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...
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...
Some Class I Device Transitions Extended – MDR
Under growing pressure from industry and notified bodies, the need to provide some breathing space around MDR deadlines by the European Commission has finally been considered. After much focus on...
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 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...
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...
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...
Make your transition from MDD to MDR – White Paper
With less than one year remaining for the transition to the Medical Device Regulation (MDR), this white paper takes a look at the key areas to be addressed for manufacturers...
And so starts the MDR/Brexit fallout… First LRQA and now QS Zurich fall by the wayside
Breaking News: As of June 13th, Lloyds Register Quality Assurance (LRQA) withdrew from MDD and IVDD services (see the announcement here). It's official, the first notified body based in UK...
Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…
Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...