MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.
The UK's National Institute for Health and Clinical Excellence has created a new program to evaluate innovative technologies and plans to assess Genedrive's MT-RNR1 test for antibiotics-induced hearing loss in infants via this new process, the company said on Monday.
UK-based startup Tailor Bio has received £650,000 ($771,767) through the Innovate UK Biomedical Catalyst Award in support of its ambitions to develop a pan-cancer precision medicine platform.
C2i Genomics launches minimal residual disease test across Europe after clearing regulatory hurdles in the EU, UK, and Switzerland.
Roche Diagnostics has launched its new molecular laboratory instrument, the cobas 5800 System, in the UK. Through improved automation, the new system can help raise testing volumes, improve operational efficiency, and manage the increasing demand that many laboratories are experiencing, Roche said.
Kent, UK-based point-of-care test developer Psyros Diagnostics on Thursday announced it is being acquired by Prolight Diagnostics, based in Lund, Sweden, for SEK 65 million ($7.1 million).
UK molecular diagnostics company Genedrive said on Wednesday that its rapid molecular COVID-19 test has received CE marking.
French diagnostics firm Novacyt said last week that its Genesig COVID-19 Real-Time PCR assay has been approved in the UK under newly implemented regulations on SARS-CoV-2 tests.
Companies that have already registered their devices in the EU will still be able to sell their products in Great Britain until June 2023. From this point, they will be required to register their device for UK Conformity Assessed (UKCA) marking.
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