A NOTE FROM THE EDITOR
Zen and the Art of Inventory Maintenance
The first time I heard about the practice of retrospective CE marking, I have to admit the concept sounded vaguely Zen to me. Something along the lines of "achieve your goal, then figure out how you got there." Granted, it is not likely to lead to spiritual enlightenment, but retrospective CE marking could give a new lease on life to non-CE-marked inventory, and that's nothing to sneeze at. The subject was broached during a daylong session on getting and keeping the CE mark presented at the Medical Design & Manufacturing Exposition that was recently held in Anaheim, CA,USA. Afterward I asked conference chair Howard Dobbs, group director of international regulatory affairs at Smith + Nephew North America (Memphis, TN), to share his thoughts on the practice.
The rationale for retrospective CE marking hinges on plain common sense, according to Dobbs. "A company is entitled to CE mark a product once its quality systems have been approved, the technical documentation has been compiled, and so forth," says Dobbs. "For the sake of convenience, let's say that technical documentation for a given product was signed off on 1 January 1997. Then you have to ask yourself what the status would be of the same product that was made on 31 December 1996. Technically, that product could not be CE marked because the documentation process had not been completed when the item was made. The fact is that the two products probably would be indistinguishable. And since that is the case, people have been looking at ways to go back and reconsider their inventory and justify retrospectively placing the CE mark on the product."
The process itself is fairly straightforward: before companies can place the CE mark on their products they must develop and follow an implementation plan that, among other things, demonstrates conformity with the essential requirements of the MDD. However, companies should not infer that they may simply slap on the CE mark without careful forethought, cautions Dobbs. "The process must be properly controlled and documented. Everyone must be clear about that."
The European Commission's recent decision to grant a three-year extension to non-CE-marked products that were legally placed on the market by 14 June 1998 has had little effect on reversing this trend. While the document may confer a legal status to such products, the question remains whether buyers will purchase them, especially if an equivalent product with a CE mark exists. "They may refuse to buy it because they have read the MDD and know that the transition period comes to an end on 14 June," says Dobbs. "And they may not know what the commission is talking about when it speaks of an extension until June 2001. And even if they do know about it, they may not believe it." It's not surprising then that manufacturers would choose to avoid this uncertainty altogether and explore alternative routes to CE marking their inventory.
There can be surprisingly few obstacles that stand in the way of a manufacturer who chooses this reverse route to compliance, according to Dobbs. "The product must be in the European distribution chain before 14 June. However, if a manufacturer can demonstrate that a product is equivalent to an already-CE-marked item, then he or she may be able to simply place the CE mark on it, following a controlled and documented process, of course." In the case of a low-risk Class I device, which does not require the involvement of a notified body to demonstrate compliance, "You wouldn't really have to ask anybody's permission," adds Dobbs. Where the procedure involves higher-risk devices that necessitate the services of a notified body, Dobbs stresses that the manufacturer should engage in an open and frank discussion with the third-party certification body to ensure that it is "favorably disposed to the procedure."
In other words, set your sights on the product, and the process will reveal itself. "Although retrospective CE marking is not specifically mentioned in the MDD," says Dobbs, "it certainly does make perfectly good sense, because there may be no difference between a product made yesterday and one that is made today." The customer also ultimately benefits, adds Dobbs, because any other course of action, except possibly selling the product in other parts of the world where CE marking is not required, would increase costs. "For that reason, I believe in many cases retrospective CE marking may be the sensible thing to do."
