Download Medical Device Safety: The Regulation of Medical Devices for by G.R Higson PDF

By G.R Higson

ISBN-10: 0750307684

ISBN-13: 9780750307680

Clinical equipment protection: The rules of clinical units for Public well-being and safeguard examines the customers for reaching international harmonization in scientific gadget legislation and describes a potential destiny worldwide approach. Unresolved problems are mentioned whereas strategies are proposed. a necessary e-book for all these excited about healthiness physics, engineering, and clinical regulatory affairs.

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Extra info for Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety

Sample text

Basic structure of the Directive There are 23 Articles and 12 Annexes in the Directive. The essence of the regulatory system is contained in the following Articles and Annexes. Article 1 Article 2 Article 3 Article 5 Article 11 Article 9 Article 17 Article 4 32 The Directive applies to medical devices and their accessories. Member States must ensure that medical devices can be marketed and used only if they are safe. A ‘safe’ device is one which complies with the essential requirements (ERs) contained in Annex I.

The degree of freedom left to Member States is controlled by the Directive itself; some (such as those on the reduction of waste) are aimed at moving the Community gradually towards a new position and have objectives described in general terms, leaving specific provisions almost entirely to the Member States, whereas technical Directives (such as those addressed to medical devices) may be written in such detail that Member States have little room to introduce national variations (for more information on Directives and other Community instruments, see Borchardt (1994) pp.

Sweden The Act of 7 May 1975 on the Control of Industrially Sterilized Single-Use Medical Devices (Sweden 75) designated the National Board of Health and Welfare (NBHW) as responsible for ensuring compliance with the Act and enabled NBHW to issue regulations for this purpose. The Board issued several directives and recommendations including a directive on labelling and recommendations on manufacture and sterilization. All sterile single-use devices had to be notified to NBHW but there was no approval process.

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