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Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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Understanding the EU IVDR white paper by Emergo by UL
Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
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Register: Eudamed Webinar July 2018
WATCH NOW: Eudamed Requirements under the EU MDR and IVDR
As it prepares to meet new regulatory requirements in Europe, the medical device community is also following developments about the European Database
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EU IVDR readiness checklist from Emergo by UL
EU IVDR Readiness Assessment Checklist
Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)? Under the IVDR, in vitro diagnostic (IVD) device
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Emergo MDR webinar October 2017
WATCH NOW: The new European Medical Devices Regulation (MDR 2017/745)
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect for a
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How ISO 13485:2016 Impacts Medical Device Companies
ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also
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EU MDR delay white paper
MDR One-year Delay: Implications for medical device manufacturers
In February 2020, the first European countries began to be affected by the COVID-19 virus. During March, the rest of the pack followed and Europe
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EU mdr delay
MDR Transition: Countdown to compliance
When the European Medical Devices Regulation 2017/745 (MDR) takes effect, it will transform the regulatory system that governs the world’s second-
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Register for our free webinar on choosing or changing your EU Notified Body
WATCH NOW: How to Select or Change Your EU Notified Body
European Notified Bodies are under intense scrutiny by Competent Authorities, and that oversight has filtered down to their clients. A few years ago
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