Factors to keep in mind preparing for Clinical Evaluation.
Clinical data allows manufacturers to make decisions and conclusions on the safety and performance of their devices. It enables manufacturers to quantify the risk/benefit ratio of the medical device. The EU MDR has greatly impacted the way medical devices are regulated and as part of this, manufacturers need to create and maintain clinical evaluations.
The Clinical Evaluation Report (CER) is an essential component of the conformity assessment of a medical device. Their purpose is to provide a comprehensive summary of the device’s design and composition, its intended applications and any applicable literature reviews. CERs can be extensive, depending on the scope of the evaluation needed. Overtime manufacturers will be able to identify the most appropriate approach and templates that reflect their needs.
What needs to be considered when preparing for and performing clinical evaluations efficiently? In summary, manufacturers should:
- Identify scope of the medical device, CER report and create a clinical evaluation plan (CEP).
- Identify relevant pre- and post-market clinical data from existing literature, clinical experience, clinical trials, or combination.
- Evaluate literature review data. Assess the validity of the data, relevance to clinical evaluation, significance, quality, and importance.
- Analyse the clinical data. Conclude the device’s compliance with essential requirements for safety and performance, which should include benefit/risk profile, residual risk and uncertainties or unanswered questions.
- Based on the data, summarise and articulate conclusions in the CER. It should contain strong clinical evidence for conformity assessment to allow approval of the device for sale in the European markets, and similar reports in other global markets.
- Regular updates are required as part of post-market surveillance and vigilance activities. Monitor activities and any noteworthy changes that effect the initial data must be stated and CER must be appended accordingly. Failure to do so could be a risk to conformity.
To lessen the burden on manufacturers and their representatives when completing clinical evaluations for their medical devices, keep the following factors in mind:
- Indications for use. Confirming your indications eases the route to conformity and save less work in the future.
- Guidelines. Refer to the most recent MDGC documents for guidance, suggested formats and checklists.
- Timing is key. Make sure adequate time is allocated for completion. Unexpected delays are inevitable.
- Teamwork is key. Utilise the expertise of multidisciplinary teams within your company who know the device.
- Plan the approach and remain objective. Ensure the results reach their own conclusion. It is important to include all findings and avoid bias.
- Updates to CER. New clinical data and findings from Post Market Clinical Follow-Up (PCMF) and/or publications are required to be included into the CER. Failure to do so can risk conformity.
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- Main Blog
- What is a Clinical Evaluation?
- Steps by Step guide for Clinical Evaluation reporting – Medical Devices in the European Union
- Clinical Evaluations and Challenges