Originally Published MDDI December 2004

NEWSTRENDS

EU Combination-Product Regulatory Paths Must Be Chosen Early

Erik Swain

Because there is no single agency or single directive that regulates combination products for the European market, an early-stage strategy there is key, says an EU regulatory expert.

In the United States, FDA's Office of Combination Products decides which of the agency's drug, device, or biologics review teams takes the lead in processing the application. No parallel system exists in Europe. Therefore, prompt and successful regulatory clearance depends on a firm's ability to apply the correct directives to its product, Thierry Chignon, principal consultant at Quintiles Consulting Europe (Perret, France), told attendees at September's MEDTEC conference in Galway, Ireland.

The Medicinal Products Directive and the Medical Devices Directives don't address specific combination-product concerns, he noted. But with no directive on combination products, manufacturers must determine which of the two other directives applies, or whether both do, and follow that particular directive, he said.

“The general rule is that a product is regulated either by the Medical Devices Directives or the Medicinal Products Directive,” Chignon said. “When a device is intended to administer a medicinal product, go with the Medical Devices Directives, without prejudice to the Medicinal Products Directive.” He said that if it is a single internal product intended exclusively for use in a given combination, and is not reusable, it is then regulated by the Medicinal Products Directive. However, he noted, the Medical Devices Directives apply as far as the safety and performance related to the device are concerned.

The major consideration is the primary intended purpose of the product, and the method by which the primary intended action is achieved, Chignon said. If that purpose involves a mechanical function, chances are the Medical Devices Directives apply. If it involves a chemical function, the Medicinal Products Directive most likely applies.

Manufacturers must communicate early about these issues with the notified body that they choose, Chignon said. Otherwise, notified bodies may pass on inadequate information to the relevant competent authorities. This could result in a late marketing clearance decision or, worse, a CE mark denial. “Notified bodies can be helpless spectators in this process. Negotiate with them about how active they should be,” he said.

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