IVD Regulatory Services

In Vitro Diagnostics (IVD) constitutes an essential and valuable segment in the global healthcare industry. The market place is witnessing rapid growth fueled by continued technological advancements, better diagnostic tools, improved treatment monitoring, faster response times and increased availability of over-the-counter tests.  IVDs are fast becoming an indispensable part of worldwide healthcare systems while adding value to patients and medical professionals along with enhancing the well-being of the general public.

What is an In Vitro Diagnostic Device?

IVDs are medical devices and accessories used to perform tests on samples, such as blood, urine, tissue, taken away from the human body to help detect infection, diagnose a medical condition, prevent disease or monitor drug therapies. There are several key IVD disciplines including clinical chemistry, molecular diagnostics, immunochemistry, haemostasis, haematology and microbiology. Devices can range from simple tests to sophisticated DNA technology including reagents, calibrators, control materials, kits, software and related instruments.

CE Marking and the In Vitro Diagnostic Directive (IVDD)

The In Vitro Diagnostics Directive (IVDD) 98/79/EC (link below to website) is a set of regulatory requirements that medical device manufacturers must comply with in order to affix a CE marking to their product. The CE marking allows the company to gain access to the 30 member states that comprise the European Economic Area (EEA) which was formed as a single market to promote free trade.

Directive 98/79/EC of the European Parliament and of the Council

The aim of the Directive is to safeguard the health and safety of patients, users and third parties ensuring that the manufacturer meets quality standards and demonstrates their products are effective and perform as intended. The IVD manufacturer is responsible for complying with the Directive; however, the use of a Notified Body may be required.  Higher risk devices require a Notified Body to assess compliance before placing the device on the European market.

BBL IVD Quality Management Service

BBL has a dedicated in- house IVD team which has both industry and regulatory experience that enables a true understanding of your needs and challenges. We provide open communication, speed-to-market programs and balance independence with partnership to ensure reviews stand up to scrutiny while at the same time working together to meet your corporate goals.