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Notified Bodies

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Sertio Oy designated as EU Notified Body

Sertio Oy from Finland is designated as a notified body under the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVDR). To date, there are twelve notified bodies designated under the EU IVDR. This designation was published on NANDO database on 31 October September 2023. This can be considered as significant news to the European diagnostics industry.
admin
November 3, 2023
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MHRA increases UK assessment capacity for IVDs

MHRA has confirmed that UL International UK Ltd is now designated to assess most IVDs, increasing the UK’s capacity to process conformity assessments. UL International UK Limited have had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices, adding to the capacity already provided for these types of products by BSI…
Ben Kemp
January 27, 2023
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