Brussels, 30/11/2005 (Agence Europe) - The text of the revised 1993 directive on medical devices is now being translated. It is due to be adopted by written procedure during the first week of December. If the timetable is kept, the Parliament and the Council should rapidly begin their review. The Austrian president hopes to reach adoption of policy guidelines by June 2006.
The Commission's proposal, which is the result of broad consultation launched on 5 April 2005, aims not only at updating existing legislation but also at providing for a legal framework able to absorb upcoming technological innovations. The text also fills a gap in the field of “combined products” which calls for technological elements associated to basic human fabric material - for example, stents coated with vascular tissue and used to prevent the progression of stenosis. The directive on cells and tissue guarantees quality and security of products obtained and stored as well as their traceability but does not ensure follow-up when they enter a transformation process. The other legislative chapter concerning products from cellular and tissular engineering is the proposal for a regulation that has just been adopted by the Commission (EUROPE 9069) and which provides for these products used as medicine to be authorised through centralised procedure via the European Agency for the Evaluation of Medicinal Products (EMEA) in London. Hybrid by nature, the combined products were not covered. In future, they will be authorised by relevant Member State authorities on the basis of conformity criteria established by the new directive. In every case, the intervention of EMEA is required. It should, on one hand, ensure that the element of human origin has an auxiliary nature on the device (failing which, it would be a medicine subject to centralised AMM procedure) and, on the other, it should give an opinion on the use of the substance in question.
The proposal also extends the category of medical devices to software mainly used for the interpretation and storage of medical imagery. For made-to-measure devices, such as dental implants and false teeth in particular, a specific certificate of conformity should automatically be given to the patient. The text also imposes systematic clinical trials for some categories of devices before marketing as well as surveillance after marketing.
There is still no solution to one point. This is a problem posed by the re-use of medical devices designed to be used just once, a practice that occurs in many hospitals and which causes serious problems due to the risks entailed. Despite reiterated calls from the industry and Eucomed, the text does not help to find a solution. Under subsidiarity, Member States must ensure that authorised products are used correctly. In order to promote once-only use, the Commission has already drawn up guidelines in the past and could propose a recommendation to Member States in the future …. unless the Parliament and Council are unable to reach an agreement on introducing a binding provision.