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Clinical Evaluation Report (CER) Services

The EU MDR 2017/746 and UK medical device regulations require manufacturers to maintain an up-to-date Clinical Evaluation Report (CER) as part of their technical documentation to obtain CE or UKCA marks.

A CER systematically assesses clinical data to demonstrate safety and performance. It supports regulatory compliance and ensures the medical device conforms to essential requirements.

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Apotech can support with:

  • Clinical scope, context, and state-of-the-art assessment
  • Device description and development history
  • Risk management alignment
  • Clinical evaluation methodology
  • Literature search execution
  • Analysis of safety and performance data

FAQs on MedTech clinical and post-market services

At Apotech, we aim to make our MedTech clinical and post-market services as simple to understand as possible, which is why we’re always on hand to answer any questions you might have. 

Here are some of the questions we get asked most often.

How does the European medical devices regulation (MDR 2017/745) impact CER requirements?

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