The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in May 2017 has new, stricter criteria for CER (Clinical Evaluation) reports, such as the basis of establishing an equivalence with another device and the quality of data considered in your clinical evaluation.
We consider the 5 issues that you should consider when creating a Clinical Evaluation Report.
1. Define a CER protocol and strategy
Identify the scope of the medical device and the Clinical Evaluation Report and create a plan for the clinical evaluation (performance, safety, and risk/benefit endpoints).
2. Demonstrate equivalence in Clinical Evaluation Reports
Among the most complex aspects is the term ‘equivalence’, which – if demonstrated – would exempt manufacturers of high-risk devices from performing costly and lengthy clinical investigations. This section must address whether the clinical evaluation is based on scientific literature and justify equivalence if clinical data is not appropriate for the device. It is critical to avoid the common mistake of selecting equivalent devices that are not relevant to your product. Documented data must be identified and analyzed for each equivalent device and for the differences between devices.
3. Evaluate literature review data
It is critical that literature surveys are conducted in a systematic process. The clinical context should be heavily detailed and address: 1) Sources, 2) Search methods (including selection criteria for the literature review), 3) Quality control measures, 4) Results, 5) Number and type of research literature. The data analysis should include an objective method (multiple reviewers)
4. Determine the requirement for clinical investigation
The requirement for a clinical investigation is determined by the risk profile of the device. High-risk devices and devices based on innovative technologies (or for a new intended use) must be subject to a clinical investigation.
5. Monitor post-marketing activities
Under the MDR, PMS activities must be adequately planned and documented in the CER. The processes for evaluating ongoing clinical data and updating CERs must also be documented.
Talk To Us About Clinical Evaluation Reports
Acorn Regulatory is unique in that we employ a full-time staff of experts across many disciplines including clinical and device. We have extensive experience in writing clinical evaluation reports for client companies. Talk to us today to see how we can help you with issues related to clinical evaluation reports.
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