EU Borderline Product Court Ruling Puts Tricky “Negative Burden Of Proof” On Manufacturers
When is a borderline drug/device product a medical device? Only when the manufacturer can prove that is definitely not a medicine, according to a new EU Court Of Justice ruling. Expert medtech regulatory lawyer Erik Vollebregt outlines his main criticisms of this judgment.
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The regulation of products on the drug/device borderline has always been complex. New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.
Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease
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How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance
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