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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Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease
Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.
How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance
UTIs are one of the most common reasons for antibiotics to be prescribed, but accurate and timely diagnostic tools are lacking. England’s NICE has identified four innovative IVDs that could be rolled out for NHS patients, but said more research is needed on these products first.
EU MDR Notified Bodies Reach 38 After Another Designation
Germany’s SZUTEST is the latest notified body to be designated under the EU Medical Device Regulation, bringing the total number to 38.