The Potential of In Vitro Medical Device Development

by | Jan 19, 2017 | 0 comments

The Potential of In Vitro Medical Device Development


In Vitro Diagnostic devices (IVD) are medical instruments, systems or accessories that are used to test samples taken from the human body—blood, urine, tissues samples or others—in order to determine a medical condition, detect, prevent or treat diseases, and monitor a patient’s state of health.


In Vitro medical device development is subject to rigorous testing in stages of component sourcing, manufacturing and inspection. In the United States, the Federal Drug Administration (FDA) classifies In Vitro Diagnostic devices into 3 classes, each class representing the degree to which the device in that category is subject to regulatory control that is necessary for quality assurance and distribution. This classification also determines what kind of processes the product must undergo before its entrance into the market.

Globally, In Vitro Diagnostic devices represent a huge and significant segment in the healthcare industry. As the population grows, so does the need for more technologically-advanced In Vitro Diagnostic systems used to diagnose and treat diseases. In keeping up with these demands, manufacturers have to be constantly aware of the strict regulations and international requirements imposed on In Vitro device development on global and domestic levels.

Specifically, the In Vitro Diagnostic Directive (IVDD) 98/79/EC represents a strict set of requirements that manufacturers must follow in order to ensure the top quality of In Vitro device development, and that end-users are receiving medical tools and devices that are reliable and safe to use. Manufacturers of In Vitro Diagnostic devices must follow the guidelines within the IVDD in order to acquire the CE mark for their products.

How does this process come about? Many medical consulting firms like EAP MedTech Consulting Sdn Bhd, Malaysia, exist to assist clients in sourcing and contract manufacturing in vitro diagnostic devices (or components they are made of) in line with international certification like the CE mark and ISO 13485/QSR to ensure their regulatory compliance at all stages, and swift entry into the global marketplace.

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