KARL STORZ Makes a Fresh Start in Neurosurgery in Europe

Endoscopic neurosurgery: a niche with great significance

Within its broad portfolio for various medical specialties, KARL STORZ is also involved in highly specialized niche areas of medicine. The focus is always on ethical responsibility towards patients. One example of this is endoscopic neurosurgery, which enables particular procedures through millimeter-sized openings—for example, in the treatment of hydrocephalus in newborns. In January 2020, however, KARL STORZ had to announce with a heavy heart that the supply of neurosurgery products in Europe would have to be discontinued due to the new MDR requirements and economic conditions. The threat of supply shortages for the medical sector and the associated risk to patients, as well as clear feedback from the market, were taken into account. As a result, steps were taken to re-certify the products for the CE market and thus contribute to the best possible care.

The intensive path to CE certification and back to the European market

Returning to the European market was and remains a major challenge, as the MDR requires complete recertification—even for established and proven products. This means that every product must be re-evaluated and approved in accordance with regulations, regardless of how long it has already been in successful use. Only after certification has been completed can the portfolio be offered in Europe again. Class III products in particular are subject to strict requirements. While some suppliers have withdrawn from this field, KARL STORZ has deliberately chosen the challenging path back into the market—in the interests of medical care and patient safety. The path to approval began in 2020 with the launch of a comprehensive MDR Class III program. Various product groups were gradually submitted by KARL STORZ for MDR recertification. The products underwent a complete development process, including extensive verification and validation— always with a focus on regulatory compliance and the highest quality standards. 

Milestone for the industry

The first successes came in July of this year: KARL STORZ's first Class III file was approved by TÜV SÜD. Final product availability is scheduled for the end of 2025. This result sends a strong signal to the market and confirms the company's regulatory expertise and quality commitment. "The successful approval of our first Class III file for neurosurgery is the result of years of intensive teamwork across departments,” said Christy Gaudet, Global Head of Solutions at KARL STORZ. “This success shows that regulatory excellence and innovative strength go hand in hand at our company—for the benefit of patient safety and clinical care. Because yes, we want to continue serving neurosurgery in CE markets as well, thereby improving the lives of patients—especially when it comes to treating the youngest among us." 

Reliable care—today and tomorrow

For medical facilities in Europe and other CE markets, this success means the timely and reliable return of proven KARL STORZ products. The first CE re-registrations have been completed— broader availability will follow from 2026. As part of the approval process, the portfolio was consolidated to ensure sustainable supply that is also economically viable. Quality and safety remain uncompromised—every step in the certification process is carefully reviewed. 

Communication is transparent and continuous, with regular information on availability, progress, and training opportunities. KARL STORZ products remain available without restriction in non-CE markets such as the US, Asia, and Latin America.

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