Module 15 2022

5/19/2022

MDR Clinical Evaluation

MDCG 2020-13 (CEAR Template)

MDCG 2020-6 (legacy devices)

MDCG 2020-5 (equivalence)

MDCG 2020-1 (software)

MEDDEV 2.7.1 Rev 4

MDR (Annex XIV)

MDR (Article 61)

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Types of CER

Early stage CER

- Do I have equivalent devices with relevant data to leverage? - What is the current State Of The Art? - What are the clinical risks to mitigate? - What should be my claims? - What kind of pre-clinical data, hence clinical data will I need to produce?

Submission CER - Do I have all the data needed to support compliance with GSPR ? - Are there any new published data confirming/revising my initial CER? - Have I generated all necessary data to support the device’s claims and addressed risks? - Is my Risk Management file aligned with the clinical evidence? - Is my labelling and IFU aligned with data?

Maintenance CER

- Is my device still « SOTA »? - Are there any changes made to my device that would contradict initial conclusions? - How has PMS/PMCF impacted my clinical data? - What has changed in the therapeutic area, what are my competitors doing? - Is my device « still » safe and effective? - Is my Benefit/Risk ratio still favorable?

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