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Updated Notified Body Conduct Code Explains Permitted 'Structured Dialogue'

 
• By Amanda Maxwell

There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document gives useful insights.

Team-NB, the EU industry association for notified bodies, has issued the latest version of its code of conduct under the Medical Device Regulation (MDR) and the IVD Regulation for its members. This is the fifth edition.

One particularly interesting update to the document is a page citing what can be and cannot be provided in the...

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June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
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June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
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New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.