The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
RegDesk Regulatory Roundup
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
The article provides a general overview of the current regulatory framework for the distribution and advertising of medical devices intended to be marketed and used in Turkey.
The article outlines the scope of information to be included in premarket submissions depending on the sterilization methods used.
The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.