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Medical-device manufacturers have a markedly different CE conformity marking experience compared to machine builders. Because the medical-device industry is regulated by the Food and Drug Administration (FDA), Washington D.C., it already has to meet stringent regulations concerning the safety of its products. Oftentimes, a manufacturer will have to make few, if any, design changes to the device it wishes to affix the CE marking, because FDA regulation tends to go above and beyond the fairly minimal requirements outlined in the directive.
Ortho Organizers had this incentive going for it when it decided to seek CE--marking certification in June 2007. The San Marcos, CA-based company of 140 employees manufactures orthodontic products and accessories. Approximately 40% of its sales are international, and a sizeable portion of that is within the EU. The company learned that some of its international salespeople were being questioned as to what the company's status was in obtaining the CE marking for its products. The Medical Device Directive was set to go into effect June 15, 2008, and any company not complying with it by that deadline would be subject to prosecution.
Obtaining CE marking, explained Dave Dunn, ISO management representative at Ortho Organizers, became a matter of whether or not the company could continue selling in the EU. "It was a business necessity for us. All of a sudden, this was becoming a reality." He was placed in charge of coordinating the CE-marking effort. His first step was to obtain a copy of the Medical Device Directive itself, and after he began reading it, his reaction was less than enthusiastic. "It was tough reading at first," he remembered. "It's a lot of words to describe very simple processes, actually. It could have been more user-friendly. And that's a common complaint I've heard throughout the industry-If this is what you want us to do, just say it, and we'll do it. Don't use three paragraphs to tell us one sentence (of information)."
After Dunn struggled through the directive, he called everyone he knew in the industry, seeking CE conformity marking help and advice. This included calling competitors, who surprisingly were very generous in advising Dunn on what to do and what not to do, and in discussing how they approached the directive. The problem was, the more people Dunn talked to, the more interpretations of the directive he heard, and the more confused be got on how his company should proceed. "I'd make a couple of phone calls, ask the same question, and get two different responses," he recalled. To cut through the conflicting advice, Dunn decided to go directly to the final interpreters of the directive: the competent bodies of the member countries Ortho Organizers shipped its goods to. Competent bodies assess products for compliance with the directives.
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