MDR

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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...
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TGA deploys Post Market Review Compliance Dashboard

Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
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TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response...
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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...
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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...
Deadline extended

MDR – Some Class I Device Transitions Extended

Under growing pressure from industry and notified bodies, the need to provide some breathing space around Medical Device Regulation (MDR) deadlines by the European Commission has finally been considered. After...
Clearing fog

TGA acceptance of international device reviews – clearing the fog

A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices....
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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TGA Publishes updated MDIR Guide

Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events in Australia (Medical device incident...

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