BfArM
The article outlines the key points related to reporting serious adverse events in the context of clinical trials.
Great Britain
The article provides a general overview of the UK regulatory framework for clinical investigations related to medical devices intended to be marketed and used in the country.
EU
The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
EU
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
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