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PubMed1996

The European legislation on medical devices.

The protection of health and safety of patients and users, is the main objective of the comprehensive, harmonised legislation created in the EU, in the area of medical devices. In this paper, a brief description of the legislative programme is presented,-giving details on the three medical device directives, as well as their transposition. A detailed analysis of the directives context follows, with the steps and actions that all involved parties have followed or need to follow to ensure their uniform application.

Equipment Safety↗
PubMed1995

[Effects of the medical products legislation on roentgen services].

On January 1, 1995 the law concerning medical products (Medizinproduktgesetz-MPG) came into force. It essentially regulates the production, circulation, and the putting into service of medical products as well as equipment. Among other things, the so-called active medical products include medical X-ray equipment whose aspects concerning atomic law remain covered by the radiation protection regulation for X-ray sources (RöV). Parallel to the coming into force of the MPG, the RöV was modified (Section 50, MPG), which in future might result in considerable consequences for the manufacturer, the operator, and the authorities.

Equipment Safety↗
PubMed1998

[Liability of the pneumonologist. Recent medical civil legislation].

The clinician engages his penal, private and administrative responsibilities whenever he performs a medical act. Common law applies for private practice, as is the case of most pneumologists. Actually, there is little common law jurisprudence directly concerning pneumological situations. We present here the current trends and recent decisions made by judges faced with cases engaging physician's responsibilities.

Ambulatory Care↗