Links between regulators and standards developers

摘要

Standards play a critical role in underpinning both the development and the regulation of medical devices and in-vitro diagnostics (IVDs). The generation of standards is increasingly a complex global activity. In February 2004, WHO and the World Standards Cooperation brought together regulators and other stakeholders to consider whether the present arrangements are meeting the expectations and needs. In the majority of countries, the formal regulation of medical devices and of IVDs is relatively recent. Within Europe, individual countries had voluntary schemes stretching back over several decades. However, the statutory control of medical devices only began in the mid-1990s with the first of a series of EU Directives. Around this time, the Global Harmonization Task Force (GHTF) was created. Since its inception, the GHTF has been working on an ambitious programme of regulatory convergence. Within the GHTF model it is recognized that standards provide a vital tool to demonstrate compliance with the "Essential Principles". There is also a recognition that standards bodies should: (1) Ensure standards reflect current broadly applicable technology; (2) Ensure the suitability of standards; (3) Ensure a coherent standards programme linked to the GHTF Essential Principles.