MDCG
The new article provides an overview of the regulatory status of accessories and related products as set forth under the existing legal framework.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
European Commission
The new article describes in detail certain specific aspects to be taken into consideration by the parties involved in order to ensure the important information is duly communicated in accordance with the relevant regulatory requirements.
European Commission
The new article provides additional clarifications regarding the specific scope of information-related obligations medical device manufacturers should comply with.
European Commission
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
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