The systematic review carried out did not identify literature on standardised systems for post-introduction observation of new technologies, as conceived in this document, although it did identify various initiatives that could be included in post-introduction observation of new technologies, since they fulfil some of the proposed objectives. Within Europe it is important to document the Directive 2007/47/EC of the European Parliament and of the Council (22), which will become effective in March 2010, and requires for manufacturers to confirm conformity with the requirements concerning the characteristics and performances under normal conditions of use of the medical devices1 and the evaluation of the side-effects and acceptability of the benefit/risk ratio. As a general rule clinical evaluations must be performed. The evaluation of this data, where appropriate taking into account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:
In February 2008, an e-mail survey was sent to all members of the International Network of Agencies for Health Technology Assessment (INAHTA) distribution list, to identify all post-introduction observation activities under way in the respective countries of origin. The INAHTA is made up of 46 agencies belonging to 26 countries around the world, (http://www.inahta.org/Members). Response was obtained from 15 agencies in 9 countries (35%) including Spain. According to the information furnished by these agencies, four countries are currently undertaking post-introduction observation activities (Australia, Spain, Italy and France) though not in a structured manner. In the case of France, the technologies to be assessed and the post-introduction observation activities depend, in great measure, on specific recommendations of the CEDIT. In the Autonomous Region of Galicia, the decision to conduct a follow-up of technologies after their general approval is not based on specific criteria but on the recommendations issued by an Advisory Committee, which takes into account, among other aspects, the recommendations of the Galician Health Technology Assessment Agency (RD 1030/2006) (23). Taking into account the low response rate and the fact that the survey covers only HTA organisms many post-introduction observation activities might not have been identified.