October 5, 2020

[FEATURED] Industry Awaits Commission Ruling On Virtual Audits Under MDR

Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.

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August 25, 2020

[FEATURED] Unprecedented Number Of EU Medtech Guidance Documents Now Available On New Commission Website

The European Commission’s output of guidance documents over the last few months has been extraordinary, and unprecedented. A new website gives users access to all these documents and shows what has changed.

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September 25, 2019

[FEATURED] It Is A Great Time to Move Within Regulatory – Especially If You Know What To Expect

The demand to fill EU regulatory roles is at its peak and is dictating the very nature of employment in the medtech sector. Amanda Maxwell spoke with recruitment expert Elena Kyria to hear her views on how to maximize the unique opportunities that currently exist. This is Part 1 of a three-part interview series on recruitment in medtech. 

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August 29, 2019

[FEATURED] EU MDR: Handful Of Additional Notified Body Designations Await Go-Ahead

Recent indications from the European Commission led EU medtech stakeholders to believe that more notified bodies would have been designated by now. Not so, and the lack of any visible progress means that, for manufacturers, nerves will start to jangle again before long.

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July 25, 2019

[FEATURED] Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices

Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?

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