EU
The article highlights the key points related to the regulatory status of legacy devices.
EU
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
MDCG
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
MDCG
The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.
MDCG
The new article provides an overview of the regulatory status of accessories and related products as set forth under the existing legal framework.
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.
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