Regulatory requirements Europe

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

Although there is significant difference in the detail, the regulatory requirements for evaluation and marketing authorisation of devices in Europe and the US both reflect a tiered response in relation to risk. This is illustrated in Table 10.4. In Europe,... 

Globalization of fhe pharmaceufical industry has created the need to harmonize the recommendations for fhe developmenf of new pharmaceuticals as well as the regulatory requirements. To address this need, in 1990, experts from the pharmaceutical industry and regulators from fhe United States, Europe, and Japan joined together to establish the ICFl... 

Tableting process, since being introduced in the early 1840s, has witnessed numerous changes in the form of stringent regulatory requirements for the excipients and product stability. Increasing regulatory pressure on purity, safety, and standardization of the excipients has catalyzed the formation of an international body, the International Pharmaceutical Excipients Council (IPEC) (13). IPEC is a tripartite council with representation from the United States, Europe, and Japan, and has made serious efforts to harmonize requirements for purity and functionality testing of excipients (14).

Harmonization of regulatory requirements was pioneered by the European Community (now the European Union) in the 1980s, as it moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonization was feasible. The harmonization process was then extended to include Japan and the United States. The ICH was formed from a government body and an industry association from each of these regions. These bodies and associations as listed by Molzon (2006) are ... 

Recommendations would provide a method for checking products marketed in the EU - whether produced in the EU or imported into the EU - including articles. This reinforces the principle (and World Trade Organisation (WTO) requirements) that imports should face the same regulatory requirements as products produced in Europe. A company placing a product on the EU market for... 

Since 1991, the International Congress of Harmonization (ICH 1, 2, 3, and 4, respectively, taking place in 1991, 1993, 1995, and 1997) has met to promote harmonization of regulatory requirements between its regions (Japan, US, and Europe) on Safety, Quality, and Efficacy of human pharmaceuticals. Both regulatory authorities and industry associations were involved in these discussions. 

At present, the pharmaceutical industry regulatory requirements refer to isolators specifically in the context of the manufacture of sterile products. There is no reference to their role in broader areas of crosscontamination and operator safety control. Within Europe, the current EU GMP clearly states that isolators might produce improvements in sterility assurance of sterile products, and that aseptic processing manufacturing isolators should be placed in at least a Grade D surrounding environment. The Food and Drug Administration (FDA) requirements are less well defined, but it is likely that in equivalent circumstances, they would like to see an isolator located in a class 100,000 or M6.5 environment In Operation. ... 

Europe Belgium The use of bioassays for effluent testing is not well established although currently being considered. There is no regulatory requirement for such testing. 

In the U.S., the industrial insurance carriers, e.g., Industrial Risk Insurers (IRI), Factory Mutual (EM), etc., may demand conformance to some of the various voluntary standards or to their own requirements. Europe, through CEN, appears to be taking a regulatory approach to safety which may lead to the enforcement of standards in the future. 

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