MHRA Updates Guidance on Serious Adverse Events Reporting
The Medicines and Healthcare products Regulatory Agency (MHRA) issued an important update to its Clinical Investigation Guidance, with a…
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FDA Issues PCCP Guidance for AI Medical Devices
The FDA has issued an official guidance (December 2024), related to AI enabled device software marketing submissions and PCCP (Predetermined…
MDCG Guidance: Publishing Clinical Investigation Reports
The Medical Device Coordination Group (MDCG) has issued a new guidance titled ‘Guidance on the publication of the clinical investigation…
Master UDI-DI Solution for Contact Lenses Guidance
Today the Medical Device Coordination Group (MDCG) has released the MDCG 2024-14 guidance document, which provides essential information…
Team-NB Releases AI Questionnaire on MDR and IVDR
Team-NB has released a position paper and a questionnaire with IG-NB addressing the integration of…
FDA High-Risk Medical Device Recall Pilot Expedites Alerts
The FDA medical device center is announcing a pilot program aimed at expediting public and healthcare provider…
ISO 13485 Medical Devices: Global Regulatory Compliance
ISO 13485:2016 standards play a fundamental role in global regulatory compliance for medical devices. Nearly 30 years after the initial…
EUDAMED Roll-Out: New Q&A Document Under MDR and IVDR
A Q&A document was published outlining the practical aspects of the gradual roll-out of EUDAMED pursuant…
TGA IVD Sponsor Roadmap: Key Links & Steps for ARTG Inclusion
TGA (Australian Register of Therapeutic Goods) in Australia have updated a reference material called: “IVD sponsor:…
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