EU Updates MDCG 2023-3 Guidance on MDR & IVDR Vigilance
The European Commission has published an updated version of the MDCG 2023-3 Rev.1 Questions and Answers on…
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MDCG 2022-5 Clarifies Sterilization Products for Medical Devices
The Medical Device Coordination Group (MDCG) has issued an important update to its guidance on the borderline…
AEMPS Launches New App for Hospital-Made Medical Devices
The Spanish Agency for Medicines and Medical Devices (AEMPS) has launched a new digital platform that enables…
New TGA Guide for Submitting a CMMD Notification
TGA has released a new update on how to submit a Custom-Made Medical Device (CMMD) notification. This…
Swissdamed to Align with EUDAMED XML Format
Swissmedic has announced that the Swissdamed registration system will use the same XML file format as EUDAMED for its…
New Guidance on EtO in Medical Device Sterilization
The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2024-13,…
Defining Medical Device vs Medicinal Product | MDCG 2022-5
The Medical Device Coordination Group (MDCG) has released a revision of the MDCG 2022-5 guidance, which…
New EU Guide | Medical Device Supply Interruption
The European Commission has released a comprehensive Q&A guide to clarify new reporting obligations regarding the supply interruption…
EU Parliament Urges Revision of MDR and IVDR
The European Parliament has published the adopted text of a resolution entitled ‘Urgent need to revise the medical…
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