NOTE FROM THE EDITOR
A Mark of Confusion
As an editor, I know something about deadlines and the dysfunctional behaviour and general chaos they can produce. (You should see the state of my office right now.) One of the more extreme cases of deadline-induced denial that I have come across lately was recounted at the Medical Design & Manufacturing Exhibition and Conference in New York City in June. During a session devoted to the Medical Devices Directive (MDD), Eric Waters of Technology International Inc. (Richmond, VA, USA) mentioned that some US medical device manufacturers believe that US FDA has negotiated an exemption for US products to the 14 June 1998 MDD deadline. According to these companies, the European Commission will allow non-CE-marked US products to be marketed throughout the European Economic Area (EEA) after the official end of the transition period. EU companies, presumably, would not be afforded this luxury. I prefer to think that these manufacturers are not delusional but simply confused about how the end of the transition period is going to play out. In that regard, they're in good company.
At the recent Regulatory Affairs Professionals Society conference in Cannes, France, Norbert Anselmann, head of the medical devices sector at the European Commission's industrial affairs directorate, bluntly told attendees that there would be no grace period for medical devices sold in the EEA. "Products without a CE mark must have been placed on the market by 14 June," he said, "and placing the product in storage does not count." No grain of ambiguity there. Then he added that non-CE-marked products in the distribution chain prior to 14 June probably could continue to be sold until June 2001. Apparently, the distinction was not entirely clear to some attendees, and the confusion spilled over to the Medical Device Forum held in Weimar, Germany, in June. There, Anselmann reiterated the position and noted that a paper would be forthcoming from the commission on this topic. That paper has been issued and it should clarify any lingering uncertainties.
The discussion paper, which was released during the July 10 meeting of the Medical Device Expert Group in Brussels, states that non-CE-marked medical devices can be sold until June 2001 as long as they have been "placed on the market" by 14 June 1998. The document defines "placing on the market" as "the first making available in return for payment or free of charge of a device with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished. This refers to each individual product, rather than a particular device model."
This revised position takes some pressure off manufacturers, who had been haggling with distributors over delivery deadlines. Several distributors had announced that they would no longer accept non-CE-marked products, and in some cases, demanded that they be allowed to return unsold nonmarked merchandise to the manufacturer at the end of the transition period. Manufacturers hope that distributors, which now have three additional years to put products into service, will set less draconian conditions.
This document may still be subject to "updating," in the words of the European Commission, since it depends on the outcome of the legislative process aimed at amending the MDD within the context of the in vitro diagnostics directive. (The proposed IVD Directive, which is currently with the Council of Ministers, has been delayed over the wording of Article 19, an amendment to the MDD that involves the regulation of devices containing human tissue.)
Be that as it may, the discussion paper does clear up some of the rampant confusion of the past few months.
Then again, the French haven't commented on the proposal yet.
