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Additional resources for Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety
This law had enabling clauses which allowed it to be applied to almost everything that would now be regarded as a medical device. In practice, these powers were rarely used. The law was enforced by the Pharmaceutical Inspectorate which had limited expertise, and did little more than continue the operation of the Decree of 1960. The two major departures from this position were in respect of ionizing radiation and in vitro diagnostics. Ionizing radiation was regulated primarily by the Royal Decree of 28 February 1963 Regulating the General Protection of the Population and Workers Against the Danger of Ionizing Radiations (Belgium 63) which required authorization of diagnostic and therapeutic radiation emitting equipment; radioisotopes used for diagnosis or therapy and medical devices sterilized by irradiation.
1 The preferred approach of the Commission was to press for mutual recognition of national approvals—and this approach had been enormously strengthened by the 1979 decision of the Court of Justice in the ‘Cassis de Dijon’ 1 The European Commission is the executive and administrative arm of the European Community; the Council (of Ministers) is the decision-making body; the Court of Justice has the ﬁnal word on the interpretation of Community law. Harmonization in Europe 19 case (see page 24)—but the disparities in the national systems was too great for this approach to work and the Commission eventually came to realize that a series of harmonizing Directives would be needed.
On the other hand, the United Kingdom was not convinced that type testing bore any relation to the subsequent production and had pioneered quality assurance as a technique for ensuring the continued satisfaction of manufactured products of all kinds. The reconciliation of these opposing views was only achieved by allowing alternative methods of conformity assessment, as described in the next chapter. The Directive came into force in an optional form on 1 January 1993. A transitional period, during which devices could be legally marketed either by compliance with the Directive or with the pre-existing national regulations lasted until 31 December 1994.