Q&A with Mieke Roelants, Director Regulatory Affairs & Market Access, genae Belgium
Q: By when do I need to update the Clinical Evaluation Report (CER)?
A: The Clinical Evaluation Report is just the last phase of the clinical evaluation process itself. It’s important to realize that the entire process including the report writing should be repeated on a regular basis.
Information on the frequency is one of the items which has been further clarified in the MEDDEV 2.7/1, the guidance document which was published in June 2016. Updating of the clinical evaluation is needed whenever you receive new information from your PMS that affects the clinical evaluation.
If this is not the case, then frequency depends on the risk of the device, but also on how well established the technology is. In short, you can say that the frequency varies from annually to every 2 to 5 years.
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• How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
• Why is it important for manufacturers to focus on the health economics of their device?
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