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Effective URL: https://medtech.citeline.com/MT147986/Is-The-Implementation-Of-The-EU-Medtech-Regulatory-Structure-Entering-A-New-Phase
Submission: On April 05 via manual from US — Scanned from DE
Effective URL: https://medtech.citeline.com/MT147986/Is-The-Implementation-Of-The-EU-Medtech-Regulatory-Structure-Entering-A-New-Phase
Submission: On April 05 via manual from US — Scanned from DE
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Acccess Token : Refresh Token : Entitlement Claim : We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By continuing to use the website, you consent to our use of cookies. Medtech Insight is part of Pharma Intelligence UK Limited * * * * This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group. Informa Toggle Menu Menu My View Other Products: In Vivo | Pink Sheet | HBW Insight | Scrip | Generics Bulletin Start Trial Sign In This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183 Printed By UsernamePublicRestriction Existing Subscriber? Sign in to continue reading. Sign In New to Medtech Insight? Start a free trial today! 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What does this mean for the sector? YOU MAY ALSO BE INTERESTED IN... MEDTECH FORUM 2023: EUROPE’S REGULATORY MAZE MUST BE SIMPLIFIED, BUT HOW? Navigating Europe’s increasingly complex maze of regulations was the topic du jour at this year’s MedTech Forum conference. Despite growing concerns that the EU is losing its historic attractiveness for companies, a spirit of resilience characterized the busy three-day meeting. FEW HIGH-RISK DEVICES SUBJECT TO EU’S GREATEST LEVEL OF SCRUTINY Just four devices were subject to a scientific opinion from an expert panel in the second year of reviews, compared with six in the previous year. FRESH OPPORTUNITY FOR FREE SCIENTIFIC ADVICE FOR HIGH-RISK DEVICES FROM EU EXPERT PANELS The EMA is extending the pilot phase of the EU’s scientific advice program and inviting a third round of applications by mid-2024. Existing Subscriber? Sign in to continue reading. Sign In New to Medtech Insight? Start a free trial today! Free Trial Slowdown in publication of official EU level medtech regulation documents Table View full table Advertisement TOPICS * Regions * Europe * Blocs * EU * Subjects * Compliance * Policy * Regulation Advertisement * Ask The Analyst * Email * Print * PDF * Bookmark * Share Tags: Europe EU Compliance Latest Headlines * 05 Apr 2024 FEW HIGH-RISK DEVICES SUBJECT TO EU’S GREATEST LEVEL OF SCRUTINY * 05 Apr 2024 GERMAN IVDS AT THE TURNING POINT: DIGITAL AND AI SHOW FUTURE MARKET DIRECTION * 04 Apr 2024 AUSTRALIA CUTS REGULATORY BURDEN OF PRODUCT RECALLS * 03 Apr 2024 REPORT SAYS VHA NEEDS BETTER IMPLANT TRACKING See All YOU MUST SIGN IN TO USE THIS FUNCTIONALITY Sign In AUTHENTICATION.SIGNIN.HEADSIGNINHEADER Sign In UsernamePublicRestriction REGISTER Your username does not meet the requirements. Sorry - this email domain is not allowed. Sorry - public email accounts are not allowed. Please provide a work email address. An account with that username already exists. 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