Biological medical devices: it's all in the name.
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Equipment and Supplies↗
Biomedical subjects
I R Cutler
Publications and source records attributed to I R Cutler.
Not long to go: the end of the transition period approaches.
There are only seven months left until the end of the transition period for the Medical Device Directive. Manufacturers who have already achieved compliance and the CE mark can, in theory, look forward to the free circulation of their products throughout the European Union. This article examines the situation for manufacturers who have not yet complied and discusses the status of non-CE-marked products on and after 14 June 1998.
Equipment and Supplies↗
The drug-device interface.
The difference between a drug and a device appears clear, but there are instances when the distinction between a product being a drug or a device is blurred. By making reference to the EC Directives for medicinal products and medical devices, this article seeks to clarify the definition of a medical device that incorporates or administers a drug.
Drug Delivery Systems↗
Amendments to the medical device directive.
Variations in the transposition of the Medical Device Directive (MDD) by some countries has led to problems of interpretation and compliance, and there is still some way to go to achieve harmonization throughout Europe. This article suggests amendments to the MDD that should be introduced through the mechanism of the In Vitro Diagnostics Directive.
Consumer Product Safety↗