Sep 20, 2023
MHRA
The new article highlights the aspects related to placing certain medical devices on the market with the respective CE certificates expired or expiring soon. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),the UK regulating...
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Sep 19, 2023
MHRA
This article addresses the aspects related to the extensions to the timelines introduced in order to allow marketing products before compliance with the new regulatory requirements will be achieved. Table of Contents The Medicines and Healthcare Products Regulatory...
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Sep 15, 2023
MHRA
The article provides a general overview of the regulatory requirements for the registration of new medical devices relying on CE certificates that are either expired or about to expire. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),...
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Aug 11, 2023
IMDRF
The new article describes in detail additional controls to be implemented with respect to medical devices that are no longer supported by their manufacturers. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary association of...
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Aug 11, 2023
Europe
The new article highlights aspects related to electronic submissions and specific types of products. Table of Contents The Swiss regulatory authority in the sphere of healthcare products (Swissmedic) has published a guidance document dedicated to the regulatory...
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