MDR

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The EC confirms they are working on a proposal to delay MDR deadline amidst COVID Pandemic

On 25 March 2020, the EU Commission, issued a formal communication that they are preparing a proposal to postpone the MDR implementation deadline. This would be a welcome respite for...
Deadline extended

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...
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...
Magnifying glass copy

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...
Transition

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...
Train-derailing

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...
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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...
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Fog in the Channel: a European Medtech Perspective on Brexit

An apocryphal newspaper headline reported, "Fog in the Channel - Continent Cut Off". All very whimsical and a metaphor for a peculiarly anglo-centric world view. But as the UK stumbles...

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