3. Scope of the clinical evaluation
Source: CER Template.pdf pages 9-10 (document: Mantra Systems Free CER Template, Edition 2)
3.1 Objective
State an objective for the Clinical Evaluation, e.g.:
- Establish conformity of the device with relevant General Safety and Performance Requirements
- Establish suitability for intended purpose
- Establish acceptability of benefit-risk profile
3.2 Hypothesis
The purpose of the hypothesis is to provide a scientific structure to the CER. Stating a hypothesis at the start of the CER enables it to be tested through appraisal and analysis of clinical evidence that follows.
It is sensible to structure the hypothesis around non-inferiority to comparable alternatives.
3.3 Device overview
3.3.1 General description of the device
Provide a full description of the medical device.
3.3.2 Device components
Describe the composition of the device. What materials is the device made from? Does the device incorporate any medicinal substances, tissues or blood products?
3.3.3 Principles of use
How is the device used in practice?
3.4 Device classification
Why is the subject device a medical device according to the definition in Article 2 MDR?
What regulatory class is the device? Provide justification by directly quoting the (relevant) rules in Annex VIII MDR. Get further guidance on working with MDR Annex VIII.
3.5 Manufacturer and sales history
State the name of the manufacturer, their address, and explain their experience in this field. State whether the manufacturer has any relevant credentials (e.g. ISO 13485-based quality system).
When was the device first CE-marked? In which countries/territories is the device sold? How many units have been sold to date?
3.6 Intended purpose & claims
What is the intended purpose of the device? What claims does the manufacturer make?
3.7 Indications, contraindications and precautions
What are the medical indications and contraindications for use of the device? What precautions and warnings are provided?
3.8 Target population and medical conditions
What is the target disease or condition?
3.9 Accessories or compatible devices
Describe any accessories associated with the device, and any compatible devices that it is designed to interface with.
3.10 Similar devices
Give an overview of any similar devices that have been identified (whether in EU or in other territories).