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What Next For Standards As CEN/CENELEC Reject MDR/IVDR Commission Request?

 
• By Amanda Maxwell

The timetable for developing harmonized standards under the EU’s Medical Device Regulation was already tight, even with new 2021 MDR application date. But it now looks untenable, even for the most urgently needed standards.

Blocked

European standards bodies CEN and CENELEC were due to submit their joint work program to the European Commission today. But that is not happening.

The standards bodies rejected the European Commission’s Medical Device Regulation (MDR) and IVD Regulation (IVDR) standardization request on 16 June, creating a major setback for one of the

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• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

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• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

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

Communication with patients has become a particularly crucial factor for investors, payers, and other healthcare decision-makers in a hostile market environment.

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.