Technical Documentation FAQ
Are there any guidelines for the structure of the Technical Documentation?
What should be in each section? What do Notified Bodies expect to see?
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FAQ
Summary of Safety and Clinical Performance FAQ
What is the Summary of Safety and Clinical Performance (SSCP)?
Does it apply to your device? Where can you find guidance?
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State Of The Art FAQ
What does “state of the art” mean in the context of medical devices?
Why is it important? What do you need to do?
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Risk Management FAQ
Why do manufacturers need Risk Management?
How is it defined for medical devices? What ISO is applicable?
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Post Market Surveillance FAQ
What is Post Market Surveillance (PMS)?
What’s it used for? Why do you need it?
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Post Market Clinical Follow up FAQ
What is Post Market Clinical Follow-up (PMCF)?
What is the point? What do you need to be compliant?
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Conformity Assessment Procedures under MDR FAQ
What is the process for demonstrating conformity of devices?
How does this differ depending on device class?
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Clinical Investigation FAQ
What are clinical investigations according to the EU MDR?
Why is clinical data required? What types of clinical investigation can be conducted?
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Clinical Evaluation FAQ
What is Clinical Evaluation?
What guidance is there? What documents do you need?
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Clinical Evaluation Assessment Report FAQ
What is a Clinical Evaluation Assessment Report (CEAR)?
What is its purpose? Why do medical devices need one?
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