PAUL HARTMANN AG
Medical Technology · Heidenheim
PAUL HARTMANN AG is a medical technology company based in Heidenheim, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Company profile
1818
Founded
11.000+
Employees
Paul Hartmann AG Overview
Paul Hartmann AG is one of the oldest German companies in the medical and healthcare sector and has its headquarters in Heidenheim an der Brenz (Baden-Württemberg). The company was founded in 1818 by Ludwig Hartmann in Heidenheim and initially produced cotton yarns and fabrics. Over the decades, Hartmann developed into one of the leading manufacturers of medical consumables, wound care products, and incontinence items. Today, the Hartmann Group employs around 11,000 people worldwide and is represented in more than 35 countries. The company is listed on the Frankfurt Stock Exchange (regulated market). Heidenheim remains the heart of the company, with extensive production and administration facilities.
Field of Activity & Products
Hartmann operates in four strategic areas: wound management, incontinence management, infection management, and sterile supply. In wound management, the product range includes dressings, wound pads (e.g., hydrocolloid and foam dressings), wound rinsing solutions, and fixation materials. In the field of incontinence management, the MoliCare brand is one of the best-known products for those affected and care facilities across Europe. Hartmann offers both light and highly absorbent products specifically tailored to the needs of people in various life situations.
In the field of infection prevention, Hartmann produces disinfectants (under the renowned Bode brand), gloves, protective gowns, and other hygiene products used in hospitals, medical practices, and laboratories. Special attention is paid to the stringent requirements for the medical sector. Furthermore, Hartmann develops innovative sterile covering systems and surgical items that find application in modern surgery. The suture systems are the result of years of research and development, enhancing quality and reliability.
Regulatory Standards & Quality Assurance
Hartmann's products are subject to the stringent requirements of the EU Medical Device Regulation (EU-MDR), the EU IVD Regulation, as well as the provisions of the German Medicines Act (AMG). The company adheres to comprehensive quality management systems according to ISO 13485 and also maintains numerous approvals in the markets where it operates. Additionally, Hartmann continuously invests in research and development to ensure that the products reflect the latest scientific findings and meet the highest safety standards.
History & Market Position
Hartmann is an early pioneer of the German medical technology industry and looks back on over 200 years of company history. The company early on adapted industrial manufacturing processes for medical textiles and established itself as a reliable supplier for hospitals and pharmacies. With innovative products and a sustainable corporate strategy, Hartmann has solidified its market position. Moreover, the company is a member of the Federal Association of Medical Technology (BVMed), which acts as the voice of the industry and advocates for the interests of medical technology companies.
The regional significance of Paul Hartmann AG in Baden-Württemberg should not be underestimated. As one of the major employers in Heidenheim, the company plays a key role in the regional economy and contributes to securing skilled labor. Through close cooperation with local educational institutions, Hartmann also promotes the development of skilled personnel in the field of medical technology.
Particularly noteworthy is Hartmann's sustainability strategy, which is reflected in the development of environmentally friendly products and production processes. Continuous efforts are made to reduce the ecological footprint, which is central to the increasingly important issues of climate protection and resource conservation.
Further information: Medical Technology in Baden-Württemberg or all medical technology companies in Germany on Sanoliste.
Frequently asked questions about PAUL HARTMANN AG
What does PAUL HARTMANN AG do?
PAUL HARTMANN AG is a company in the medical technology sector based in Heidenheim. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is PAUL HARTMANN AG located?
PAUL HARTMANN AG is headquartered in Heidenheim. More information can be found on the company's website.
In which area of medical technology is PAUL HARTMANN AG active?
PAUL HARTMANN AG 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.
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Medical Technology in Germany
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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.