How the Medical Device Regulation impacts the fluid and pneumatic systems used in medical technology
The manufacture of medical devices and equipment is subject to a large number of standards and regulations, including the European Parliament’s (EU) 2017/745 regulation, known as the Medical Device Regulation (MDR).
The MDR stipulates the reclassification of several medical devices and requires more stringent risk assessments. This increases the requirements demanded of medical device manufacturers, who are already faced with rising costs in terms of documentation, quality assurance, and quality management.
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