A NOTE FROM THE EDITOR
The Future's Not What It Used to Be
Well, in our country," said Alice, "you'd generally get to somewhere else--if you ran very fast for a long time, as we've been doing."
"A slow sort of country," said the Queen. "Now here, you see, it takes all the running you can do to keep in the same place. If you want to get somewhere else, you must run at least twice as fast as that."
The above passage from Lewis Carroll's Through the Looking Glass came to mind as I was reading about the latest developments involving the medical device directives. Carroll may not be someone you would expect to see quoted in a trade publication, but as we lurch into the year when the Medical Devices Directive 93/42/EEC becomes mandatory, it seems that events are becoming, well, curiouser and curiouser.
As with so many things, it all begins in France. French authorities have been voicing strong reservations regarding the efficacy of the CE mark to guarantee the safety of medical devices with unflagging persistence during 1997. In addition to lobbying for tighter regulatory procedures at the European level, the current French government has introduced legislation that would require premarket approval for CE-marked medical devices before they can be placed on the national market. This shift from the light-touch precepts of the directives and the concomitant resurgence of national barriers has alarmed EUCOMED, which recently issued a position paper.
Titled "Reinforcing the Implementation of the Medical Devices Directive 93/42/EEC," this paper reaffirms the pan-European association's support of the new-approach directives while acknowledging that the system has some shortcomings that must be addressed. The primary aim, EUCOMED's director-general Michael Baker told EMDM recently, is to ensure that other member states do not follow the French example and consequently destroy the single market for devices. (See the MEDTEC conference summary on page 10 for more information on the EUCOMED paper.)
Since my discussion with Baker, the situation has continued to devolve. A clause has reportedly been added to the In Vitro Diagnostics Directive that has the potential to further weaken the single market for medical devices. Article 11c would give member states greater power to take interim measures to prohibit, restrict, or subject to additional requirements devices sold on their market. It has been reported that the clause is also included in the article amending the MDD and could apply to products covered by the Active Implantable Medical Devices Directive.
The IVD directive is now headed for a second reading in the European Parliament. Depending on whom you ask, the proposed directive either will sail through parliament or encounter a tempest of opposition. Potential obstacles may include parliamentary resistance to the European Council's more flexible position on the use of national languages and the classification of nearly all products in the high-risk category. Those in an optimistic frame of mind suggest that the IVD Directive could be adopted as early as mid-June.
Regardless of the outcome, it seems certain that the medical device directives as a whole will not leave the transitional period looking quite as brash and bold as they did entering it. As Baker has noted, it is ironic that this reversal of fortune for European industry comes at a time when so many of the world's leading economies have been inspired by the European model to reduce barriers to trade and move toward global harmonization.
Industry may find some solace in the knowledge that EUCOMED is running very fast in a valiant attempt to stay the course. "Our major defence must be directed at persuading the Commission and the competent authorities to take appropriate action to 'shore up' the implementation of the MDD in key areas," says Baker. The association's position paper outlines these points of principle, and it will be followed by what Baker calls a practical modus operandi to illustrate how these principles may be achieved. This document will be published shortly.
For more information on these papers, contact EUCOMED, rue du Collège Saint Michel 17, P.O. Box 8, B-1150 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909.
