EU industry challenges hip implants upgrade proposal
This article was originally published in Clinica
Executive Summary
The formal request put forward by the French and UK medical device regulatory authorities to reclassify hip joint replacements as high risk products (see Clinica No 1045, p 3) could impact the availability of these products to patients in the short term and constitute an unnecessary burden on the European medical technology industry. That is the view of the European medical devices industry association, which has issued a statement challenging the nature of the request.
You may also be interested in...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.