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Germany’s Digital Health Fast-Track Scheme: What Manufacturers Need To Know

 
• By Eliza Slawther

Understanding the German reimbursement system is crucial for any medtech firm eyeing the European market, and healthtech innovators in particular may benefit from its fast-track digital health app scheme. But how does the scheme work, and who can apply?

Germany Digital
• Source: Shutterstock

The value of digital healthtech is being increasingly recognized by payers and health technology assessment (HTA) bodies in Europe. A multinational EU working group is currently developing recommendations on how best to assess digital medical devices, while the UK’s regulator recently received a funding boost for use in creating a regulatory framework for mental health apps.

Germany has been ahead of the trend for some time, which is not surprising given it has the largest medtech market in Europe by some margin. Its Federal Institute...

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