Any device intended to be marketed in the European Union must bear a CE mark. The process and data requirements for obtaining CE certification of Medical Devices varies with the class of a device. Low risk class I devices can carry out CE-Self Certification, whereas other classes of devices (IIa, IIb, III) must process the CE mark certification through an accredited Notified Body. The manufacturer must submit CE technical file to NB for evaluation and issuance of CE mark approval and issuance of CE certificate. The Clinical Evaluation Report (CER) is one of the documents that shall be submitted along with the CE Technical File for complying with CE marking requirements.
What is a Clinical Evaluation Report (CER)?
Clinical evaluation report writing includes, the assessment and analysis of clinical data pertaining to a Medical Device, to verify its clinical safety and performance. The clinical evaluation of medical devices is based on comprehensive analysis of pre- and post-market clinical data relevant to the intended use. The Clinical Evaluation Report includes data specific to the device, as well as any data relating to devices claimed as equivalent by the manufacturer.
A Clinical Evaluation Report (CER) consists of scientific literature and 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 Clinical Evaluation Report of a medical device demonstrates that the device achieves its intended purpose without exposing users and patients to further risk.
The Clinical Evaluation Report must be updated every year. In case the device is marketed for significant period and is well established to be safe with no significant risk, the Clinical Evaluation Report can be updated in every 2-5 years. Any design changes made to the device design, any new information from PMS data could trigger an update of the CER Report.
The clinical evaluation of medical devices as framed in the Clinical Evaluation Report(CER) is based on the factors listed below.
- Scientific literature currently available; and/or
- Clinical investigations made; or
- Whether demonstration of conformity with essential requirements based on clinical data is not deemed appropriate
Stages of Clinical Evaluation Report (CER) Writing
Referring to the new MDR - MEDDEV 2.7/1 Revision 4, there are 4 different stages to perform a clinical evaluation of Medical Devices, to prepare a comprehensive EU MDR Clinical Evaluation Report.
New EU MDR and Clinical Evaluation Report
With the new extended timelines for the EU Medical Device Regulations (MDR) till May 2021, manufacturers of already CE marked devices, in compliance with earlier EU MDD, have time to update their Clinical Evaluation Reports and ensure that they include additional data required by the MDR.
The Medical Device manufacturers entering the EU market for the first time, must ensure that their Clinical Evaluation Report is compliant with the EU MDR regulations.
Freyr caters end-to-end CE Certification Services to device manufacturers including, Clinical Evaluation Report writing in line with MEDDEV 2.7/1 Revision 4 guidelines. With strong EU Medical Devices regional expertise, Freyr caters to agency-wise requisites and customizes the Clinical Evaluation Report accordingly.
- End-to-end Clinical Evaluation Report writing support including, literature search, as per MEDDEV 2.7/1 revision 4 and the EU Medical Device Regulation (MDR) guidelines
- Identify, search, analyze and put together the appropriate scientific literature applicable
- Developing Clinical Evaluation Report template for your organization
- Gap Analysis for existing Clinical Evaluation Report
- DMS tool for your team to collectively contribute to Clinical Evaluation Report writing
- Integrating PMS Data
- Develop standard operating procedure for your team, to compile PMS data to update Clinical Evaluation Reports
- Handling periodic updates of existing Clinical Evaluation Report, as per the EU MDR guidelines
- PMS data support for existing devices in the market
- CE Marking Compliance and CE Marking Services
- Assured compliance to recent applicable regulations
- Team of qualified clinical experts
- Cross functional inputs from Medical Device experts to comply with requirements
- Full-scope service from compliance, review, and planning