Clinical Affairs and Clinical Evaluation Interview Questions for Medical Devices (With Answers)

Clinical affairs and clinical evaluation roles combine science, regulation and writing. Interviewers test whether you can build a defensible body of evidence, explain it clearly and respond calmly when a notified body disagrees. This guide offers 8 model questions with answers and three case studies with ideal answers on legacy device evidence, equivalence and new safety signals.

What to prepare

Be able to describe one clinical evaluation or literature review from start to finish, including what you found, what the gaps were and how you handled them. Revise the clinical evaluation guide, the basics of PMCF and the EU MDR structure.

Eight common questions with model answers

1. What is the difference between a clinical evaluation and a clinical investigation?

Model answer: “A clinical evaluation is the continuing, systematic process of assessing all clinical data about a device to confirm safety, performance and benefit-risk. A clinical investigation is one source of data: a study in human subjects designed and run to generate clinical data about a device. An evaluation may include investigations, literature, post-market data or all of these.”

2. What goes into a clinical evaluation plan?

Model answer: “The intended purpose and target population, the GSPRs that need clinical support, the intended clinical benefits with measurable parameters, methods to assess safety and residual risks, acceptability criteria based on the state of the art, the literature search approach, how equivalence will be handled if used, and the clinical development and PMCF plan.”

3. How do you run a systematic literature search?

Model answer: “I write a protocol first: research questions, databases, search strings, inclusion and exclusion criteria, date limits and appraisal method. I run and record the searches so they can be repeated, screen records with documented reasons for exclusion, extract data into a standard form and appraise each study for quality and relevance. The report should let a reviewer repeat the search and reach the same set of papers.”

4. How do you demonstrate equivalence under the MDR?

Model answer: “By showing technical, biological and clinical equivalence in detail, with evidence, so there is no clinically significant difference in safety and performance. For implantable and class III devices I also need access to the other manufacturer’s technical documentation through a contract. If I cannot meet those conditions, I do not rely on equivalence and use data on my own device.”

5. When is a clinical investigation needed?

Model answer: “For implantable and class III devices the MDR requires one unless a specific exemption applies, such as a justified modification of a device the same manufacturer already markets, or well-established technology under defined conditions. For other devices I do a gap analysis. If existing data cannot support the claims and the benefit-risk conclusion, an investigation is needed.”

6. What is PMCF and how does it connect to the CER?

Model answer: “PMCF is the proactive collection of clinical data on a CE-marked device in use, to confirm safety and performance, detect emerging risks and check that the benefit-risk remains acceptable. Its plan comes from gaps in the CER, and its evaluation report feeds the next CER update. The two form a loop.”

7. What is the state of the art and why does it matter?

Model answer: “It is what is currently accepted as good practice in diagnosis or treatment for the condition, including alternative devices and treatments. The benefit-risk of my device is judged against it. Without a state-of-the-art analysis, acceptability criteria are arbitrary.”

8. Tell me about a clinical evaluation you worked on.

Model answer (STAR): “A notified body questioned the literature search for our class IIb device (situation). I was asked to fix the evaluation before the next review (task). I rewrote the protocol with explicit criteria, re-ran the search with documented screening, added post-market data and registered the appraisal method (action). The next review closed the question with minor comments only (result).”

Case study 1: notified body says evidence is insufficient for a legacy device

Scenario: Your class IIb device has been on the market for ten years under the directives. The notified body says the clinical evidence is insufficient for MDR.

Ideal answer: “I would ask for the specific gaps in writing, then do a structured gap analysis against the MDR requirements and the MDCG guidance on legacy devices. I would look at what we hold: ten years of post-market data, complaints, vigilance, registry data and literature. I would assess whether a more rigorous literature review and a PMCF study can close the gaps. If outcomes or safety in a subgroup are unproven, I would propose a PMCF with concrete objectives and timelines. I would present this to the notified body as a plan, with evidence of the strength of existing data, not as an argument that the device is old and therefore safe.”

Case study 2: equivalence for a class III implant

Scenario: Your team wants to claim equivalence to a competitor’s class III implant to avoid a clinical investigation. There is no contract with the competitor.

Ideal answer: “I would explain that without access to the other manufacturer’s technical documentation, equivalence is very unlikely to be accepted for an implantable class III device. I would check whether any exemption applies, for example if the device is a modification of one we already market. Otherwise, I would recommend planning a clinical investigation, or building the case on our own device’s data and well-established literature if the conditions allow. I would present the options and timelines to management, so the decision is made with the risk in view.”

Case study 3: PMCF reveals a new safety signal

Scenario: A PMCF study shows a higher rate of a known complication than the CER stated.

Ideal answer: “I would verify the data quality, then compare the rate with the state of the art and the risk file. I would inform the risk management and vigilance teams immediately, since this may affect residual risk, the labelling or reportability. I would update the CER with the new data, re-assess the benefit-risk conclusion and decide whether actions such as labelling changes, a field safety notice, or a design change are needed. I would also update the PMCF plan and keep a record of decisions, including communication with the notified body where required.”

Mistakes to avoid

• Describing a CER as a literature summary. It is a benefit-risk conclusion supported by evidence.
• Using equivalence as a shortcut.
• Forgetting that evaluation continues after CE marking.
• Ignoring the link to post-market surveillance and risk management.

Frequently asked questions

Do I need a clinical background?

It helps, but many successful evaluators come from engineering, life science or regulatory backgrounds. What matters is research methodology and clear writing.

Will I be asked to write during the interview?

Sometimes. You may get a short abstract or a paper to appraise. Practise summarising evidence and stating limitations clearly.

What other guides should I read?

See the EU MDR and FDA interview case studies and PMS and vigilance interview guide.

Model answers are examples; adapt them to your real experience.

Talk to the AptSkill team

Preparing for a clinical affairs interview? Send us a message.