Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG
Medical Technology · Tuttlingen
Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG is a medical technology company based in Tuttlingen, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG Address & Contact
Hermle Mechanical Movements and Turned Parts GmbH & Co. KG at a Glance
Hermle Mechanical Movements and Turned Parts GmbH & Co. KG from Tuttlingen in Baden-Württemberg is a traditional manufacturer of precision turned parts and mechanical components, which also supplies the medical technology industry. The company produces precision components made of metal and plastics for demanding applications. Tuttlingen, as a medical technology center, provides excellent conditions for suppliers in the industry. With over 150 years of experience in watch and precision technology, Hermle has established itself as a trusted partner in product development and manufacturing.
Services and Products
Hermle manufactures highly precise turned parts, milled parts, and mechanical components for medical technology and other industries such as automotive and watchmaking. The product range includes, for example:
- Precision turned parts: Made from various materials such as stainless steel, aluminum, and plastics, suitable for highly complex medical devices.
- Milled parts: Highly accurate components designed for specific applications in medical technology, such as for surgical instruments or diagnostic technologies.
- Assembly services: Assembly of complete assemblies, which increases efficiency in production and saves time and costs for medical technology manufacturers.
The precision manufacturing is carried out according to strict quality standards using modern CNC technology. Medical technology components are produced according to ISO 13485-compliant processes, ensuring adherence to the highest international quality and safety standards. Hermle is also certified according to other standards such as ISO 9001, which underscores the quality and efficiency of the company's processes.
Regulatory Classification
The products of Hermle fall within the regulated area of medical technology, requiring careful compliance with all relevant laws and guidelines. Adhering to Directive 93/42/EEC on medical devices is of central importance to the company. This includes not only product certification but also continuous quality monitoring and risk management to meet the high demands of manufacturers and end consumers. Furthermore, Hermle is committed to research and development to provide innovative solutions that meet the latest technical standards.
Location Tuttlingen / Baden-Württemberg
Tuttlingen is the world's leading location for medical technology manufacturing and surgical instruments. As a supplier in this cluster, Hermle benefits from unique proximity to its customers and the industry-specific quality networks on site. The city is home to numerous highly specialized companies with which Hermle maintains close cooperation. These synergies allow quick responses to market demands and the development of innovative products that meet the needs of the medical technology industry.
However, the regional significance of Tuttlingen extends not only to large companies but also to numerous start-ups and innovation centers that accompany projects from the idea to product maturity. This creates a dynamic environment for the exchange of know-how and fosters competitiveness.
Special Features of Hermle
One of Hermle's special strengths lies in the combination of decades of experience and state-of-the-art manufacturing technology. The company focuses on the continuous training of its employees and invests in the latest machines and technologies to ensure the highest precision and efficiency. Additionally, Hermle places a strong emphasis on sustainability by implementing energy-efficient production methods and selecting innovative materials to minimize the ecological footprint.
The close cooperation with customers from the medical technology sector enables Hermle to create tailored solutions specifically adapted to the challenges and needs of the respective application. Notably, fast prototyping allows customers to bring products to market more quickly.
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Frequently asked questions about Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG
What does Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG do?
Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG is a company in the medical technology sector based in Tuttlingen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG located?
Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG is headquartered in Tuttlingen. More information can be found on the company's website.
In which area of medical technology is Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG active?
Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG is active in the medical technology sector and offers solutions for medical facilities, clinics and practices. You can find the exact areas of focus on the company's website.
Hermle Mechanische Uhrwerke und Drehteile GmbH & Co. KG on social media
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About Medical Technology
Germany's medical technology sector is one of the most important in the world. With annual revenues of approximately EUR 36 billion and more than 1,400 companies, Germany ranks as the third-largest medical technology market globally (SPECTARIS 2023), after the United States and Japan. The sector encompasses the development, manufacture and distribution of an extraordinarily wide range of products: in-vitro diagnostic (IVD) devices, medical imaging systems (CT, MRI, ultrasound), implants such as hip and knee prostheses, cardiac pacemakers, surgical instruments, hospital beds, wound care products and medical software classified as a Software as a Medical Device (SaMD). In Germany and across the European Union, medical devices must comply with the EU Medical Device Regulation (MDR 2017/745), which replaced the former Medical Devices Directive (MDD 93/42/EEC). Devices are classified into risk classes I, IIa, IIb and III. Higher-risk classes require a conformity assessment by a designated Notified Body (benannte Stelle) before a CE mark can be affixed. The CE mark signals that the product meets EU safety, performance and quality requirements and may be placed on the European market. Key medtech clusters in Germany include the Munich and Nuremberg region in Bavaria, the Rhine-Main area in Hesse, Tuttlingen in Baden-Württemberg (known as the world capital of surgical instruments) and the Hamburg metropolitan area. This directory lists CE-certified manufacturers, distributors and suppliers across the German medtech sector with full contact details.
Germany as a Global Medical Technology Hub
Germany's position as the world's third-largest medical technology market is underpinned by a combination of industrial engineering excellence, a well-funded healthcare system and a highly productive research landscape. The German medtech sector is characterised by a large number of small and medium-sized enterprises (SMEs) that are often hidden champions (Weltmarktführer) in specialised niches. Unlike the pharmaceutical sector, where large corporations dominate, the medtech industry is more fragmented and innovative, with frequent spin-offs from university hospitals and engineering faculties. Key product categories include imaging systems (MRI, CT, X-ray, ultrasound), endoscopy and minimally invasive surgical tools, orthopaedic implants, cardiovascular devices, in-vitro diagnostics, dental equipment, ophthalmic devices, wound care systems and hospital IT and medical software. Germany is particularly renowned for its surgical instrument manufacturing, centred in Tuttlingen, Baden-Württemberg, which supplies operating theatres worldwide. The annual Medica trade fair in Düsseldorf is the world's largest medical technology exhibition and serves as a global industry showcase.
EU MDR Compliance and CE Marking for German Manufacturers
The EU Medical Device Regulation (MDR 2017/745) replaced the former Medical Devices Directive (MDD 93/42/EEC) and has applied in full since May 2021, with transition periods for legacy devices extended to 2028 in some cases. For German manufacturers selling in the EU market, MDR compliance is a legal necessity. The regulation introduced significantly strengthened requirements compared to the old MDD: more rigorous clinical evidence requirements, mandatory post-market clinical follow-up (PMCF), unique device identification (UDI) registration in the EUDAMED database, increased obligations for Notified Bodies, and stricter rules for software as a medical device (SaMD). The risk classification system under MDR uses four classes (I, IIa, IIb, III) based on the intended purpose, duration of use and body contact of the device. Manufacturers must appoint an authorised representative in the EU if they are not themselves based in an EU member state, and they must maintain a quality management system. In Germany, the Bundesnetzagentur and state authorities support MDR enforcement alongside BfArM.
Innovation and Research in German Medtech
Germany's medtech innovation ecosystem benefits from close collaboration between industry, university hospitals (Universitätsklinika), applied research institutes (such as those of the Fraunhofer and Helmholtz networks) and health technology assessment bodies. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) play important roles in assessing which new medical technologies are eligible for reimbursement by statutory health insurance (GKV). This reimbursement pathway, known as the NUB process (Neue Untersuchungs- und Behandlungsmethoden) for hospital technologies, is a key milestone for commercial success in Germany. Innovative devices that receive a positive NUB assessment can be reimbursed at negotiated rates by statutory insurers, providing a significant market access advantage.
Innovation Fields and Future Technologies
The German medical technology sector is driving numerous future fields forward. AI-supported diagnostics and image analysis are revolutionising radiology and pathology; algorithms for the early detection of cancer and cardiovascular disease are increasingly receiving CE approvals as Software as a Medical Device (SaMD). Robot-assisted surgical systems, led by products from Siemens Healthineers, Brainlab and Karl Storz, are improving precision in complex procedures. Minimally invasive technologies, implantable pacemakers and intelligent prostheses with sensory feedback demonstrate the breadth of innovation. Point-of-care diagnostics enables rapid tests directly in the doctor's surgery or at the bedside. Telemedicine and digital patient records promote networking between medical devices and clinical workflows. The Federal Ministry of Education and Research (BMBF) funding programme specifically supports the development of innovative medical technology products through cooperation between industry and universities.
What does the medical technology sector cover?
Medical technology encompasses the development, manufacture and distribution of medical devices, instruments, software and accessories used to diagnose, prevent, monitor or treat diseases. Germany ranks among the world's leading medical technology hubs.
How are medical devices approved in Germany?
Medical devices in Germany and the EU must comply with the EU Medical Device Regulation (MDR 2017/745) and carry the CE mark. Depending on the risk class, conformity assessments by notified bodies are required.
Where can I find medical technology companies in Germany?
Medical technology companies in Germany can be found through industry associations such as SPECTARIS, BVMed or ZVEI, and via the EUDAMED EU database for registered manufacturers. Sanoliste provides a searchable directory of manufacturers, distributors and suppliers across the German medical technology sector.
How many medical technology companies are there in Germany?
Germany has more than 1,400 medical technology companies generating annual revenues of approximately EUR 36 billion (SPECTARIS 2023), making it the third-largest medical technology market in the world. The majority of companies are small and medium-sized enterprises (SMEs), many of which are world market leaders in their niche.
What are the risk classes for medical devices under the EU MDR?
The EU Medical Device Regulation (MDR 2017/745) classifies medical devices into four risk classes: Class I (lowest risk, e.g. bandages, glasses frames), Class IIa (medium risk, e.g. hearing aids, contact lenses), Class IIb (higher medium risk, e.g. infusion pumps, ventilators) and Class III (highest risk, e.g. implantable cardiac devices, neurosurgical instruments). Higher classes require more rigorous conformity assessment by a Notified Body.
Where are the main medical technology clusters in Germany?
Germany's medical technology industry is concentrated in several regional clusters. Bavaria (particularly Munich and Nuremberg) and Baden-Württemberg (notably Tuttlingen, globally known for surgical instruments) are the two strongest regions. Other significant clusters include the Rhine-Main area in Hesse, the Hamburg metropolitan region, the Ruhr area in North Rhine-Westphalia and the Berlin-Brandenburg region.
What is a Notified Body (benannte Stelle) and why does it matter?
A Notified Body (benannte Stelle) is an independent third-party organisation designated by an EU member state to assess whether medical devices meet the requirements of the MDR before they can carry the CE mark. For Class IIa, IIb and III devices, manufacturers must have their quality management system and technical documentation assessed by a Notified Body. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) oversees market surveillance, while several German organisations hold Notified Body status under the MDR.