Editor: What To Know
- The CER is often one of the most challenging aspects of the medical device regulatory process, requiring a high level of expertise and considerable investment of time and resources.
- A CER is submitted when a clinical study is conducted in support of an application for a marketing authorization.
- It assesses the clinical risks associated with the use of a device, its expected clinical performance in an intended population and any contraindications for use.
By Ramya Sriram
Open talent platform Kolabtree has announced the release of an expert-sourced Clinical Evaluation Report template to help medical device manufacturers meet EU MDR requirements. The template aims to make it easier for medtech businesses to understand what they need in order to achieve compliance required for their products to be placed in the European market.
What is a CER?
The clinical evaluation report (CER) provides clinical data to support the clinical safety and efficacy of a device. It assesses the clinical risks associated with the use of a device, its expected clinical performance in an intended population and any contraindications for use. The clinical evaluation requirements and processes are outlined in Article 61 and Annex XIV of the EU MDR. A CER is submitted when a clinical study is conducted in support of an application for a marketing authorization. The report provides reasonable assurance that the device complies with all applicable requirements; this includes both legal and technical requirements.
The CER forms part of the Technical File and allows devices access into Europe if compliant. Approved devices get the coveted CE Mark that certifies that the device is safe and meets required standards.
On-demand clinical evaluation specialists
The CER is often one of the most challenging aspects of the medical device regulatory process, requiring a high level of expertise and considerable investment of time and resources. However, as the expert economy grows, companies can now access highly-qualified specialists who can help them meet all the industry standards needed for approval.
The EU MDR regulation, which was previously supposed to be implemented in May 2020, was delayed by a year due to the pandemic and came into effect in May 2021. In that one year, a growing number of people left their jobs in search of better opportunities that offered flexibility. As research funding was cut, scientists around the world found themselves looking for alternative sources of income while also offering their expertise on an on-demand basis. Medical device businesses, who had worked traditionally until then, started hiring freelancers for one-off projects. Data from Kolabtree shows that from 2019-2021, there was an increase in the demand for clinical evaluation report writers in companies both big and small: and all of these jobs mentioned that the position was “work from home”.
Ashmita Das, CEO of Kolabtree, says, “Since the pandemic hit, medical device manufacturers have been adapting new and flexible ways of working. At Kolabtree, we are connecting medtech companies to a global pool of medical device experts, who can help with regulatory compliance, product development and medical writing. This helps businesses save costs and time, while accessing the expertise they need to push the boundaries of innovation.” The CER sample has been sourced from Kolabtree consultant Girish Hirpara, a CER expert and regulatory consultant with over 14 years of experience in the medical device industry.
Download the CER sample from the Kolabtree blog here.
Editors’ Note: Ramya Sriram is Senior Content Marketing Manager at Kolabtree, the world’s largest freelance platform for scientists and industry experts.
