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Germany’s Ethical Supply Chain Rules In Force

 
• By Ashley Yeo

New supply chain due diligence rules came into force this month in Germany, ensuring that every commercial business over a certain size respects social and environmental criteria. The medtech industry is receiving practical compliance advice.

Wooden cubes with checkmark icon.
• Source: Shutterstock

Germany’s new supply chain due diligence law (LkSG, or Lieferkettengesetz in its short form) came into force on 1 January for companies with more than 3,000 employees. This group numbers some 600 companies, according to the federal ministry for labour and social affairs, BMAS. A further 3,000 firms – those employing over 1,000 staff – will be subject to enforcement in January 2024.

Small and medium-sized enterprises (SMEs) manufacturing or distributing medtech will be affected indirectly, insomuch as they trade with companies –...

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More from Germany

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

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.

More from Europe

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.