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Commission Publishes Implementing Regulation That Acts As Basic Starter Manual For Eudamed

 
• By Amanda Maxwell

The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.

Regulation cogs (EtiAmmos/Shutterstock.com)

The Implementing Regulation laying down rules for the application of the MDR as regards Eudamed details the processes that actors must go through to obtain access to the European medical device database, explains that authorized users should use the free-of-charge European Medical Device Nomenclature codes when accessing the database, and details what help and training will be available.

In addition, it covers what happens if fraudulent activity, malfunctions, or if security risks are identified.

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MHRA’s Tallon Lays Out His Philosophy On Healthcare Products Regulation

 
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June Raine was a “hard act to follow” at MHRA, but new chief executive Lawrence Tallon is looking to the future in setting out a vision for the UK regulator.

As Medtech Tariffs Loom, AdvaMed Responds With Its Own Plan Emphasizing ‘Reciprocal’ Free Trade

 
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The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.

German Medtechs Choking Under EU Compliance And Reporting Obligations Tout Mutual Recognition

 
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Industry survey points to ongoing low revenues rise and weaker profit levels for half of BVMed industry association members in 2025, as German manufacturers raise stakes on global harmonization.

Fixing The Fractures: New Aspirations For EU Medtech Regulatory Progress

 
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A pioneering initiative, Edvance MedTech, is being launched by leading experts in medical technology regulation which aims get to the heart of what is needed to improve the way EU rules are not only applied but also decided.

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Medicare’s TCET Pathway Wins Acclaim From Early Users, Even As ‘Messy Middle’ Persists

 
• By Brian Bossetta

Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.

German Medtechs Choking Under EU Compliance And Reporting Obligations Tout Mutual Recognition

 
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Industry survey points to ongoing low revenues rise and weaker profit levels for half of BVMed industry association members in 2025, as German manufacturers raise stakes on global harmonization.

Fixing The Fractures: New Aspirations For EU Medtech Regulatory Progress

 
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