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As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...
The introduction of new Post-Market Surveillance regulations and UKCA marking processes presents key opportunities for medical device manufacturers to align compliance strategies and enhance market ...
Our recent briefing note (available here) explained that CE product safety marking, which is required to sell certain types of goods in the European Union, was being replaced by the UKCA mark in Great ...
The UK government recently announced an indefinite extension to the use of CE marking for most goods. The extended recognition of CE marking does not, however, apply to medical devices. That said, the ...
SPINEstat™, a novel, first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), has received UKCA marking and is now listed as an IVD in the United Kingdom. This milestone expands ...
DALLAS, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Spectral MD, Inc. (“SMD”), a subsidiary of Spectral AI, Inc. (NASD: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company ...
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