HPRA
The article provides a general overview of the regulatory requirements applicable to medical devices created and manufactured by healthcare institutions to meet their own internal needs.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
EU
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
EU
The new article further elaborates on the key matters associated with substance-based products intended to be marketed and used within the EU.
EU
The new article describes in detail the regulatory status of herbal products.
EU
The article outlines the key points related to the regulatory framework for borderline products.
