Summira GmbH
Medical Technology · Rhein-Sieg-Kreis
Summira GmbH is a medical technology company based in Rhein-Sieg-Kreis, Germany. The company operates in the German medical devices market under the EU Medical Device Regulation (MDR 2017/745).
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Summira GmbH Address & Contact
Summira GmbH Overview
Summira GmbH from the Rhein-Sieg-Kreis in North Rhine-Westphalia is a key player in the field of digital health solutions and medical technology software. Founded with the aim of improving efficiency in healthcare, the company develops innovative IT solutions specifically tailored to the needs of hospitals, medical practices, and care facilities. These solutions are not only technically advanced but also user-friendly, promoting their acceptance among medical staff and thus directly contributing to the quality of patient care.
Services and Products
Summira offers a variety of software solutions that focus on different aspects of healthcare. These include:
- Patient Data Management: A cloud-based platform for securely managing patient data, which complies with data protection regulations while facilitating access to information for the authorized training of medical staff.
- Digital Documentation: Support for electronic patient records and automated documentation processes that significantly reduce administrative workload.
- Clinical Workflow Management: Optimization of processes within medical facilities through tailored digitized workflows.
- Mobile Access: Applications for mobile devices that ensure location-independent data availability, thus facilitating flexible work.
These product types meet the requirements of the latest regulatory frameworks, and the company is committed to always meeting current standards and legislative requirements.
Regulatory Classification
As a provider of medical technology, Summira GmbH is subject to strict regulatory requirements. The products must not only meet the standards of the Medical Device Regulation (MDR) in the European Union but also comply with the provisions of the Digital Healthcare Act (DVG). These regulations ensure that the software solutions are both safe and effective and assist in improving patient care. Summira is intensively working on certifying its products to remain competitive in the market for digital health solutions and to comply with the highest standards.
Location Rhein-Sieg-Kreis / North Rhine-Westphalia
The Rhein-Sieg-Kreis in the Cologne/Bonn metropolitan area is a significant location for IT and healthcare companies. The region benefits from excellent connections to research institutions such as the University of Bonn and the Bonn-Rhein-Sieg University of Applied Sciences. These institutions are not only training grounds for future professionals but also partners in research projects that advance innovative approaches in digital medicine.
Summira GmbH plays an important role in this ecosystem by actively participating in networks and initiatives that promote knowledge exchange between research, industry, and medical practice. Collaborating with local educational institutions allows the company to quickly adapt the latest technologies and trends and to develop products that meet the actual needs of medical facilities.
Characteristics of Summira GmbH
A standout feature of Summira GmbH is its commitment to user-friendliness and integration into existing systems. This is ensured through close collaboration with end users to make sure that the software solutions are intuitive and seamlessly fit into the workflows of healthcare providers. Furthermore, the company emphasizes ongoing training and education for staff to optimize the use of the software solutions and ensure that all employees are familiar with the latest developments.
To foster innovation and responsiveness to market changes, Summira has also established strategic partnerships with other technology providers and start-ups in the field of health IT. This enables the company to rapidly expand its product range and offer versatile solutions tailored to customers' individual needs.
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Frequently asked questions about Summira GmbH
What does Summira GmbH do?
Summira GmbH is a company in the medical technology sector based in Rhein-Sieg-Kreis. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.
Where is Summira GmbH located?
Summira GmbH is headquartered in Rhein-Sieg-Kreis. More information can be found on the company's website.
In which area of medical technology is Summira GmbH active?
Summira GmbH 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.
More Medical Technology in Rhein-Sieg-Kreis
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.