MHRA Introduces PMS Update to UK Medical Device Regulations
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the first significant update to…
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ARTG User Guide Updates for Custom & PMMD Devices
User guides have been updated to include the transition eligibility content. While custom made devices are now exempt from requirement…
Update to MDCG 2021-25: Key Clarifications on MDR Transition
The MDCG 2021-25 (Rev1.0) has been updated, reflecting the latest developments in the MDCG MDR Transition. The guidance now takes…
Understanding the Role of Notified Bodies in MDR Compliance
Similar to the role of Economic Operators, it is important to recognize that Regulation (EU) 2017/745 (MDR) includes a…
The IGJ Highlights the Importance of an Effective PMS System
The inspections conducted by the Healthcare and Youth Care Inspectorate (IGJ), based in the Netherlands, focused on evaluating manufacturers’ adherence to Post-Market…
Australia 3G Shutdown in Oct 2024 May Impact Medical Devices
The decommissioning of 3G networks in favor of more advanced 4G and 5G networks may affect medical devices and products…
MDCG Guidance Clarifies IVDR Product Classification and Scope
Despite over a year having passed since publication of Version 3 of the Manual on borderline and…
The Essential Guide to EU MDR Medical Device Classification
Early device classification is essential, especially if you have a complex…
MDCG Guidance on CAPA Plan Assessment for Notified Bodies
The MDCG (Medical Device Coordination Group) has released a guidance document titled “Corrective and Preventive Action (CAPA)…
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