What’s Happening in the UK and Switzerland The implementation and extensions of EU MDR/IVDR have caused significant stress on regulatory departments. These challenges have been compounded by Brexit and the UK’s announcement that it would not adopt EU MDR/IVDR and the Swiss National Council’s vote to allow FDA-approved devices into the Swiss market. During …
Swiss National Council Votes To Accept FDA Approved Medical Devices On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to accept medical devices with FDA approval. Since 2001, healthcare providers and patients in Switzerland have only had access to medical devices with an EU certificate. Swiss MedTech, …
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Veranex Acquires Medidee Veranex, a global, tech-enabled service provider dedicated to the medical technology industry, has acquired MedTech consultancy Medidee, headquartered in Lausanne, Switzerland. The acquisition will expand and strengthen Veranex’s regulatory affairs, clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience …
