The review of the EU’s medical devices directives could see the
introduction of the ‘precautionary principle’ and stricter rules on
the re-use of medical devices which are intended for a single use
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
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
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.