March 27, 2020

[FEATURED] Commission Firm on MDR Deadline But Could COVID-19 Emergency Measures Alter Date?

As COVID-19 begins to hamper EU Medical Device Regulation preparations, questions are being asked about whether the regulation might now be delayed. Medtech Insight spoke to top experts to find out more.

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December 18, 2019

[FEATURED] CE Featured Article BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow

There is not much demand currently for testing against the EU’s Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?

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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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September 12, 2019

[FEATURED] Global Call To Rethink MDR Timing Sees Commission Dig Heels In Further

The calls for a delay in the implementation of the new EU MDR are becoming increasingly loud on the international front, with the US, for one, wanting to see a three-year postponement. Is the European Commission right to remain stubbornly attached to its deadline?

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August 7, 2019

[FEATURED] Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents

The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.

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[WEBINAR] How to Assess Your CER for MDR Readiness Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.