EC Setting Standards for Medical Devices : Trade: Efforts continue despite the uncertainty over Maastricht Treaty ratification, U.S. manufacturers are told at conference.

A Brussels-based lobbyist told a group of medical device makers this week that, despite uncertainty over ratification of a treaty on closer political union in Western Europe, efforts to set standards for their products will proceed as planned.

Paul Adamson, a European Community lobbyist for the Health Industry Manufacturers Assn., said that recent financial and political turmoil surrounding the Maastricht Treaty may ironically benefit U.S. companies by simplifying doing business in Europe.

“It may mean that the community for the moment will go back to basics,” Adamson said. “There is still a tremendous amount of work to do in implementing the Single Market.”

The Maastricht Treaty is intended to establish closer political and economic ties among the 12 members of the European Community: Britain, France, Germany, Italy, Spain, Portugal, the Netherlands, Belgium, Luxembourg, Greece, Ireland and Denmark. The proposal, which was signed in December, 1991, in the small Dutch town of Maastricht, must be ratified by all 12 member nations to become a reality.

If that happens, the European Community will establish a single currency and central bank. Debate over the treaty has prompted some of the worst discord in years among European countries.

Adamson’s remarks came Monday during the opening of a three-day conference in Newport Beach, sponsored by the Health Industry Manufacturers Assn. HIMA Vice President Edward M. Rozynski said the conference, held at the Hyatt Newporter, is the first of its kind on the West Coast. About 140 representatives of medical device companies across the nation are attending the conference to learn the often-complicated approval process in Europe.

Conferees attending a variety of sessions on the first day of the conference were given lessons on how best to enter the European market, considered to be potentially the most lucrative for U.S. medical device companies.

With changes and controversies facing Europeans, Rozynski said, medical device makers should be aware of the benefits as well as the pitfalls of doing business on the Continent.

“This is a key time for the European Community,” Rozynski said.

Indeed, by Jan. 1, the European Community is poised to implement--with some exceptions--the Single Market Act, a wide-ranging agreement to allow free movement of goods, services, capital and labor within the EC’s borders. If that happens, only implantable medical devices, such as heart valves and implantable drug administrators, will be regulated under the Single Market Act, also known as the EC 92 Program.

But by 1995, most medical devices, including those made in the United States, will be regulated by the EC. U.S. companies hoping to do business there should have a well-structured plan to enter the market successfully, said Gordon R. Higson, chairman of Medical Technology Consultants, Europe Ltd. in London.

Higson told business representatives to expect a list of new regulations as the EC continues on its road to economic unity. He said a wide range of standards similar to those of the Underwriters’ Laboratories in the United States will likely be in place by the turn of the century.

Those standards cover decisions about what materials may be used in manufacturing, how the products may be packaged and what liability law will cover their use, Higson said.

“It is inexorable that we will create a tighter Europe,” Williams said. “But so far it’s been two steps forward and one step backward.”

William Davis, who represented Fullerton’s Beckman Instruments at the conference, said that efforts by the EC nations to harmonize their diverse regulations will eventually simplify European trade for U.S. companies.

Now, for instance, all U.S. companies must meet the various requirements of each of the 12 EC countries before selling products there.

“A concern for everyone,” Davis said, “is that there is harmonization. . . . We are all trying to work together to achieve that goal.”