What is an In Vitro Diagnostic Device?
In Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples, (e.g., blood, urine and tissue that has been taken from the human body) in order to:
- Help detect infection
- Diagnose a medical condition
- Prevent disease
- Monitor drug therapies
Devices can range from simple tests to sophisticated DNA technology including reagents, calibrators, control materials, kits, software, and related instruments.
IVD is an important segment in the global healthcare industry. The marketplace is witnessing rapid growth fuelled by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests. IVDs add significant value to treatment processes and medical diagnoses, enhancing the well-being of the general public.
The In Vitro Diagnostics Directive (IVDD) 98/79/EC is a set of regulatory requirements that medical device manufacturers must comply with in order to place a CE Mark to their product. The aim of the IVDD is to protect the health and safety of patients and users – and serve the best interests of third parties – to ensure that manufacturers meet quality standards and demonstrate their products are safe, effective, and perform as intended.