Postmarketing controls

Once a device is on the market, it is subject to post-marketing controls. Regulators can place restrictions on the sale, distribution or use of devices and remove unsafe products from the market. In the past, device regulation, like drug regulation, has tended to focus on pre-market review, but post-marketing surveillance has taken on increasing importance in recent years. For instance, in Europe, manufacturers are required to have a systematic procedure to review experience gained from their devices in the post-production phase. European guidance indicates the importance of post-marketing studies in certain circumstances—such as the severity of the disease or the novelty of the technology—and indicates the range of approaches to data collection which can include 'extended follow-up of patients enrolled in the pre-market trials, and/or a prospective study of a representative subset of patients after the device is placed on the market. It can also take the form of open registries' (European Commission, 2004).

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