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.
EU
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
HPRA
The new article describes in detail the requirements in-house IVDs are subject to.
HPRA
The new article elaborates more on the specific frameworks applicable to in-house IVDs allowed for manufacture and use in Ireland.
HPRA
The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
