Kennesaw-based CryoLife Inc. has received “CE” (product certification) for another innovative product, but it knows that it will take 30 to 90 days, if not longer, before it will be able to ship the product to Europe.
The CE mark, which in this case was granted by Lloyd’s Register Quality Assurance Limited of Croyden, England, allows for commercial distribution of the product within the European Union (EU) member countries.
“All U.S. manufacturers hope that the CE mark will make it easier to enter Europe, but the reality is that you still have to deal with the standards of each particular country,” Roy Vogeltanz, a spokesman for CryoLife, told GlobalFax in a telephone interview last week.
CryoLife is on the cutting edge of the development and commercialization of implantable living human tissues for use in cardiovascular, vascular and orthopedic surgeries.
The company already has received CE certification for its BioGlue Surgical Adhesive for use in vascular sealing and repair and for its stentless porcine heart values, which are distributed within the EU.
The most recent CE mark, awarded on Feb. 17, is for its BG 3000 Series Surgical Adhesive that provides surgeons with a ready-to-use delivery system for the use of BioGlue in the operating room.
Now that the product has been approved it can manufacture up to 300,000 of the cartridges annually rather than its current 10,000, according to Mr. Vogeltanz.
But the next phase of nation-by-nation approval, he added, will take from one to several months with France probably taking the longest time before the product may be exported there.
For more information, Mr. Vogeltanz may be reached by calling (800) 438-8285, fax, (770) 590-3754. The company’s Web site may be seen at http://www.cryolife.com