EU
The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
EU
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
Great Britain
The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
Great Britain
The new article describes in detail the new regulatory policy for in vitro diagnostic medical devices as suggested by the UK authority.
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