Medical devices serve a critical role in healthcare by improving patient outcomes. Due to the importance of their role, industry professionals must understand the external forces that can impact cleanroom operations and manufacturing, including regulations, regulatory authorities and standards bodies.
Elements that comprise a finalised medical device product, including development, manufacturing and global distribution, oftentimes operate on a global scale. However, it is important to note that many regulations are localised.
A fundamental understanding of the various localised regulations, regulatory authorities and standards bodies is important for industry professionals to successfully deliver patient technologies.
Regulatory authorities vs. standards bodies
While regulatory authorities and standards bodies are closely linked, they are not the same. Regulatory authorities are government agencies responsible for enforcing laws. They grant market authorisation, conduct inspections and take enforcement action.
Standards bodies operate by developing consensus-based standards. While not legally required, standards are commonly used by companies to demonstrate compliance with regulatory requirements.
Regulators often recognise or reference specific standards, and manufacturers rely on those standards to show that their processes, facilities and products meet regulatory expectations.
Regional regulatory authorities and standards
United States: In the United States, medical devices are regulated by the Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health. The FDA conducts premarket reviews and establishes registrations, device listings, inspections and post-market oversight.
The FDA’s Quality Management System Regulation (QMSR) sets the baseline requirements for manufacturers and cleanrooms. The regulation includes benchmarks for design controls, production, process validation, and corrective and preventive action.
Due to the nature of the high-level requirements, manufacturers frequently rely on voluntary standards.
The FDA maintains a list of recognised standards, including many developed by organisations such as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The FDA utilises a list of recognised ISO and IEC standards as an accepted method for companies to demonstrate conformity. Industry standards for cleanroom operations typically focus on sterilisation, contamination control and environmental monitoring.
European Union: In the European Union, medical devices are governed by
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Cleanroom Technology.
Subscribe now Already a subscriber? Sign in here.
