Under EU medical device directive 93/42/EEF, all medical device manufacturers not registered in the EU mush designate an EU Authorized Representative.
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What is Eudamed?
Learn more about the new European Databank on Medical Devices and its role in strengthening market surveillance and transparency across the EU.
NB-MED Performed a survey on IVDR Readiness of the Notified Bodies
Read more about the results of NB-MED's 2019 survey on the readiness of Notified Bodies for the new In-Vitro Device Regulation in Europe.
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Support Point-of-Care Scanning of UDI Data for Implantable Devices: new GS1 guidance
Standards development body GS1 issues implementation guidelines for point-of-care UDI data scanning support for implantable devices across Europe.
K-REACH Pre-registration Started from 1st January 2019!
Amendments to the Korea Reach act will have implications for chemicals being imported and exported to Korea. It enters effect on January 1st 2019.
Canadian medical device legislation develops in the same direction as EU MDR
Canada adopts risk-based approach to medical device legislation to increase safety and effectiveness. This is in keeping with new EU medical device regulation.
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Regulatory news and updates from Obelis. Your source for up-to-date information on developments in EU regulations, directives and compliance standards.