Translation of "Montant d'échelle " (French → English) :

(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certifi ...[+++]cates issued by notified bodies, of the requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them.

(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certifi ...[+++]cates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them.

110. Reiterates its deep concern at the chronic underfinancing and particularly acute flexibility problems in the implementation of the Union's external activities, due to the unpredictable nature of external events, and recurring international crises and emergencies; stresses, accordingly, the need to close the gap between its ambitions and resources in foreign policy, by ensuring adequate financial resources and efficient flexibility mechanisms in order to enable the Union to respond to global challenges and unforeseen events; reiterates its request that budgetary implications deriving from any new commitments and tasks taken up by the Union must be additional to programmed amounts, ...[+++] in order to avoid jeopardising existing priorities;

109. Reiterates its deep concern at the chronic underfinancing and particularly acute flexibility problems in the implementation of the Union’s external activities, due to the unpredictable nature of external events, and recurring international crises and emergencies; stresses, accordingly, the need to close the gap between its ambitions and resources in foreign policy, by ensuring adequate financial resources and efficient flexibility mechanisms in order to enable the Union to respond to global challenges and unforeseen events; reiterates its request that budgetary implications deriving from any new commitments and tasks taken up by the Union must be additional to programmed amounts, ...[+++] in order to avoid jeopardising existing priorities;

110. Reiterates its deep concern at the chronic underfinancing and particularly acute flexibility problems in the implementation of the Union's external activities, due to the unpredictable nature of external events, and recurring international crises and emergencies; stresses, accordingly, the need to close the gap between its ambitions and resources in foreign policy, by ensuring adequate financial resources and efficient flexibility mechanisms in order to enable the Union to respond to global challenges and unforeseen events; reiterates its request that budgetary implications deriving from any new commitments and tasks taken up by the Union must be additional to programmed amounts, ...[+++] in order to avoid jeopardising existing priorities;

The payment institution's own funds shall amount to at least the sum of the following elements multiplied by the scaling factor k defined in paragraph 2, where payment volume (PV) represents one twelfth of the total amount of payment transactions executed by the payment institution in the preceding year: