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.
FDA
The article highlights the key points related to the regulatory framework for remanufacturing medical devices, outlining the main considerations and critical aspects.
HPRA
The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
Australia
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
