Ever wondered if the product that you are using is safe? Ever wondered how is the safety assured? Ever wondered where do all the complaints and feedback go? A simple answer to all these is a Clinical Evaluation Report.

A Clinical Evaluation Report (CER) documents the clinical data of a medical device and helps in assessing the safety and efficacy of the medical device’s performance. A CER is vital to support design validation and includes the clinical data, analysis, and appraisal of the data, and conclusions on the safety and efficacy of the device.

“A goal without a plan is only a wish”  

A comprehensive CER is a key component to the CE Marking. 

As everyone consistently acknowledges the interconnection between design and clinical success, Regulators around the world are ramping up expectations for clinical evaluation of medical devices. And this is very evident from the increasing emphasis on clinical data and its appraisal in regulations and MEDDEV 2.7/1.

According to the MEDDEV 2.7/1 Revision 4 (June 2016), a CER should summarize the intended use, residual risks, and benefits and should be a stand alone document. The CER should be prepared to take into account the state of the art, substantial equivalence to preexisting devices in the market, and should be evidence in line with the claims made for the device. The CER is a live document and should be updated with the risks associated with the use of the device as Manufacturers become aware of them at the post-market stage.

(Reference: MEDDEV 2.7/1 Rev.4 Clinical Evaluation: Guide for Manufacturers and Notified Bodies)

If approached systematically, a CER can take less time to generate and can form a strong basis of device’s safety and efficeny.

Focus of CER

A CER can be written focusing on one of the following:

(I). Literature Route

Leveraging existing published data to support device functions and equivalence with similar device from a technical, biological and performance standpoint.

(II). Clinical Investigation Route

Conducting clinical trials to assess the safety and/or performance of a medical device and summarizing it.

(III). Combination (I+II)

Utilizing both route I and II above, and the CER documents both literature as well as clinical investigation studies.

When creating a CER, one should take into account:

State of Art

State of the Art section should include current knowledge of the medical field, applicable standards and guidance. It should also include a brief summary of the benchmark devices, available medical alternatives, clinical background and hazards.

Equivalence

The device under evaluation and the comparable device would be demonstrated as equivalent based on the clinical, biological and the technical characteristics. There should be no difference in the clinical safety and performance of the device for which equivalence is demonstrated.

Risk  Benefit Analysis

The CER should discuss all the risks associated with the device and analyse the data to determine the safety and performance of the device. The CER should outline the benefits and the risks associated with the device’s usage. This aids in understanding plausible risk associated with the device usage.

Evaluator’s Qualification

The clinical evaluation should be evaluated by a qualified individual who has an expertise at the device technology and its application and possesses a higher education degree coupled with minimum 5-10 years of documented professional experience. Any deviation from this must be duly justified and documented in the Clinical Evaluation Report.

Frequency of the CER Updates

Clinical evaluation report is a live document that should be updates throughout the product life cycle. The CER needs to be updated at least annually for devices with high risk and every 2-5 years for device that fall under low risk.

As per the new EU regulatory requirements the safety and efficacy of the device should be based on some clinical data (literature or study) as it helps in identifying and scrutinizing the risks involved in the usage of the device, and in turn streamlines the process for CE marking. To timely receive your CE, check where your CER stands.  

About Us

Elexes helps medical device manufacturers, aspiring for CE marking, by creating an organised Technical File of which a comprehensive Clinical Evaluation Report (CER) is a critical part. For any questions/comments please write to jennifer@elexes.com

References

• MEDDEV 2.7/1 rev. 4 Clinical Evaluation: Guide for Manufacturers and Notified Bodies
• PC: Freepik