To market a medical device in the European market with a successful CE certification, manufacturers are obliged to submit a Clinical Evaluation Report (CER) to the concerned notified bodies. 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. The CER includes data specific to the device as well as any data relating to devices claimed as equivalent by the manufacturer.
With new EU Medical Device Regulations (MDR) inching closer, manufacturers of already marketed devices whose CE technical files were already submitted, now have to review all their CERs and ensure that they include additional data from clinical studies.
The clinical evaluation 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
Referring to the new MDR - MEDDEV 2.7/1 Revision 4, there are 4 different stages to perform a clinical evaluation.
A 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 CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.
Emphasizing on the clinical evaluation requirements, Freyr caters end-to-end support to device manufacturers for preparing a CER 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 CER accordingly.
- End-to-end Clinical Evaluation Report (CER) writing support including literature search as per MEDDEV 2.7/1 revision 4 and MDD/AIMDD/EU Medical Device Regulation (MDR) guidelines
- Identify, search, analyze and put together the appropriate scientific literature applicable
- Developing CER template for your organization
- Gap analysis for existing CER
- DMS tool for your team to collectively contribute to CER writing integrating PMS data
- Develop standard operating procedure for your team to compile PMS data to update CERs
- Handling periodic update of existing CER as per MDD/AIMDD/EU MDR guidelines
- PMS data support for existing devices in the market
- 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