In Vitro Diagnostic Overview

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.

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 to below 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.

BSI IVD CE Marking and Quality Management Service

BSI is a well-respected full scope Notified Body supporting clients across device categories including In Vitro Diagnostics Directive (IVDD), Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD). The BSI In Vitro CE marking and Quality Management services are designed to assist you in getting your device to global markets safely and in a timely manner. Our dedicated in- house IVD team has both industry and requlatory experience that enables a true understaning of your needs and challenges. We provide open commumication, 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.

BSI, a leading Notified Body, has a worldwide reputation for providing services that blends experience with safety and speed with predictability. Whether your product is simple or complex, BSI is committed to delivering professional, robust, fast and responsive IVD CE marking and ISO 13485 Quality Management services.

Benefits

• Combined Industry and Regulatory In-house Expertise in Wide-Range IVD Products
• Predictable, Fast, Efficient and Professional Service
• Speed-to-Market Programs (link: www.bsiamerica.com/Speed-to-Marketprograms)
• Full Scope in all 3 CE marking Medical Device Directives
• Understanding of how to Navigate the Regulatory Landscape
• Making the Transfer Process Timely and Seamless
• Responsiveness and Easy Access to In-house Expertise
• Use Industry Leaders for our Batch Testing

Product Expertise

BSI has an outstanding team of in- house experts with an average of 17 years IVD industry and regulatory experience in a wide-range of products. These leading experts have worked on all aspects of the product life cycle including R&D, manufacturing and quality to meet the demands of this exciting marketplace—both now and in the future. Our streamlined structure enables you to have one person to contact that understands your business, can answer your questions quickly and optimize the process in getting your IVD device to European markets.

Batch Testing

BSI works with two of the world-leading test laboratories, Paul Ehrlich Institut in Germany and Sanquin in the Netherlands to provide Annex II List A Verification of Manufactured Product testing. Companies using these laboratories that choose to transfer to BSI can keep their same testing facilities—this will enable a smoother and more seamless transition.

 

Do you need an IVD Notified Body?

The degree of involvement of a Notified Body, an independent third party, is generally proportional to the risks associated with a particular category of devices. 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.

Six steps to achieving registration with BSI:

The Directive classifies IVDs into four groups based on perceived risk. The first 3 require a Notified Body:

1. Annex II List A - High Risk
2. Annex II List B - Moderate Risk
3. Self-Testing - suitable for lay users (excludes self-test covered in Annex II)
4. General - Low Risk, the manufacturer self-declares conformity and does not require a Notified Body.