Commentary: Evaluating and regulating device therapy

The current European regulatory framework—CE marking— might provide sufficient safeguards for electric toasters and kettles, but it is not adequate for treatments that can affect symptoms, health related quality of life, serious morbidity, and mortality.

There are many kinds of medical devices for myriad purposes in healthcare. All require an adequate regulatory framework to ensure that patients gain clear benefits and are not placed at unreasonable and avoidable risk. The so called class III devices have been defined by the US Food and Drug Administration as “those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”1 Examples include pacemakers, stents, and prostheses. Class III devices share many of the challenges of drug treatments, which historically have had more regulatory attention and rigour.

The FDA evaluates the safety and effectiveness of class III devices in a process parallel to that of drugs, although differences exist that some people think are inappropriate.2 In Europe, the process is different from that for drugs. Market access is granted if a device displays a CE mark. It is ultimately the manufacturer that decides whether …