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Performance Evaluation Report (PER)

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

Your PER is the key document for performance evaluation, bringing all elements of clinical evidence together for the device in context with benefit-risk statements and state-of-the-art status.

It provides you with an opportunity to discuss your IVD device in terms of its intended purpose and risk classification. Therefore, manufacturers should compile evidence, determine the benefit-risk and document the performance evaluation and its output as part of this report.

However, many IVD manufacturers face challenges in producing the clinical data necessary under the IVDR due to significantly more stringent requirements.

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FAQs on Clinical and Post-Market

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At Apotech, we can offer end-to-end support in the following areas:

Clinical evidence justification
Literature search methodology, protocol and report
Device description, intended use, performance and safety claims
Scientific validity, analytical performance and clinical performance
Clinical evidence and state-of-the-art comparison
PMPF evaluation report updates

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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