What is an In Vitro Diagnostic Device?

In Vitro Diagnostics (IVD) is an important segment in the global healthcare industry. The marketplace is witnessing rapid growth fueled 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.

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.

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 Marking 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.

Changes to the way In Vitro Diagnostics are regulated in Europe

View our resources below to learn more about the regulation changes to IVDs and how you can prepare by watching our latest webinar.

You can also watch our latest webinar on how to manage field safety notices.

IVD regulatory updates webinar Feb 2015
IVD field safety notices webinar Mar 2015
Regulation factsheet and web links
Regulation changes whitepaper 

Getting your IVD medical device to market

The BSI In Vitro CE marking and Quality Management Services are designed to assist you in getting your safe and effective device to global markets efficiently. Our dedicated in-house IVD team has both industry and regulatory experience, resulting in a comprehensive 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.

Why choose BSI for your product compliance to Directive (IVDD) 98/79/EC?

Whether your product is simple or complex, we are committed to delivering professional, robust, and responsive services in helping you obtain IVDD compliance.

Regulatory process and product expertise

• We have an outstanding team of in-house experts with an average of 17 years IVD industry and regulatory experience. These leading experts have worked on all aspects of the product life cycle including R&D, manufacturing and quality, and they understand the trends and frequent changes in the industry.

Easy access for customers

• With our streamlined structure, you will have a dedicated BSI specialist who understands your business, can answer your questions quickly, and will help optimize the process in getting your IVD device to European markets.

Batch testing

• BSI works with a world-leading test laboratory, Paul Ehrlich Institute in Germany to provide Annex II List A Verification of Manufactured Product testing. Companies using this laboratory that choose to transfer to BSI can keep their same testing facilities, enabling a seamless transition.

The degree of involvement of a Notified Body, an independent third party, is generally proportionate to the risks associated with your device. For example, higher risk devices require a Notified Body to assess compliance prior to the manufacturer making their Declaration of Conformity to the Directive and placing the product on the market in Europe.