The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to consider defining a robust CER strategy.
Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device.
Following are some steps to follow -
1. Define a CER protocol and strategy
2. Demonstrate equivalence
3. Evaluate literature review data
4. Determine requirement for clinical investigation
5. Monitor post-market activities
In line with the expectations of the European Authorities, clarity and structure are at the core of everything we do at IZiel. Ensuring thoroughness and scientific accuracy at every step of collating data and presenting it in the CER are our prime objectives, and receiving approval is the clear endpoint for every report we create. EU MDR identifies the use of clinical investigations as a method of assessing the benefit-risk ratio of medical devices. Additionally, risk assessment is useful to justify any foreseeable risks to trial subjects when weighed against the benefits. These should be well-documented in the clinical investigation plan. The plan is also required to include an ongoing monitoring strategy for the risks and the benefit-risk ratio.
Working in-tandem with our clients, we endeavour to provide every detail asked for and more, keeping a keen eye on objectivity, completeness and evidence-backed content, throughout the process.
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