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EU MDR One Year Out: Reg Demands Forcing European Business Closures

 
• By Ashley Yeo

The impact of high regulatory demands on the innovation potential of medtech companies in Europe was a sub-theme of last week’s MedTech Forum in Paris. But it’s not a theoretical risk, for coinciding with the Forum was a decision by Swiss company Jossi Holding to close its orthopedics subsidiary.   

Quitting

Ten years after being spun out from Swiss medtech custom precision instrument maker Jossi AG, the sister company set up to exploit the orthopedics market, Jossi Orthopaedics AG, will be closed this year. The decision was announced last week, following a review by the holding company, Jossi Holding AG.

The news from Islikon-based Jossi coincided with the annual conference of MedTech Europe, the MedTech Forum (MTF, May 15-16), in Paris, where several companies were again warning of the damage...

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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

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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.