Tag Archives: Focus Article

Christian Götz and Dr. Jara Brenke

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

By Christian Götz, Dr. Jara Brenke
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Christian Götz and Dr. Jara Brenke

Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.

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Amanda Bloom
Soapbox

MedTech Marketing Pearls for FDA Clearance and Beyond

By Amanda Bloom
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Amanda Bloom

As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.

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Vishnu Kalra

Partnering to Support Sustainability in the OR

By MedTech Intelligence Staff
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Vishnu Kalra

A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President, U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how other companies can get started.

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