IVDD

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Harmonised Standards for MDR? CEN/CENELEC say “Non”

Back in November 2019, looking at the virtual break down in harmonisation of standards to the European Directives and the belated request from the Commission for harmonisation to MDR of...
Brexit

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

As the dust settles on the UK general election, it appears that Brexit is inevitable, it's only a matter of short term timing and terms. So what does this mean...
Standards

Are Harmonised Standards facing irrelevance?

There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR).  And rightly so. But harmonisation is already in disarray...

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