Friday, May 26, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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4.8.1 EU Directives

The only circumstances where it can be justified that requirements not followed is where a decision is based on risk assessment by the Responsible Person. Otherwise you have to follow all aspects of the EU directives. Sometimes you have to investigate further and therefore you are required to use risk assessments. But this is mainly medical risk assessment, which every doctor performs on a regular basis. The risk management which is being described in this paragraph of the Good Tissue Practices focuses mainly on Quality risk management. 

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