EU
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
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.
Austria
The article provides a general overview of the regulatory framework for combination products applicable in the EU in general and in Austria specifically.
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