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…
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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…
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:…
Swissmedic Updates: New Timelines & Label Requirements
On the 20th of November 2024 Swissmedic communicated a new press release regarding a few amendments to the Ordinance on…
HPRA Announces Review of Proposed Fee Increases After Public Consultation
The Health Products Regulatory Authority (HPRA) Ireland has unveiled revisions to its proposed fee structure following a…
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