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in vitro diagnostic medical devices (IVDR)

Vicki Anastasi, and Karen Hill, ICON, examine the key challenges associated with the new EU MDR and IVDR. more

Features

With Brexit looming, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS) discusses how medical device companies should respond to the EU's new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). more

News

Brian Moan, director of Solutions Delivery Europe and Norm Rabin, director of Solutions Delivery at Maetrics write about what to expect from the new IVDR regulatory framework. more

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Sheena Linehan, patent attorney at IP law firm Potter Clarkson talks about the new EU medical devices regulations and why IP strategy needs refreshing. more

Global public health and safety organisation NSF International recently completed the acquisition of Prosystem, a German medical device consulting firm specialising in regulatory affairs and clinical evaluation. more

News

Here’s ten things you really need to know about the new European Medical Device Regulation. more

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An introductory guide has been made available by the Medicine and Healthcare products Regulatory Agency (MHRA), so manufacturers are aware of requirements under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). more

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The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR). more

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The Centre for Process Innovation (CPI – stand 47) will be discussing a range of emerging and enabling technologies including printable electronics, sensors, photonics, nanotechnologies, formulation science, new materials and biotechnology. more

Expo News

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Alexandra Lande / Shutterstock.com

The medtech sector has welcomed the vote from the European Parliament to endorse new regulations on in vitro diagnostic medical devices (IVDR) as well as the new Regulation on Medical Devices (MDR). more

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