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BSI has adopted standard for electrical safety

BSI have adopted IEC 61010-2-101:2018 as a British standard. BS EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment considers electrical safety requirements for IVD equipment, and should be considered for manufacturers with products in this space.
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May 5, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 24 Apr)

Please note this is an extract of the original bulletin. Reporting to the National Supply Disruption Response (NSDR) Page summary: Information on how to request assistance from NSDR. Change made: Updated language used from ‘how to report’ to ‘how to request assistance’ to describe the service more accurately. Lateral flow device (LFD) performance data Page summary: LFDs have proved vital…
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May 5, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 17 Apr)

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
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April 28, 2023
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