EC Guidance Document Details Notification Process For Clinical Investigation Reports

The Medical Device Regulation requires sponsors of clinical investigations to file a summary of their report shortly after study completion. The commission explains the steps and the need for conciseness.

Summary

The European Commission has published a new guidance document on the content and structure of the summary of the clinical investigation report in the context of the Medical Device Regulation.

More from Europe

More from Geography

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

 
• By 

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

 

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 

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.