US?

Model answer: “FDA uses Class I, II and III by risk and controls. Class I is mostly exempt, Class II usually needs a 510(k), Class III usually needs a PMA. I check the product code and classification regulation for similar devices.”

3. When would you use De Novo instead of 510(k)?

Model answer: “When the device is novel low-to-moderate risk and there is no suitable predicate. A Pre-Submission meeting would help confirm that before investing in testing.”

4. What is in the EU technical documentation?

Model answer: “Annex II and III content: device description and specification, labeling, design and manufacturing information, GSPR checklist, benefit-risk and risk management, product verification and validation, clinical evaluation, and the post-market surveillance documentation.” See EU MDR technical documentation.

5. What is a predicate and how do you choose one?

Model answer: “A legally marketed device you compare against to show substantial equivalence: same intended use, and either the same technological characteristics or differences that do not raise new questions of safety and effectiveness, supported by data. I screen candidates by intended use, technology and clearance history.” Read selecting a predicate device.

6. What changed with the QMSR?

Model answer: “FDA’s quality regulation now incorporates ISO 13485:2016 by reference, effective 2 February 2026, so FDA and international expectations align more closely.”

7. What is EUDAMED?

Model answer: “The EU database for devices. The first four modules, covering actors, UDI and device registration, notified bodies and certificates, and market surveillance, became mandatory from 28 May 2026. I would confirm the current status of other modules on the Commission website.”

8. How do you handle a regulator question you cannot answer?

Model answer: “I acknowledge it, clarify what is being asked, consult the technical owner, check guidance and respond within the deadline with evidence. If more time is needed I request it formally.”

Case study 1: choosing a pathway for a new wound-monitoring app

Scenario: A start-up has a smartphone app that analyses wound photos and suggests a healing score used by clinicians. They want to sell in the US and EU.

Ideal answer: “First, qualify it: the intended use drives diagnosis or monitoring decisions, so it is likely a medical device software. In the EU I would check Rule 11 for class, which may place it in Class IIa or higher, then plan a notified body route, GSPR, software lifecycle under IEC 62304, usability, cybersecurity and clinical evaluation. In the US I would search for predicates and product codes for similar software, consider a 510(k) or De Novo, and plan a Pre-Submission. I would align one set of evidence for both markets and flag the cost and time differences to management.” See Is my software a medical device?

Case study 2: FDA asks for additional information

Scenario: FDA issues an additional information request on day 60 with six deficiencies, two involving a performance test.

Ideal answer: “I would log the response deadline, hold a meeting with owners to read each deficiency precisely, and decide which are answerable with existing data and which need new testing. If new testing needs more than the response window allows, I would discuss options with FDA, including requesting an extension within what is allowed. I would write each response with the question first, then data, then conclusion, and have it reviewed by someone not involved. I would keep the tone factual.” See 510(k) deficiency letters.

Case study 3: legacy device and MDR transition

Scenario: A company sells a Class IIa device under a directive certificate that expires soon. Management asks whether they can keep selling.

Ideal answer: “I would check the transitional provisions in Regulation (EU) 2023/607: continued placing on the market is possible until the end of the extended period (31 December 2028 for Class IIa) only if conditions are met, including a valid certificate or extension status, no significant changes, a compliant QMS and a written agreement with a notified body in time. I would confirm each condition with evidence, check notified body status and the current legislation, and prepare the MDR technical documentation in parallel. I would present the risk and timeline to management.” See EU MDR compliance challenges.

Mistakes to avoid

• Giving a date or fee from memory without saying it should be verified.
• Ignoring the business context. State the trade-offs.
• Describing a strategy for one market only when the question is global.

Frequently asked questions

Should I mention RAC or other certifications?

Mention credentials briefly if relevant, but spend most of the time on practical examples of work you did.

How current must my knowledge be?

Very. Regulations and guidance change, so say where you would verify a date or requirement.

What if my experience is only in one region?

Be honest, then show you understand the structure of the other system and are learning it.

Dates and requirements change. Verify against official sources before relying on any of the details above.

Talk to the AptSkill team

Want a mock regulatory interview or a course recommendation? Send us a message.