Medical devices reform may introduce precautionary principle 

A 'precautionary principle' clause could be introduced in the EU's medical devices legislation. If the idea goes through it would mean that evidence on product risk would not be required to withdraw a product from the market but that the existence of 'reasonable doubt' would suffice. 

This is one of the new elements of a Commission non-paper, circulated among stakeholders in the framework of the review of the EU's legislation on medical devices. It has been highlighted as a major point of concern to industry.

The EU's directives covering medical devices (90/385/EEC on Active Implantable Medical Devices and 93/42/EEC on Medical devices) are currently undergoing a review. The Commission is preparing a new draft directive on the review of the medical devices directives, to be released later this year (see also

EurActiv 15 October 2003). 

The term "medical device" covers a very high number of products ranging from aids for disabled persons and dental devices to biotechnological products, such as tissue-engineered bone. The medical devices industry on the whole accounts for roughly 30 per cent of worldwide industry employing roughly 385 million people.

The review could result in a number of other changes to existing EU legislation. It could alter the current definition of medical devices, incorporate stricter rules on the re-use of medical devices which are intended for a single use only, and it may also re-classify surgical instruments to a higher risk category.

The medical devices review is on the agenda of the Medical Devices Expert Group in June and July. The proposal for the new directive is due to be published before the end of 2004. It will be adopted under the co-decision procedure.