22 Examples of surgical instruments (source Fotolia/Adobe Stock) of manufacturers, suppliers, and trades businesses, as well as specialized mechanical engineering companies and tool makers. Among them are large companies such as Aesculap (part of the B. Braun Group) with over 3,700 employees at the Tuttlingen site and billions in annual revenue. Karl Storz SE & Co KG – which has a workforce of just under 10,000 – is another big player in the manufacture of endoscopes and minimally invasive systems. Accompanying them are numerous small to medium-sized and specialized manufacturers that frequently operate within one particular segment, have flexible production processes, and blend quality with mastery of their trade. The region benefits from what is known as the “cluster effect”: Expertise, production technologies, supply chains for metalworking, grinding, polishing, and heat treatment etc. have a strong presence in the region. This enables fast response times, along with outstanding quality and innovations based on excellent craftsmanship and technology. 3. Challenges facing the sector 3.1 Regulatory requirements The regulatory framework, in particular the EU Medical Device Regulation (MDR), is among the key issues. It introduced stricter requirements for technical documentation, clinical evaluation, post-market surveillance, traceability (e.g. UDI), and risk management, among other things. This often brings significant hikes in expenditure and costs for small and medium-sized manufacturers. Delays in certification by notified bodies can also present difficulties. ENGLISH
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