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Medical Devices Directive and Medical Weighing Equipment

 1st Aug 2008

The UK position on the application of the Medical Devices Directive (MDD) to medical weighing equipment has been clear since 2002 when we discussed the matter with the Medical Devices Agency and they sent us the advice that we have published in the Members Area of the website. Their view was that weighing devices used in a medical environment are not normally covered by the MDD. The position in some other Members States is different however with the authorities there taking the view that the Medical Devices Directive was the prime control and that the NAWI Directive did not really apply.

It now appears that the European Commission has given this matter some thought and has come to the conclusion that where non-automatic weighing instruments are used for certain purposes the MDD applies whilst in all other cases the NAWI Directive applies.

In essence where a product is mainly intended for a medical purpose and meets the conditions for a medical device; and in order to achieve its main medical function it is assisted by a weighing function which is secondary compared with its medical function, for example computer tomagraph, baby incubator, dialysis system, then the Medical Devices Directive applies and the NAWI Directive does not.

The source of this opinion from the European Commission is being checked along with the validity of the documents that have been circulated and we will bring you full details and information as soon as we have it. If the documents prove to be valid we will place copies on the UKWF website.

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