Euro-U.S. Inspections to Begin by December

Originally Published MDDI July 2003

NEWSTRENDS

Erik Swain

A few years ago, the United States and the European Union planned to accept each other's inspections of medical device manufacturing facilities by 2001. Now their goal is to have the program in place by the end of 2003. But don't hold your breath. Before the goal becomes reality, an FDA official recently declared, a lot of training remains to be done.

The program, the Medical Device Annex of the Mutual Recognition Agreement (MRA), is to go into effect in December. The MRA will allow third parties in Europe to perform FDA inspections of European firms exporting medical devices to the United States. It will also allow third parties in the United States to perform the quality systems inspections of U.S. firms exporting devices to Europe. In some cases, third parties will be able to review low-risk devices as part of the 510(k) or CE mark process. The MRA was supposed to take effect in 2001, but the implementation period got extended for two years.

"It is not FDA acceptance or recognition of a CE mark," said FDA's William Sutton. "It's not a harmonization or equivalency. It's experts who can inspect, audit, and review, acting as surrogates for the importing party. This way, we can use more of our limited resources on higher-risk devices."

The agreement calls for the third parties, to be known as Conformance Assessment Bodies (CABs), to have their training completed by December 1, 2003. Sutton said six EU CABs now have procedures in place for performing independent audits and 510(k) reviews, and four of those have at least one auditor on staff who can perform them. But, as of early June, only one U.S. CAB had set procedures to perform European audits and reviews. "We hope to go abroad to do more training with U.S. CABs this summer," he added. "It's a resource-intensive job to implement."

Sutton is a member of the international staff of CDRH's Division of Small Manufacturers, International and Consumer Assistance. He spoke at the Medical Design & Manufacturing East conference held June 2–4 in New York City.

European CABs will send their reports to FDA for the agency to make a final decision. U.S. CABs must send their reports to a Notified Body (NB), a third-party firm accredited to assess how European firms are complying with the Medical Devices Directives.

Low- and moderate-risk devices will be eligible for premarket review by CABs. Currently, 97 product classes have been declared eligible for the program, and that list will soon expand to more than 400, Sutton said. All devices except in vitro diagnostics are eligible for inspections by CABs. The reason, Sutton said, is that "the [EU] IVD Directive is so new that we don't feel comfortable adding it at this time."

Many of the European CABs also serve as NBs, so EU industry may be able to have U.S. and EU inspections performed all at once. At the moment, Sutton said, U.S. industry will have to have multiple inspections. He said, however, that that could change if any U.S. CABs are accepted into the third-party inspection program outlined in the Medical Device User Fee and Modernization Act of 2002.

"It's been more difficult to show the benefit on the U.S. side," Sutton said. "That is why there is a big push on U.S. CABs to become third-party inspectors, so they can do two inspections at once like in the European Union."

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