Under a new Conformity Assessment Procedure issued by the Mexican Federal Telecommunications Institute (IFT, as per its acronym in Spanish), effective February 25, 2021, the Certificates of Conformity ...
Hamilton, Bermuda, May 25, 2021 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, ...
The Board of the Eurasian Economic Commission has adopted changes to the Procedure for forming and maintaining a unified register of issued certificates of conformity and registered declarations of ...
In Part 2 of our ‘Battery Shorts’ series, we look at the conformity assessment and CE marking requirements under the new European Union Batteries Regulation, which have applied since 18 August 2024.
*This article was updated to specify the scope of the conformity assessment procedure. The EU lawmakers leading on the AI Act have circulated revised compromise amendments on how AI systems that could ...
The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000. 1 It provides Europe with one single regulation for in vitro ...
Currently, both existing CE-mark devices and devices hoping to be sold in the European Union (EU) face major challenges in the conformity assessment procedure for market access. During his session, ...
On this topic, Dr. Christian Krey, CEO of EMPERRA ®, comments: The further development of the already commercially available insulin-data transferring ESYSTA Smartpen to a Bluetooth enabled insulin ...
To begin with, confirmation is made of whether the electrical products correspond to "electrical appliances and materials" in the scope of the Act. Generally, products and parts that are connected to ...
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