
Update on Notified Bodies designation under MDR / IVDR
The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task...

EC Acts Quickly – and issues proposal to delay MDR deadline amidst COVID Pandemic
With sweeping speed, the European Commission (EC) has issued its proposal to postpone the deadline of the transition from MDD to MDR. The goal is to have the European Parliament...

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...