SOURCE: Underwriters Laboratories

February 08, 2007 18:28 ET

UL Improves EU Market Access for Self-Test Diagnostic Device Manufacturers

Expanded Scope of UL Notified Body Capabilities Under In Vitro Device Directive Expedites CE Mark Certification

NORTHBROOK, IL -- (MARKET WIRE) -- February 8, 2007 --Underwriters Laboratories Inc. (UL), a world leader in product safety testing and certification, announced today an expanded scope under the In Vitro Diagnostic Directive (IVDD) to provide EU market access via CE Mark Certification for self-test diagnostic device makers in general chemistry, immunology, endocrinology, biochemistry, urine and blood analysis.

"UL is excited to offer expanded services for manufacturers of most types of self-test devices seeking EU market access who therefore require assessment by a Notified Body to obtain the CE Mark," said Steve Buxton, BSc., Head of UL's IVDD Notified Body. "We have also redefined our scope as a Notified Body such that customers can better leverage our network of subcontractor expertise together with UL's specialized, in-house knowledge."

UL previously offered IVDD CE Mark certification services for self-test devices, primarily for pregnancy, fertility and cholesterol test devices. With this expanded capability, UL now offers a comprehensive scope of assessment for self-test devices under the IVDD.

"Broadening UL's IVD Notified Body Scope demonstrates our commitment to serving as an end-to-end partner for the IVD industry," said Anil Patel, General Manager of UL's Global Medical Business Unit. "Aligning our coverage with manufacturers' expanding portfolio of devices enables UL clients to enjoy the confidence and convenience of dealing with a single service provider for their regulatory needs."

Since December 2003, all products placed on the market in the European Economic Area have had to comply with the In Vitro Diagnostic Medical Devices Directive 98/79/EC and local member state laws. Manufacturers are also responsible for appointing an Authorized Representative in an EU state.

The product range under IVDD Annex III and IV encompasses self-test diagnostic devices for diabetes diagnosis and management; urine analysis; endocrinology, general biochemistry and chemistry, and general immunology; and also, under Annex IV, devices for detecting chlamydia infection and PSA. Excluded are so-called "policing" devices for blood alcohol, breathalyzer, and drug abuse analysis.

To learn more, visit www.ul.com/hitech/iso14971. For business inquiries contact: Tara Kambeitz, Global Marketing Manager, Medical Business Unit, 1-877-ULHELPS (1-877-854-3577) ext. 55610 or Tara.L.Kambeitz@us.ul.com.

About the In Vitro Diagnostic Medical Devices Directive

The purpose of the IVDD is to facilitate a single market with minimal technical barriers to trade. IVDD provides harmonizing rules on the safety, quality and performance of IVDs, and sets out a common regulatory environment for IVDs across Europe under which IVDs must meet certain essential requirements.

Government agencies known as Competent Authorities are responsible for the requirements of the IVDD being followed. Products must be registered with a Competent Authority before they can be sold in the EU. The UK Competent Authority is the Medicines and Healthcare products Regulatory Agency (MHRA).

For self-test devices, the manufacturer must submit details of the device design to an independent certification organization known as a Notified Body, which assesses the design in terms of its suitability for non-professional users. A manufacturer may alternatively follow a route available for higher-risk products that requires the firm's working practices to be verified by a Notified Body in addition to design review.

Products manufactured outside of the EU must have representation within a member state. This is the designated Authorized Representative who is legally responsible for registering the product with a Competent Authority for compliance and subsequent post-marketing vigilance for the product.

The CE Mark is the outward sign that a product meets all relevant European directives and is therefore permitted free market access. For IVDs, the CE Mark means that the device meets a defined set of minimum safety requirements listed in Annex I of the IVDD and is manufactured under a quality system.

The IVD Directive has a classification system such that moderate, high-risk and self-test IVDs all require a review by a Notified Body. The number beneath the CE mark identifies the Notified Body that has performed the review.

Reference: www.mhra.gov.uk -- "Guidance on the EC Medical Devices Directives."

Underwriters Laboratories Inc. (UL) is an independent, not-for-profit product safety certification organization that has been testing products and writing Standards for Safety for over a century. UL evaluates more than 19,000 types of products, components, materials and systems annually with 21 billion UL Marks appearing on 71,000 manufacturers' products each year. UL's worldwide family of companies and network of service providers includes 66 laboratory, testing and certification facilities serving customers in 104 countries. For more information, visit: www.UL.com.

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