operational until 2001. More recently, in an effort to consolidate the texts, Directive 2000/747 was issued to bring together the four others and was an “updating directive.” More detailed implementing directives (there are five in Europe) will be enacted by the European Commission, taking into account the views of the member states. There is also Advanced Therapies Regulation 1394/2007, which is automatically binding on the member states and does not have to be transposed into national law.

Those directives are known in Europe as New Approach legislation. That legislation covers all consumer goods except pharmaceuticals. (Legislation concerning pharmaceuticals has been in place since 1965 at the European level since the thalidomide disaster.) The New Approach incorporates self-regulation and imposes the minimum level of regulation that is necessary to protect public health. The legislation reflects the dynamics of the device industry, which are different from those of the pharmaceutical industry.

Key features of the device regulation are that the legislation sets out what are known as the essential requirements, the core elements and procedures that companies need to have in place; sets out and defines the conformity assessment process (how independent bodies will assess whether a device is in conformity with the directives); and lays down precise obligations on the part of manufacturers. The legislation establishes “notified bodies” to evaluate devices and “competent authorities,” which are the agencies that control clinical trials, designate and supervise the notified bodies, and oversee postmonitoring surveillance. The legislation itself is underpinned by “normative standards.” Some are European standards, others are International Organization for Standardization (ISO) standards, and some are parts of a series of European guidelines called MEDDEV.

The European system is similar to the US system in that it is a risk-based device classification system, Jefferys said. In Europe, there are three classes but four categories:

  • Class I—self-regulation (and registration in each member state where they are marketed).

  • Class IIA—selective quality-system review (QSR) (for example, measuring devices and sterile products).

  • Class IIB—full QSR and targeted review of the design dossier (devices are defined in legislation and are not open to interpretation).

  • Class III—full design-dossier review.

Competent Authorities

Each member state in the EU has a competent authority; these are the same agencies that regulate pharmaceuticals (except in the Netherlands).

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