Answer given by Mr Dalli on behalf of the Commission
Directive 93/42/EEC(1) concerning medical devices already requires manufacturers to demonstrate that the devices they place on the market are designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, including children where appropriate. The labelling, instructions for use and any other promotional materials accompanying the devices must reflect the use for which the device is intended and shall include, where appropriate, any restrictions on use, for example in terms of intended patients. Directive 93/42/EEC further specifies that devices emitting radiations shall be designed and manufactured in such a way that exposure of patients to radiation shall be reduced as far as compatible with the intended purpose.
In addition, Directive 93/42/EEC does not affect the application of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation(2), nor of Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure(3).
The Commission will carefully follow the US Food and Drug Administration's initiative in order to assess whether additional provisions should be incorporated into the European medical device legal framework.