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MDR Is The ‘Mother Of European Industry’s Problems’ − Germany's BVMed At Medica 2023

One in 10 German medtechs will not survive the €7bn+ journey to EU regulatory compliance

 
• By Ashley Yeo

Higher logistics and energy costs are putting medtech P&Ls under pressure, and compliance with the EU MDR is draining any remaining surplus. Sustainability compliance is another cost to factor in, says BVMed chief executive Marc-Pierre Möll in part 2 of his interview with Medtech Insight at Medica 2023. 

Boulder

Germany’s medtech companies have finally achieved a reasonable rise in annual revenues, with averages of 5-7% being recorded by some of the bigger players recently. SMEs are seeing increases of 3-4%.

This is a welcome return to some sort of stability after the financial pressures and business disruption of the COVID period. But the picture for the bottom line is still...

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More from Germany

A Deregulated Medtech Sector Could Flourish In Merz’s Industry-Friendly Germany

 
• By Ashley Yeo

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
• By Ashley Yeo

Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By Ashley Yeo

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.

More from Europe

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• 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.