In preparation for the New Machinery Directive which comes into force this December, we have been looking at typical scenarios that Machine users, builders and importers face in bringing machinery into compliance with the new directive. This article focuses on Machinery Imported from outside the EU through parent company…..
Machinery Imported from outside the EU through parent company
A medical device producer imports a machine used to apply a proprietary process in the production of medical devices. The machine which is not CE marked is supplied by a Special Purpose Machine Builder through the parent company of the device manufacturer. As the machine operator must observe the process carefully and intervene regularly to assure product quality a number of machine operating modes are required.
Interpretation under the new MD
The local company becomes the machine manufacturer and must CE mark the machine.
A risk assessment of the machine should be conducted to identify the hazards estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence, evaluate the risks, with a view to determining whether risk reduction is required and eliminate the hazards or reduce the risks.
If the machine design does not comply with the essential requirements of the directive it must be upgraded. In doing so, particular attention should be given to creating intelligent safety concepts for mode selection and to ensuring that operators can observe processes without bypassing the safety systems.
The upgrade designs must be documented in a technical file and a person "established in the community” designated to issue a declaration of conformance and prepare a CE marking plate.