The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.
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.
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
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