Post-Market Clinical Follow-Up (PMCF)

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 mandates that manufacturers gather clinical data after market launch through a Post Market Clinical Follow-Up (PMCF) process. This complements pre-market clinical evaluation and ensures safety and performance in real-world conditions.

Apotech can support with:

PMCF plan development
Literature review and data interpretation
Protocol and statistical analysis plan development
PMCF study report preparation

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FAQs on Clinical and Post-Market

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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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