Performance Evaluation Plan (PEP) for IVD Devices

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 PEP provides you with the opportunity to combine the design inputs for performance and safety with your risk management outputs to align them with the IVDR requirements described in Annex I.

Our team at Apotech can collaborate with you to craft a structured PEP, aligning with factors like your IVD's risk class, its intended use and various technological specifications to ensure complete compliance with the more stringent IVDR.

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FAQs on Clinical and Post-Market

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We can also support you with:

Device classification
The intended purpose and characteristics of your device
Identification of analyte or marker
Intended use, user and indications for use
General Safety and Performance Requirements (GSPR)
Analytical methods and clinical performance
Development, validity, analytical and clinical performance
State-of-the-art status
Benefit-risk
PMPF plan

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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