IN ONE SIMPLE SENTENCE
Combining and evaluating clinical evidence to judge whether device safety, performance and clinical benefit are adequately supported.
What is this service?
Clinical evaluation brings together all relevant clinical evidence and asks whether the total evidence supports the device’s clinical safety and performance for its intended purpose.
GOAL
Build a structured, documented scientific argument about device safety, performance and clinical benefit.
What can MICT do here?
Review literature, appraise evidence quality, use device-specific study data, compare with current knowledge and prepare or update the CER.
TYPICAL INPUTS
What we usually need to start
- Scientific literature
- Device-specific clinical studies
- Technical and performance evidence
- Risk management
- PMS / PMCF when available
TYPICAL OUTPUTS
What this stage can deliver
- Clinical Evaluation Plan when needed
- Literature search and appraisal
- Clinical Evaluation Report (CER)
- Clinical evidence gap list
- Recommendations for additional data or PMCF
Important terms in plain language
Clinical Evaluation
The ongoing process of assessing clinical evidence for a medical device.
CER
Clinical Evaluation Report; the formal report summarizing the clinical evaluation.
Literature Review
Systematic searching and review of relevant scientific literature.
Appraisal
Assessment of the quality and reliability of a source or study.
Clinical Benefit
A measurable positive impact on patient health or clinical management.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
For a blood-pressure monitor, the CER can evaluate device accuracy data, device-specific clinical studies, relevant literature and post-market experience together.