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It has been just over three years since the respective notification procedure to the European Commission (reported here), the Portuguese...
Cortex - Life Sciences Insights
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On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses...
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This week our specialist AI team launched a fantastic new report on AI Governance. The report is based on an original survey of 600...
As of March 28, The Italian Council of Ministers have approved the new Public Contracts Code. The Legislative Decree No. 36 of March 31,...
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With Law Decree no. 34/2023, the Italian government has approved significant changes to the Italian medical devices payback system for...
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As part of the MHRA’s Software and AI as a Medical Device Change Programme, the MHRA has recently published guidance on crafting an...
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A much-awaited extension of the MDR transition period became effective today with the publication of Regulation (EU) 2023/607 in the...
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In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...
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Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical...
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As previously shared when the new regulatory framework for software as a medical device (“SaMDs”) was presented earlier this year (here),...
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Italy enacted legislation to adapt the national framework governing medical devices and in vitro-diagnostic medical devices to the MDR...
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The European Commission recently adopted two new regulations laying down rules for the application of Regulation (EU) 2017/746, as...
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On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the "Act"). It was signed by the President on 20...
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HealthTech: Trends and Challenges In a recent internal webinar, DLA Piper and Global Data looked into the shifting landscape of...
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In late February, 2022 the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical...
