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Eudamed - A Moving Target But On Track For March 2020 Partial Go-Live

 
• By Amanda Maxwell

While Eudamed is largely on track, there could be a few months of delay in the availability of certain critical parts of the EU's updated medical device database. Stakeholders are working toward a May 26, 2020, deadline for the full application of the EU Medical Devices Regulation, including Eudamed.

Arrow

Modules for clinical investigation and market surveillance might be only “partly or not at all available” at the time of application of the two EU medtech regulation (the MDR, and its sister IVDs regulation in force two years later), and not fully operational until few months after the respective deadlines. This is due to “workability issues,” the European Commission says in its Rolling Plan.

The plan was updated recently, without fanfare, on the Commission's website

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More from Europe

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• By Ashley Yeo

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Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

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Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

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More from Geography

Bringing Israeli Medical Device Candidates To The Right Partners In The US

 
• By Ashley Yeo

Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.

How Structured Patient Engagement Gives Medtech Companies A Competitive Edge

 
• By Amanda Maxwell

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Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.