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Clinical Evaluation Report (CER)

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

The MDR 2017/745 and revised CER guidance (MEDDEV 2.7/1 rev 4) both reflect more stringent requirements for clinical data and post-market requirements, highlighting the importance of ensuring your documentation is all in order. You will also need to update your CER on an annual basis. So get in touch with our team if you would like any additional support on this

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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FAQs on Clinical and Post-Market

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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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