Background

A company making Cochlear Implant was in need of creating a new Clinical Evaluation Report (CER) for all the models of products they were manufacturing under the Cochlear Implant product series. As per the requirements, the CER was to be in compliance with MEDDEV 2.7.1 Rev 4. 

Challenges 

1. Determination of equivalence 

The Client was unable to identify the right equivalent device in order to establish equivalence per the technical, clinical and biological aspects. Equivalence being one important element of a CER, this was a complicated challenge that the Client needed support with. 

2. State of the Art 

The Client was aware of the start of the art in the medical field (related to Cochlear implant), but was unable to define and draft the section of the CER as per the MEDDEV 2.7.1 Rev 4 requirements.

3. Clinical literature search and report 

The Client did not have a literature search plan that could be applied in the identification of relevant scientific literature w.r.t the device under consideration. 

Solutions

1. Determination of equivalence – comprehensive research 

Elexes defined a methodology to evaluate multiple existing devices to demonstrate equivalence by assessing available clinical data, package inserts, device claims, clinical, technical and biological characteristics relating to the safety, performance, design characteristics and intended purpose of the device.

2. State of the Art – presenting the applicable details

Elexes drafted a strategy to identify all the relevant information relating to the medical condition, benchmark devices, gold standard device, and medical alternatives available to the target population. Elexes also leveraged relevant information from the implants registry and summarized and presented the applicable information. 

3. Clinical literature search and report – utilizing the right sources 

Elexes defined the literature review protocol and ensured that the literature identified was unbiased, i.e. it included all relevant data, both favorable and unfavorable, as applicable. All relevant databases were utilized for an extensive literature search and summarization based upon predefined appraisal criteria. The qualification of personnel to sign off on the report was laid out and accordingly the report was reviewed to assess the degree to which the selected papers reflected the intended application/use of the device. 

Results

With Elexes’ right advice at the right time the CER was compiled in line with the requirements of MEDDEV 2.7 Rev 4 in the most efficient manner, and there were minimal questions on the CER in the Notified Body (NB) audit. 

Key Takeaway

Creating CER helps in proving the safety and reliability of the device or IVD, but it is important to identify necessary and relevant scientific literature to prove this. When the initial strategy you make is robust, whether the CER is a complicated or an easy one, the document will come across well and go a long way in demonstrating that your product is safe and effective.