Post Market Surveillance (PMS)

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

Under EU MDR, manufacturers must monitor and evaluate device safety and performance post-market through a structured Post Market Surveillance (PMS) system.

PMS includes planning, implementation, reporting, and regular updates for every medical device

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FAQs on Clinical and Post-Market

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Apotech can support with:

PMS plan and report development
Post Market Clinical Follow-Up (PMCF) plan and report
Vigilance systems
Periodic Safety Update Reports (PSURs)
Complaint and adverse event handling
Risk management integration
Field Safety Corrective Actions (FSCAs)

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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