Press Release: EU moves to improve safety of medical devices

The safety of medical devices such as surgical equipment or implants is to be significantly improved after a proposal by the European Commission was adopted on 29 March 2007 by the European Parliament. There will be stricter rules for the use of potentially toxic materials, for which adequate labelling will be required. Furthermore the safe single use of devices is enhanced. A study will be done to see how better reprocessing of devices can be achieved. Apart from this, specialized medical software will fall under the scope of the new Medical Device Directives, which have been updated in the light of new technological developments. The European Parliament vote is based on a compromise, reached with the Council, which is expected to adopt the package shortly.