The Medical Device Regulation (MDR), in force since May 26, 2020, replaces the previous Medical Devices Act (MPG) and places stricter requirements on the safety and performance of medical devices. This regulation affects not only manufacturers, but also importers, distributors and medical facilities.
Definition of the Medical Device Regulation (MDR)
The Medical Device Regulation M DR regulates the trade in medical devices in the EU and defines the requirements for their use in the medical field. This includes fitness equipment used for therapeutic purposes.
Importance of MDR certification for manufacturers and users
For manufacturers, compliance with the MDR means that they must appoint a designated person for compliance and provide comprehensive technical documentation and clinical evaluations. Users, such as hospitals and physiotherapy practices, benefit from higher device safety and performance standards.
Overview of the criteria and requirements
The MDR requires that all medical devices, including appropriate fitness equipment, carry an identification number and are regularly tested to ensure their safety and performance throughout their lifetime. This includes the need for devices to be medically and technically safe and of the required quality for health protection.
Important aspects of MDR certification for fitness equipment
Safety standards and performance testing
MDR certification ensures that fitness equipment for therapeutic applications, for example, is subject to strict safety standards and performance tests in accordance with EN 62353. These tests identify potential defects, reduce the risk of accidents and increase safety for users and staff. Equipment that passes these tests receives a test sticker indicating the next test date.
Risk management and quality control
Manufacturers must carry out comprehensive risk management in accordance with ISO 14971 to ensure the safety and effectiveness of the devices. This includes the early identification of risks and the implementation of control measures to minimize them.
Clinical evaluation and review process
The MDR requires that all medical devices, including fitness equipment, undergo a clinical evaluation to verify their safety and performance. These assessments are based on clinical data and must be updated regularly to ensure compliance with the latest medical standards.
Impact and benefits of MDR certification
The introduction of MDR certification has a significant impact on the quality and safety of medical devices. Stricter regulations and comprehensive clinical evaluation will ensure that every product meets the highest safety standards. This not only promotes consumer confidence, but also strengthens the position of manufacturers in the European market. With MDR certification, manufacturers can easily distribute their products throughout the EU, giving them a significant competitive advantage. By complying with these strict regulations, companies demonstrate their commitment to ensuring patient safety and complying with legal requirements, which helps to boost public confidence.
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Editorial team fitnessmarkt.de
Image source: Brother International GmbH
Published on: 12 June 2024