North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
Europe
HDR UK will release seven new health data hubs, providing over 100 doctors, scientists, and researchers with the medical histories of millions of NHS patients. They aim to aid research for new medicines, treatments, and technologies across the country, HDR’s...
North America
The FDA finalized guidance regarding the use of placebos and blinding during randomized cancer trials. The guidance finalizes a draft made in 2018 and clarifies scenarios where placebo designs and blindings should be justified. WHAT IS A PLACEBO? A placebo is an inert...
Europe
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation. However, there are slight differences in the regulatory...
Europe
Medical devices in the EU, including Hungary, are classified into four classes based on their risk: I, IIa, IIb, and III. Medical devices belonging to Class I are associated with the lowest risk to the human body, while Class III devices are associated with the...
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