Medical Devices Act: Important Information & Regulations

The Medical Devices Act (MPG) is crucial for medical technology in Germany. It regulates how medical devices are handled and sets standards for healthcare.

The main goal of the Act is to ensure the safety of medical devices. It protects patients and others from risks. All products that do not act through medication fall under these regulations.

The MPG provides clear rules for manufacturers and users. It ensures that only safe products are used, thus helping to improve medical care in Germany.

Definition and Purpose of the Medical Devices Act

The Medical Devices Act (MPG) is essential for regulating medical devices in Germany. It helps ensure patient safety while maintaining high product quality.

Scope of the Act

The MPG covers everything related to medical devices and their accessories. It addresses the marketing, operation, and use of these products. This includes software and devices that administer medication.

Safety and Protection

The primary goal of the Act is to protect patients, users, and others. It sets high standards for the manufacturing and use of medical devices to maximize safety.

Distinction from Other Laws

The MPG differs from other laws. It does not apply to pharmaceuticals, cosmetics, or blood products, which are regulated by other laws such as the Medicinal Products Act or the Chemicals Act.

The clear definition and scope of the MPG provide a legal framework ensuring the quality and safety of medical devices.

Fundamental Requirements for Medical Devices

Medical devices must adhere to strict rules to ensure patient safety. The CE marking is very important as it indicates that a product meets EU safety standards. All medical devices sold in the EU must have this marking.

CE Marking and Conformity Assessment

The CE marking indicates that a product is safe. Before receiving this marking, a product undergoes a safety assessment. This assessment, known as conformity assessment, checks if the product meets all necessary criteria.

The extent of the assessment depends on the risk class of the product. Products with lower risks are tested less frequently.

Classification of Medical Devices

Medical devices are classified into four risk classes. Low-risk products, such as bandages, fall into Class I. High-risk products, like pacemakers, are in Class III. The higher the class, the more stringent the testing requirements.

Custom-Made and In-House Products

Custom-made products have specific rules. They must meet basic requirements but do not need CE marking. In-house manufactured products in hospitals follow similar rules but must still adhere to high safety standards.

Medical Devices Act: Key Regulations for Manufacturers and Operators

The Medical Devices Act (MPG) sets clear rules for manufacturers and operators. Manufacturers must establish and maintain a quality management system. This helps ensure product quality and safety.

Operators are responsible for the proper maintenance and servicing of devices. They must conduct regular maintenance and train staff to ensure safe use of medical devices.

Special rules apply to implants. Manufacturers must provide essential information and implant passports containing important data about the product and follow-up care.

The Medical Devices Operator Regulation complements the MPG by providing details on the operation and use of medical devices. Operators must adhere to these rules to ensure patient safety.

• Manufacturers: Establish a quality management system.
• Operators: Ensure maintenance and training.
• Implants: Comply with specific information obligations.

Adhering to these rules is crucial for the safety of medical devices. They protect patients, users, and others from risks.

Clinical Evaluation and Testing of Medical Devices

Evaluating medical devices is crucial to ensure their safety and effectiveness. Clinical trials are a key part of this process and must follow strict regulations.

Requirements for Clinical Trials

Before a clinical trial begins, extensive preparation is required. The trial protocol must be detailed, describing the study's objectives, methods, and risks.

Qualified physicians and appropriate facilities are also necessary.

Approval Procedures and Ethics Committees

Before starting, a clinical trial must be approved. An ethics committee must also review and approve the study, ensuring that participants are well protected.

Conduct and Reporting Obligations

The trial must adhere to the latest scientific standards. Physicians must report the start, end, and any premature termination of the trial. Special rules apply to in-vitro diagnostics.

Strict regulations ensure participant safety and data quality. This ensures that new medical devices can be safely evaluated and approved.

Monitoring and Safety of Medical Devices

The safety of medical devices is crucial. The medical device vigilance system helps identify risks. Manufacturers and operators must report defects and recalls.

Effective risk management is also essential. Manufacturers are required to have a safety officer for medical devices. This person collects and evaluates information about risks and decides on necessary actions.

Authorities regularly inspect medical devices and can implement measures such as recalls or sales bans. The goal is to protect the safety of patients and others.

• Reporting obligations for incidents and recalls
• Risk identification and assessment
• Appointment of a safety officer
• Regular regulatory inspections

Collaboration between manufacturers, operators, and authorities is vital for the effective functioning of the medical device vigilance system. It helps continuously improve the safety of medical devices.

Economic Importance and Innovation Promotion

The medical technology sector is vital to the German economy. Germany ranks third in medical device exports and holds a 9.3 percent share of global trade. Approximately 210,000 people work in this sector, primarily in medium-sized enterprises.

To strengthen innovation, the Medical Technology Strategy Process was introduced. This process helps enhance competitiveness and promote new technologies.

Various measures support innovation:

• Establishment of an innovation fund
• Promotion of medical data registries
• Support for the development of new products
• Improvement of collaboration between research and industry

The Medical Technology Strategy Process helps Germany maintain its international strength. By promoting and supporting innovative ideas, Germany aims to strengthen its economic position.

Future Developments and Challenges

The medical device sector faces significant changes. Digitalization in healthcare brings new opportunities and risks. The Medical Device Implementation Act (MPDG) imposes stricter rules for the safety and performance of medical devices.

eHealth and telemedicine are becoming increasingly important. The development of a telematics infrastructure aims to advance digital networking in healthcare. Manufacturers must adapt their products to these new technological capabilities.

The industry must adjust to new regulations and technological advancements, requiring investments in research and development. Only by doing so can companies remain competitive and leverage the opportunities presented by digitalization in healthcare.

FAQ about the Medical Devices Act

What is the Medical Devices Act (MPG)?

The Medical Devices Act (MPG) regulates the handling of medical devices in Germany. It ensures the safety and suitability of these products, protecting patients, users, and others.

What products are covered by the Medical Devices Act?

The MPG covers products such as instruments and software used for medical purposes. Their primary effect is not achieved through medication.

What is the CE marking and why is it important?

The CE marking indicates that a medical device meets the requirements of the MPG. It is a prerequisite for placing the product on the market.

What obligations do manufacturers of medical devices have?

Manufacturers must establish a quality management system and conduct a conformity assessment. A safety officer is also required. Manufacturers are responsible for monitoring and reporting incidents.

Under what conditions are clinical trials permitted?

Clinical trials require approval and a positive ethics committee review. They must be conducted according to the latest scientific knowledge.

How is the monitoring of medical devices regulated?

The MPG provides for a monitoring system where manufacturers and operators must report incidents. Authorities conduct regular inspections.

What is the economic importance of the medical technology sector?

The medical technology sector is economically significant for Germany, which ranks third in exports and employs around 210,000 people.

What challenges does digitalization pose for medical devices?

Digitalization presents challenges such as stricter safety and performance requirements under the MPDG. A telematics infrastructure aims to promote eHealth and telemedicine.