Traduction de «Dispositif d'alignement » (Français → Anglais) :

(g) the automatic alignment of the X-ray generator with the detector when the device is assembled;

(5) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of a specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned.

(5) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk classification, conformity assessment procedures and clinical evidence, and of the in vitro diagnostic medical device sector which require the adoption of a specific legislation, distinct from the legislation on other medical devices, whereas the horizontal aspects common to both sectors should be aligned without compromising the need for innovation in the Union .

Following the definition of the scope of the impact assessment, the Commission proceeded to the second round of public consultation which concentrated on four main substantive areas for improvement in the EU product safety regime: (i) procedures for mandating standards under the GPSD for non-harmonised products, (ii) harmonisation of safety evaluations, (iii) market surveillance cooperation and coordination, including the functioning of the EU Rapid Information System (RAPEX) and on-line distribution channels, and (iv) alignment with the Free Movement of Goods Package.

In particular, the Commission should be empowered to revise the threshold amounts for contracts by aligning them to the thresholds laid down in Directive 2004/17/EC and to amend certain reference numbers in the CPV nomenclature and the procedures for reference in notices to certain headings in the CPV, as well as the technical details and characteristics of devices for electronic receipt.

before the 2001 crisis the Commission did not subject the arrangements for prevention and control of the disease to adequate evaluation that took account of the changes in the risk factors; as the Commission did not carry out comprehensive evaluations and inspections in time, a number of weaknesses in the prevention and control arrangements concerning protective measures at borders, animal feed, animal movements and notification of the disease were not corrected before the outbreak of the epidemic; during the crisis the Commission rapidly took the necessary emergency measures, such as notification of the disease to the Member States, surveillance and slaughter of sheep which had been imported from the United Kingdom before the crisis beg ...[+++]an, and the closure of markets; the shortcomings in the system and in its application in the Member States in respect of the number of vets, notification of the disease and the speed at which culling was carried out were identified by the Commission during the crisis but it was too late to remedy them; the way in which the Community financing system was applied during the crisis led to inconsistencies: the reimbursement rates for the various animal diseases have been aligned only for the pig sector; there were delays in reimbursements to Member States; during the crisis, in the absence of a more clearly defined Community framework, the Member States were able to introduce a variety of systems to compensate farmers, based on varying methods of assessing the value of the animals before slaughter; after the crisis many shortcomings were remedied; nevertheless, the financial framework has not been revised and a number of Community measures are still inadequate with regard to the supervision of farms, notification of disease and speed in culling; these could compromise the effectiveness of the prevention and control arrangements in containing a future epidemic, while the Community would be obliged to reimburse the expenditure ...