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.
EU
The new article elaborates further on the aspects related to risk management in the context of medical devices to be used in the course of clinical investigations.
EU
The new article clarifies the aspects related to the pre-clinical evaluation the device should undergo before it will be allowed for use in patients.
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