The path to MDR-compliant medical technology

Regulatory requirements in the medical technology sector are constantly rising. The European Medical Device Regulation (MDR) and standards such as DIN EN ISO 10993, 15001, and 18562 increase the effort involved in the development, documentation, and approval of new devices. With the Pure Flow pressure regulator 48.3, Kendrion offers a solution specifically designed for medical applications, helping manufacturers accelerate qualification processes and shorten development times.

For medical device manufacturers, regulatory assessment does not begin only with the finished product. Materials, manufacturing conditions, and technical documentation must meet application requirements as early as the component selection stage. This is where Kendrion’s Pure Flow pressure regulator 48.3 comes in; designed for the precise control of medical gases, it is used in ventilators, analytical instruments, anesthesia machines, and dental technology. Relevant standards were taken into account during development, and selected materials suitable for medical applications are used. In addition to medical gases, the pressure regulator can also be used for liquid applications, such as in dialysis systems. Manufacturing takes place under controlled conditions to meet the highest quality and cleanliness standards.

Kendrion makes pressure regulation MDR-ready

With the Pure Flow pressure regulator 48.3, Kendrion aims to support medical device manufacturers during the early stages of product development, the further development of existing products, and the replacement of existing pressure regulators. The regulator was developed to address increasing demands regarding safety, materials, and documentation, thereby reducing the effort required for qualification and integration.

"For many manufacturers in the medical technology sector, the regulatory challenge today begins not with the device itself, but with the selection of suitable components. With the Pure Flow pressure regulator 48.3, we help our customers address regulatory requirements at an early stage and reduce development risks," explains Sven Desens, Head of Fluid Technology at Kendrion. Precise Pressure Regulation for Sensitive Applications

In addition to meeting regulatory requirements, the Pure Flow pressure regulator 48.3 stands out due to its compact design. Measuring 30 x 30 x 46 mm and weighing approximately 40 g, it can be integrated into various device designs while saving space. The regulator reduces an inlet pressure of up to 10 bar to a constant, adjustable outlet pressure, thereby ensuring a stable supply of medical gases.

"Precise pressure regulation and high repeatability are crucial in sensitive application areas such as analytical technology and medical engineering. This is where the strengths of our diaphragm pressure regulators really come into play," says Florian Falk, Product Expert in Life Science & Medical at Kendrion.

Designed for low to medium flow rates, the pressure regulator offers precise control and high repeatability. By utilizing medical-grade materials, controlled manufacturing processes, and comprehensive technical documentation, it helps OEMs reduce development effort and product costs. The Pure Flow pressure regulator 48.3 is the first component of the Kendrion Pure Flow Line—a product series developed specifically to meet the demands of the medical technology sector. Kendrion’s goal is to provide reliable, regulatory-ready components for medical technology applications.