The medtech sector in Germany plays a central role in the healthcare industry and is a key driver of innovation and technological progress. With a turnover of approx. 40 billion euros (including micro-enterprises approx. 55 billion euros) in 2023, an export rate of around 68% and over 265,000 employees, this sector is an important pillar of the German economy. In recent years in particular, companies have made great progress in the development of individualised and data-driven medical products.

The increasing bureaucratic requirements, mainly in the area of sustainability, such as the German Supply Chain Duty of Care Act (LkSG) and the strict provisions of the EU Medical Device Regulation (MDR), are currently presenting many companies with complex tasks. These regulatory requirements increase complexity and costs and significantly impair the industry's innovative strength. Innovation bottlenecks and the relocation of research projects abroad are often the result. Smaller manufacturers in particular are suffering from these effects and are also planning to relocate their activities abroad.

Another pressing issue is the current debate surrounding perfluorinated and polyfluorinated alkyl substances (PFAS). PFAS are an indispensable component of many vital medical products due to their longevity and resistance in the human body. A blanket ban, as is currently being discussed under the European REACH regulation on the registration, evaluation, authorisation and restriction of chemicals, could have a serious impact on the security of supply. The German Medical Technology Association (BVMed) emphasises that differentiated and practical regulation is essential in order to avoid supply bottlenecks and simultaneously fulfil sustainability goals.

Despite these challenges, the medical technology sector offers enormous opportunities. With over 30 specialised medical technology clusters, Germany is a leading location for innovation. These networks promote cooperation between companies, universities and research institutions and create the basis for pioneering developments that are recognised worldwide under the "Made in Germany" seal of quality.

Advances in medical technology, such as new diagnostic and treatment methods, are also making a significant contribution to market dynamics. Innovations in artificial intelligence, robotics and personalised medicine are creating new opportunities and applications that are further increasing the demand for modern medical technology products.

Our experts offer medical technology companies support in navigating the challenging German pharmaceutical and healthcare markets. Thanks to our many years of experience in both sectors and our close collaboration with pharmaceutical companies, doctors and clinical specialists, we understand the specific requirements of both markets. These insights help us to develop customised strategies for medtech companies that take into account both the needs of end users and regulatory requirements in the best possible way.

Our comprehensive market analyses facilitate entry into the German market and help to overcome regulatory hurdles.