Clinical evaluation is required for medical devices under medical device directive 93/42/EEC and medical device regulation 2017/745 or even 2017/746 to some extend (for in vitro diagnostic devices). There is also a lot of guidance for clinical evaluation in the context of CE marking: MEDDEV 2.7.1 is the most important one.
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. The evaluation is based on comprehensive analysis of pre- and post-market clinical data relevant to the intended use. This includes data specific to the device as well as any data relating to devices claimed as equivalent by the manufacturer. The whole process is documented in a clinical evaluation report (CER).
The following example of data can be prepared for this purpose:
- Clinical Investigations
- Literature search and review
- Equivalent product data (literature and adverse events) to demonstrate safety and performance)
- Clinical experience (implant registries etc…)
- Post-market data
We should distinguish the following aspects:
- State of the art: how to position the device or technologie in the light of the current knowledge and available products. This is usually done by performing a literature search for the indication of use with a recent time window
- Safety and performance claims: to demonstrate that the claims are well supported, it is important to identify all available literature for the product itself and equivalent product.
A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device. A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.
Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File. The Technical File is an essential step to obtaining CE Marking for your device, which is required to sell or distribute medical devices in Europe.
How to prepare a Clinical Evaluation Report for medical devices
A clinical evaluation takes place in three steps. In step one, manufacturers identify clinical data from existing literature, clinical experience, clinical trials, or any combination of the three. Stage two involves appraising the data’s relevance, applicability, quality, and significance. The third step requires you to articulate your conclusions in the CER, based on the data you collected.
Approach the CER as a standalone document even though you will include it with your technical file or design dossier. A list of possible elements to include in your CER is as follows:
- General information: device and manufacturer name
- Concise physical and technical device description and intended application
- Outline of intended therapeutic or diagnostic claims
- State of art discussion
- Clinical evaluation and data types
- Summary of clinical data and review
- Describe analyses used to assess performance, safety, and relevance/accuracy of product literature
- Conclusions about safety, performance, and conformity
This is also supported by a literature search protocol and report as well as post-market data
Required updates to your Clinical Evaluation Report
Regular updates to your CER are required as part of your post-market surveillance and vigilance activities. You must record any notable changes that impact the initial data and append the CER accordingly. Failure to do so could jeopardize your conformity with the Medical Devices Directive.
Europe’s new Medical Device Regulation (MDR) will impose even stricter requirements for Clinical Evaluation Reports, such as the basis of establishing equivalence with another device and the quality of data considered in your clinical evaluation.
Our Services include the following:
- Consultation : best strategy to develop for the clinical evaluation plan
- Review of the state of the art
- Post-market data preparation
- Preparation of literature search protocol
- Preparation of literature research report
- Performance and safety analysis and critical appraisal
- Link with risk assessment
- Clinical Evaluation Report preparation: overall summary of all the above
If you wish to prepare some or all of the above, get in touch with us on our contact page.
You may also review our page about CE marking and FDA compliance.
[i] Council Directive 67/548/EEC, Annex I, of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.