Get the free Annex I: Clinical evidence regarding sensitisation to - ec europa
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Annex I: Clinical evidence regarding sensitization to
individual fragrance chemicals and to natural extractsContents
Single chemicals .............................................................................
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What is annex i clinical evidence?
Annex I clinical evidence refers to the supporting documentation and data required to demonstrate the safety and efficacy of a medical device according to the regulations set by regulatory authorities.
Who is required to file annex i clinical evidence?
Manufacturers of medical devices are required to file annex I clinical evidence as part of the regulatory process for obtaining market approval.
How to fill out annex i clinical evidence?
Annex I clinical evidence is filled out by providing comprehensive data on the clinical performance, safety, and effectiveness of the medical device. This includes information on clinical trials, adverse events, and any relevant analytical or non-clinical studies.
What is the purpose of annex i clinical evidence?
The purpose of annex I clinical evidence is to provide regulatory authorities with a complete understanding of the safety and performance of a medical device, ensuring its suitability for use and protecting public health.
What information must be reported on annex i clinical evidence?
Annex I clinical evidence must include details on the device's design, intended use, clinical evaluation, risk assessment, post-market surveillance, and any significant changes made to the device throughout its lifecycle.
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