Clinical Evaluation (CER) under MDR

Clinical evaluation is mandatory under MDR (EU) 2017/745 for all medical devices and must be maintained throughout the device lifecycle. We help manufacturers build a defensible clinical evidence strategy and deliver a Clinical Evaluation Report (CER) aligned with MDR expectations.

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What Clinical Evaluation Is

Clinical evaluation is a systematic and planned process to continuously generate, collect, appraise, analyse and assess clinical data related to a device in order to verify clinical safety and performance and to support the benefit‑risk profile.

It is closely linked to the device’s intended purpose, claims, risk management, PMS and (where applicable) PMCF.

Typical Clinical Data Sources

• Clinical investigations (own device)
• Published scientific literature
• Post‑market data (complaints, vigilance, PMS outputs)
• Equivalence data (where justified and supported)

Clinical Evaluation Process (Practical Steps)

1. Define scope — device, variants, intended purpose, claims and target population.
2. Clinical evaluation plan (CEP) — strategy, acceptance criteria, and evidence plan.
3. Literature search — protocol, databases, keywords, inclusion/exclusion, screening.
4. Appraisal — quality and relevance assessment of the selected data.
5. Analysis & conclusions — clinical safety/performance and benefit‑risk conclusions.
6. CER maintenance — updates aligned with PMS/PMCF and significant changes.

Common Challenges (Where We Add the Most Value)

• Borderline products and correct intended purpose/claims framing
• Weak literature evidence or insufficient state‑of‑the‑art alignment
• Equivalence: demonstrating technical/biological/clinical equivalence
• Consistency between CER, risk management and PMS/PMCF outputs
• Notified Body questions and expectations for higher‑risk devices

What We Deliver

• Clinical Evaluation Plan (CEP)
• Literature search protocol + screening log (as needed)
• Literature appraisal and data extraction (as applicable)
• Clinical Evaluation Report (CER)
• Equivalence assessment support (where applicable)
• PMCF recommendations and alignment with PMS documentation

Working on MDR certification? See MDR certification. Need classification first? See Device classification.

What We Need From You

• Device description, intended purpose, variants/SKUs
• Labeling/IFU and marketing claims
• Risk management file summary (or key hazards/benefits)
• Existing clinical data, complaints and PMS outputs (if any)
• Comparable products and state‑of‑the‑art references (if available)

FAQ

Is a CER required for Class I devices?

Yes. MDR requires clinical evaluation for all devices; the depth and evidence expectations depend on risk class and claims.

Can we rely on equivalence instead of our own clinical investigation?

Sometimes, but equivalence is challenging under MDR and requires strong technical/biological/clinical justification and access to data.

How often must we update the CER?

It depends on device risk, PMS findings and changes. We help set an appropriate update strategy and triggers.

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