medical devices

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Expedite! Emergency device regulatory approvals in a pandemic

These are difficult times – and we need fast, really fast, regulatory reviews. So how does this work – how have regulators adapted to the COVID-19 pandemic? What new and...
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...
Brexit Aus image

And out they go…BREXIT is final! But what about Australia?

After several years of leadership changes, elections and conspiracies, we’ve finally arrived at the exit gate. Effectively, with no deal being reached, the implications to the UK are significant, however...
Process copy 2

A single review program for medical devices?

During this year’s Bio-Utah Summit in November 2019, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) spoke about the new initiatives and modernization of...
Door closed

The door to Europe is closed – so where else should I look?

Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
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...
Stairs with light

The question on clients’ lips… “How long will my application take?”

Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. On the 21 October 2019, The TGA released the latest annual statistics on...
End of financial year

Out They Go – FDA Clears the Store of Guidances

In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of...
Red carpet

FDA Fashion Parade – Guidance Priorities for Fiscal 2020

Each new fiscal year, FDA sets out its priorities for guidance development and publication over the coming year. It’s always a fascinating insight into the current regulatory fashions, and just...
Implant

Custom Devices, Clinical Trials and the Hazards of Precedent

This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...

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