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31

May 2022

ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
ALERT: New European Union In Vitro Diagnostics Regulations (EU IVDR) to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC)
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The new European Union In Vitro Diagnostics Regulations (EU IVDR) entered into application on May 26, 2022, to replace In Vitro Diagnostic Medical Devices Directive (98/79/EC). Manufacturers, authorized representatives, importers, and […] Read More >>

13

May 2022

EU In Vitro Diagnostic Medical Device Regulation
EU In Vitro Diagnostic Medical Device Regulation
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In vitro diagnostic medical devices contain a broad spectrum of devices that test biological samples to determine the status of one’s health, from self-tests for pregnancy, to blood glucose tests […] Read More >>

29

Apr 2022

What You Need to Know about EFSA Strategy 2027
What You Need to Know about EFSA Strategy 2027
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EFSA’s Strategy 2027 delineates the European Food Safety Authority (EFSA) strategies and approaches in responding to the changing environment in the years ahead, especially in light of the SARS-CoV-2 global […] Read More >>

14

Apr 2022

How to Get a CE for a Medical Device
How to Get a CE for a Medical Device
By
Medical devices in the European Union (EU) are approved through a different mechanism than the approval process in the United States or Canada. The approval of medical devices intended for […] Read More >>
dicentra is now a Proud Sponsor to Europe NOW
June 30, 2012 By
Contact us to book a meeting or drop by our booth to discuss how dicentra can help you with your regulatory and scientific affairs concerns. dicentra provides regulatory and scientific […] Read More >>
dicentra’s Q2 Regulatory Update Webinar is now available online
June 19, 2012 By
dicentra’s Regulatory Update Webinar – Q2 dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and […] Read More >>
Successful EU response to BSE
February 5, 2012 By
By: Arwen Brooks – Quality Assurance and Regulatory Affairs Assistant February 6, 2012 BSE – a crisis in Europe and worldwide In the past two decades, Bovine Spongiform Encephalopathy (BSE) […] Read More >>

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