European Court makes firm ruling on in-house manufacture
This article was originally published in Clinica
A ruling last month by the European Court of Justice will have implications for all in-house manufactured medical devices and diagnostics. In-house manufacture is the manufacture of a product by a hospital for its own use. It has long been the subject of debate, especially in the UK, where it is commonly practised and is not covered by the Medical Devices Directive. This ruling makes it clear, however, that in-house manufacture is covered by the product liability directive.