What is the optimal approach for integrating fluid and pneumatic components and systems into medical equipment, so that products can meet the strict requirements of the (EU) 2017/745 regulation, Medical Device Regulation (MDR)?
Medical devices are products with a medical purpose that the manufacturer intends to be used on humans. This includes instruments, apparatus, machines, implants, reagents for in vitro use, materials, and related items used either alone or in combination.
A whitepaper, How the Medical Device Regulation impacts the fluid and pneumatic systems used in medical technology, highlights some optimal approaches.
The MDR requires:
- More stringent risk assessment of existing medical devices
- Medical devices that are classified as high risk must demonstrate safety and performance profiles in clinical trials
- A unique product key for all medical devices
- More stringent regulatory monitoring
- New certificates without exceptions
The MDR imposes higher demands on medical device manufacturers. With regard to quality assurance, the internationally recognized quality management system (QMS) standard EN ISO 13485:2016 for medical devices is becoming more important and is audited by independent bodies. Another aspect is technical documentation. Detailed description, specification, verification, and validation of a medical device must be recorded, but the need to continuously update data and information, as well as the extended retention period of 5 to 10 years, pose challenges.
What is the role of valve technology?
Because the purity of liquids used in medical applications is essential, the manufacturing processes and facilities used to produce fluid control products are critical. For fluid and pneumatic components in particular, any possible contamination of liquids and other media should be minimized, and this can be achieved thanks to modern cleanroom production.
Valves are a core technology in medical devices. These are used extensively in surgical devices, dental treatment units, and ventilators. Not only does the MDR make it more challenging to comply with regulations and approval requirements in product development, but expectations of the valves are also increasing.
Download the whitepaper and visit the Automation in Medical Manufacturing section on Emerson.com to learn more about solutions for rapid delivery and safe, reliable, and compliant performance of medical products and equipment.
