The MDR Transition: Key Insights for MDR Certification Renewal
During RAPS Convergence 2024, one of the main topics on the agenda was the status of the transition from MDD…
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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…
Webinar: Regulatory Importer Responsibilities & Best Practices
This webinar has now expired: To Download The Full Presentation Click…
Great Britain Medical Device Registration
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), under the jurisdiction of the UK Department of Health and…
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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