May 31, 2020

[FEATURED] MDR Or MDD: Which Route Should You Choose Now That The MDR Is Delayed?

With the recent EU decision to postpone the Medical Device Regulation by a year, what factors do medtech manufacturers need to consider when deciding the time to submit applications?

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May 20, 2020

[FEATURED] EU COVID-19 Response: Who Is Leading EU’s Decision-Making For Medtech?

The COVID-19 pandemic has meant seismic shifts in the way the EU has been operating to regulate and procure emergency equipment needed on the frontline. Unprecedented changes have been required, but how did the EU achieve this so quickly and how has its reaction impacted central decision-making and how member states work together?

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May 3, 2020

[FEATURED] Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities

Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.

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April 13, 2020

[FEATURED] European Commission Recommends Regulatory Midway For COVID-19 Products

The EU is addressing the regulatory obstacles that threaten to reduce the speed at which vital products needed to treat COVID-19 are produced.

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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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[WEBINAR] Live Q+A for ‘Assess Your CER for MDR Readiness, Part 1’ with Laurie

We had a large turnout at our webinar on April 29, 2020, “How to Assess Your CER for MDR Readiness, Part 1 : State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review.” We ended with many unanswered questions. To answer these and more questions, President Laurie Mitchell is coming back to host a Question & Answer session LIVE.

Jun 4, 2020 11:00 AM in Pacific Time (US and Canada)

Click here to register for this free webinar