COLLAGEN CORP. TO MARKET CE MARKED PRODUCTS THROUGHOUT THE EUROPEAN ECONOMIC AREA FOLLOWING SUCCESSFUL ISO 9001/EN46001 CERTIFICATION; Collagen Corp. is at the forefront of U.S. Medical Device companies to comply with new European Medical Devices Directive.
Collagen Corporation followed standards established by the International Organization for Standardization ("ISO"), a world-wide organization with over 100 member countries, as well as EN46001 specific European Standards for medical devices to obtain its ISO 9001/EN46001 certification. Certification to the ISO 9001/EN46001 standards signifies that a company has met the required standards for quality management.
Collagen Corporation achieved certification well ahead of the required June 1998 deadline for medical device manufacturers who seek to market their products in the 18 countries that comprise the EEA. Additionally, Collagen Corporation is at the forefront of U.S. Medical Device firms to receive the right to use the CE mark on a biomaterial medical device product.
"Collagen Corporation is proud to be among the first U.S. Medical Device companies to be recognized as having the commitment to quality management and product safety that is necessary to affix the CE mark on its products," said A. Neville Pelletier, Collagen's vice president and managing director, Europe. "ISO 9001/EN46001 certification may cause a shift in the way Collagen's dermatology and plastic surgery products are marketed throughout most of Europe. Prior to receipt, Zyderm(R) I, Zyderm(R) II and Zyplast(R) Collagen Implants were classified as drugs in many European countries. This certification allows these products to be marketed as medical devices rather than drugs (these products are classified as medical devices in the United States) and such a classification change may, over time, result in reduced distribution costs for the company."
Collagen International, based in Lausanne, Switzerland, currently markets Collagen Replacement Therapy products (Zyderm(R) I, Zyderm(R) II and Zyplast(R) Collagen Implants) in many European markets, including the United Kingdom, France, Germany, Italy, Switzerland, Belgium and the Netherlands. All told, the products are marketed in 32 countries on five continents.
In the fiscal year ending June 30, 1995, Collagen International is expected to generate sales of approximately $26 million. The vast majority of those revenues are generated in Collagen's European markets.
Collagen Corporation recently announced that it has begun marketing in the United Kingdom the Trilucent(TM) Mammary Implant, manufactured by LipoMatrix, Incorporated of Neuchatel, Switzerland, a Collagen Corporation affiliate. LipoMatrix received ISO 9001/EN46001 certification and the right to affix the CE mark on its products approximately six months ago.
Collagen Corporation received certification to affix the CE mark on its products from TUV Product Service of Munich, Germany, which is authorized to serve as a Notified Body under European regulations. The Notified Body is an independent, impartial expert organization that is appointed to perform conformity assessments according to the Medical Devices Directive. Once a company receives certification from a Notified Body, the company is free to affix a CE mark and market its products in all 18 European nations in the EEA without undergoing individual country regulatory approvals.
The U.S. Food and Drug Administration is in the process of revising its Good Manufacture Practices ("GMP") regulations, which are expected to be similar to the ISO 9001/EN46001 standards. Companies certified to ISO 9001/EN46001 should be in an excellent position to comply with the revised GMP regulations when they go into effect.
Collagen Corporation is a technology-based company that develops, manufactures and markets biomedical devices for the treatment of defective, diseased, traumatized or aging human tissues.
CONTACT: Collagen International
A. Neville Pelletier or Jacques Mascaro, Ph.D.
David Foster, 415/354-4720
Edelman Public Relations
Jon Greer, 415/433-5381
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|Date:||Jul 6, 1995|
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