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Content archived on 2024-04-16

Legal aspects of medical devices: study on regulatory mechanisms for safety control

Objective

Investigation of legislative measures (EC Member States; EC) to enhance safety and quality of medical devices as well as their satisfactory functioning when used in health care.

Medical devices are increasingly applied in health care. They include any instrument, apparatus, implement machine, implant or other similar or related article intended for use in the diagnosis, care, treatment or prevention of disease in man or intended to affect the structure of functioning of the body of man (cf OTA definition). Medical devices range from the easy to use to very sophisticated and complex equipment. In vitro diagnostics are part of the medical devices sector.

From the patient's point of view, medical devices must meet particular requirements, such as suitability, effectiveness, acceptability and safety. Their growing number, diversity and technical variation as well as their complexity are some of the reasons why medical devices are more and more the subject of regulation. As in the case of medicines and drugs, both health aspects and industrial considerations are involved. From an industrial viewpoint, the complexity of national systems as well as international diversity of marketing regulations run counter to economic interests. The health and safety of the patient require a certain degree of protective (legislative) measures. From the public health point of view governments have certain responsibilities in this respect.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

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Call for proposal

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

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Coordinator

University of Utrecht
EU contribution
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Address
Nobelstraat 2-A
3512 EN Utrecht
Netherlands

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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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