### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on large projects with clear eu added value in order to reach critical mass and reduce administrative burden for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro - credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through the establishment of a reserve to be allocated on an annual basis in order to respond to policy priorities . ### in line with the europe 2020 strategy , the programme should pursue a coherent approach to promoting employment and combating social exclusion and poverty . its implementation should be rationalised and simplified , notably through a set of common provisions including , inter alia , general objectives , typology of actions , monitoring and evaluation arrangements . the programme should also focus on small , medium and large projects with clear eu added value while aiming at ensuring that the administrative burden is at the lowest possible level for both the beneficiaries and the commission . in addition , greater use should be made of simplified cost options in particular for the implementation of mobility schemes . the programme should be a one - stop shop for microfinance providers , providing financing for micro credit , capacity building and technical assistance . lastly , the programme should provide for budgetary flexibility through allowing the possibility of shifting funds between the axes of the programme .


### actions eligible under the programme may be implemented jointly with other union instruments , provided that such actions meet the objectives of both the programme and the other instruments concerned . ### actions eligible under the programme may be implemented jointly with other union instruments , provided that such actions meet the objectives of both the programme and the other instruments concerned . the commission , in cooperation with the member states , shall ensure that clear demarcation lines are established between interventions under other instruments and the programme in order to avoid overlapping support and to ensure synergy .


### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the programme ' s results and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities . ### with a view to regular monitoring of the programme and making any adjustments needed to its policy and funding priorities , the commission shall draw up biennial monitoring reports and send them to the european parliament and the council . such reports shall cover the progress made in the implementation of the programme , the results achieved and the extent to which gender equality and anti - discrimination considerations , including accessibility issues , have been addressed through its activities .


### a mid - term evaluation of the programme shall be carried out by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . ### a mid - term evaluation of the programme shall be carried out no later than by the end of 2017 to measure progress made in meeting its objectives , to determine whether its resources have been used efficiently and to assess its union added value . the commission may , on the basis of the evaluation , propose the transfer of appropriations between the programme ' s axes .


### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , in particular children , the elderly and the disabled . ### the safety of products should be assessed taking into account all the relevant aspects , in particular their characteristics , composition and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability , and in particular children , the elderly and the disabled .


### manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or , where the size or nature of the product does not allow it , that indication is to be provided on the packaging or in a document accompanying the product . ### manufacturers and importers shall ensure that products bear an indication of the country of origin of the product and of the materials used in it or , where the size or nature of the product does not allow it , that indication is to be provided on the packaging or in a document accompanying the product .


### entangling nets with a mesh size equal to or greater than 250 mm , provided that : ### entangling and trammel nets with a mesh size equal to or greater than 250 mm , provided that :


### it shall be prohibited to conduct bottom trawling and fishing with static gear , including bottom set gill - nets and long - lines , within the areas enclosed by sequentially joining with rhumb lines the following coordinates , which shall be measured according to the wgs84 coordinate system : ### it shall be prohibited to conduct bottom trawling and fishing with static gear , including bottom set gill - nets and bottom set long - lines , within the areas enclosed by sequentially joining with rhumb lines the following coordinates , which shall be measured according to the wgs84 coordinate system :


### it is in the union’s interest to deepen its relations with partners who are playing an increasingly important role in the international economy and trade , in south - south trade and cooperation , in multilateral fora including group of twenty finance ministers and central bank governors , in global governance and in addressing challenges of global concern . the union needs to build comprehensive partnerships with new players on the international scene , in order to promote a stable and inclusive international order , pursue common global public goods , defend core interests of the union and increase knowledge of the union in these countries . ### it is in the union’s interest to deepen its relations with partners who are playing an increasingly important role in the international economy and trade , in south - south trade and cooperation , in multilateral fora including the world trade organization and the group of twenty finance ministers and central bank governors , in global governance and in addressing challenges of global concern . the union needs to build comprehensive partnerships with new players on the international scene , in order to promote a stable and inclusive international order , pursue common global public goods , defend core interests of the union and increase knowledge of the union in these countries .


### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures with developing countries where the union has significant interests in accordance with the objectives of this regulation . ### notwithstanding the specific focus on global players , the scope of this regulation should be worldwide enabling to support cooperation measures both with developed and developing countries where the union has significant interests in accordance with the objectives of this regulation .


### the union is committed in relations with its partners worldwide to promoting decent work for all along with ratification and effective implementation of the internationally recognised labour standards and multilateral environmental agreements . ### the union is committed in relations with its partners worldwide to promoting sustainable development , free and fair trade and decent work for all along with ratification and effective implementation of the internationally recognised labour standards and multilateral environmental agreements . this regulation should be used as a tool for supporting international competitiveness and contributing to a reduction in the risk of protectionism , while promoting european values and commercial interests , and as an instrument for free and fair trade that can bring into general practice the effective inclusion and implementation of social and environmental standards with partner countries , including promotion of new forms of employment policies and the creation of jobs meeting international labour organization decent work standards and growth opportunities for european industries and small and medium - sized enterprises .


### in particular , fighting climate change is recognised as one of the great challenges which the union faces and the area where urgent international action is necessary . in accordance with the intent stated in the commission communication “a budget for europe 2020” of increasing the climate related proportion of the union budget to at least 20% , this regulation should contribute to that goal . ### in particular , fighting climate change is recognised as one of the great challenges facing the union and the international community and is the area where urgent international action is necessary , considering that the union ' s goals in this area can only be achieved by cooperation with its main trading partners . in accordance with the intent stated in the commission communication “a budget for europe 2020” of increasing the climate related proportion of the union budget , this regulation should contribute to that goal .


### promotion of diversified cooperation and partnership initiatives within a single instrument should , furthermore , allow economies of scale , synergy effects , greater effectiveness , more streamlined decision - making and management and a high degree of visibility for the union’s external action . ### promotion of diversified cooperation and partnership initiatives within a single instrument should , furthermore , allow a forward - looking and innovative strategy on trade and investment taking into account the new challenges facing the union , economies of scale , synergy effects , greater effectiveness , more streamlined decision - making and management and a high degree of visibility for the union’s external action .


### in order to achieve the objectives of this regulation it is necessary to pursue a differentiated and flexible approach by developing models for cooperation with key partner countries which take into account their economic , social and political contexts and also the union’s specific interests , policy priorities and strategies , whilst maintaining the ability to intervene all over the world wherever needed . ### in order to achieve the objectives of this regulation it is necessary to pursue a differentiated and flexible approach by developing models for cooperation with key partner countries which take into account their economic , social and political contexts and also the union’s specific interests , policy priorities and strategies , whilst maintaining the ability to intervene all over the world wherever needed . the union should use an integrated approach with regard to trade , foreign , development , agricultural , environmental and research policies .


### the union should be able to respond in a flexible and timely manner to evolving and / or unforeseen needs in order to make its commitment to promote its interests in its relations with third countries more effective , by adopting special measures not covered by multi - annual indicative programmes . ### adequate programming , planning and enforcement measures and inter - institutional cooperation should be provided for in order to ensure that the union is able to respond in a flexible and timely manner to evolving and / or unforeseen needs in order to make its commitment to promote its interests in its relations with third countries more effective , and by adopting special measures not covered by multi - annual indicative programmes .


### in order to adapt the scope of this regulation to the rapidly evolving reality in third countries , the power to adopt acts in accordance with article 290 of the treaty of the functioning of the european union should be delegated to the commission in respect of the detailed areas of cooperation defined in the annex . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### modifications within the detailed areas of cooperation , adoption of multi - annual indicative programmes , and adjustments of the indicative financial allocation constitute non - essential elements of this regulation . consequently , in order to adapt the scope of this regulation to the rapidly evolving reality in third countries , the power to adopt acts in accordance with article 290 of the treaty of the functioning of the european union should be delegated to the commission in respect of the detailed areas of cooperation defined in the annex , adoption of multi - annual indicative programmes as defined in article 5 , and the indicative allocations per programme set out in annex ia . it is of particular importance that the commission should carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing - up delegated acts , should ensure simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation n° 182 / 2011 of 16 february 2011 laying down the rules and general principles concerning the mechanisms of control by member states of the commission’s exercise of implementing powers . taking into account the nature of those implementing acts , in particular their policy orientation nature or their financial implications , the examination procedure should in principle be used for their adoption , except for technical implementing measures of a small financial scale . ### in order to ensure uniform conditions for the implementation of this regulation , implementing powers should be conferred on the commission . those powers should be exercised in accordance with regulation n° 182 / 2011 of 16 february 2011 laying down the rules and general principles concerning the mechanisms of control by member states of the commission’s exercise of implementing powers . taking into account the nature of those implementing acts , in particular their financial implications , the advisory procedure should in principle be used for their adoption .


### this regulation establishes a partnership instrument for cooperation with third countries to advance and promote eu and mutual interests . the partnership instrument shall support measures that respond in an effective and flexible manner to objectives arising from the union ' s bilateral , regional or multilateral relationships with third countries and address challenges of global concern . ### this regulation establishes a partnership instrument for cooperation with third countries to advance and promote eu and mutual interests . the partnership instrument shall support measures that respond in an effective and flexible manner to objectives arising from the union ' s bilateral , regional or multilateral relationships with third countries , regions and territories and address challenges of global concern .


### implementing the international dimension of the &#8220 ; europe 2020&#8221 ; strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing collective approaches and responses to challenges of global concern such as energy security , climate change and environment . this objective shall be measured by the uptake of the &#8220 ; europe 2020&#8221 ; policies and objectives by key partner countries ; ### implementing the international dimension of the &#8220 ; europe 2020&#8221 ; strategy by supporting union ' s bilateral , regional and inter - regional cooperation partnership strategies , by promoting policy dialogues and by developing collective approaches and responses to challenges of global concern such as energy security , climate change and environment . this objective shall be measured by the uptake of the &#8220 ; europe 2020&#8221 ; policies and objectives by key partner countries and influence on policy formulation in those countries ;


### enhancing widespread understanding and visibility of the union and its role on the world scene by means of public diplomacy , education / academic cooperation and outreach activities to promote union’s values and interests . this objective may be measured , inter alia , by opinion surveys or evaluations . ### enhancing widespread understanding and visibility of the union and its role on the world scene by means of public diplomacy , education / academic cooperation and outreach activities to promote union’s values and interests . this objective may be measured by better perception and enhanced mutual understanding of the union in key partner countries illustrated , inter alia , by opinion surveys or evaluations .


### the union seeks to promote , develop and consolidate the principles of liberty , democracy , respect for human rights and fundamental freedoms and the rule of law on which it is founded by means of dialogue and cooperation with third countries . ### the union seeks to promote , develop and consolidate the principles of liberty , democracy , respect for human rights and fundamental freedoms and the rule of law on which it is founded by means of dialogue and cooperation with third countries , regions and territories .


### to enhance the impact of the union’s assistance , a differentiated and flexible approach shall be pursued , where appropriate , in designing cooperation with partner countries to take account of their economic , social and political contexts as and also of the union’s specific interests , policy priorities and strategies . ### to enhance the impact of the union’s assistance , a differentiated and flexible approach shall be pursued , where appropriate , in designing cooperation with partner countries , regions and territories to take account of their economic , social and political contexts as and also of the union’s specific interests , policy priorities and strategies .


### within their respective spheres of competence , the union and the member states shall promote a multilateral approach to global challenges and shall foster cooperation with international or regional organisations and bodies , including international financial institutions , united nations agencies , funds and programmes , oecd , and the group of twenty finance ministers and central bank governors and other bilateral donors . ### within their respective spheres of competence , the union and the member states shall promote a multilateral approach to global challenges and shall foster cooperation with international or regional organisations and bodies , including international financial institutions , the world trade organization , united nations agencies , funds and programmes , oecd , and the group of twenty finance ministers and central bank governors and other bilateral donors .


### in implementing this regulation , the union shall aim to ensure coherence and consistency with other areas of its external action , in particular the development cooperation instrument for developing countries , and with other relevant union’s policies when formulating policy , strategic planning and programming and implementing measures . ### in implementing this regulation , coherence and consistency shall be ensured with other areas of union external action , in particular the development cooperation instrument for developing countries , and with other relevant union’s policies when formulating policy , strategic planning and programming and implementation of measures . the union shall ensure that environmental , sustainable energy , social , employment and other welfare values are adequately considered in programming and implementation .


### measures financed under this regulation shall be based , where appropriate , on cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries and regions concerned , and shall also relate to areas linked to the union’s specific interests , policy priorities and strategies . ### measures financed under this regulation shall be based , where appropriate , on cooperation policies set out in instruments such as agreements , declarations and action plans between the union and the third countries , regions and territories concerned , and shall be aimed at improving their implementation capacity , on the union’s decisions , specific interests , policy priorities and strategies . the union ' s strategy for promoting trade , investment and economic cooperation shall be based on a thorough analysis of current trends in world trade , the union ' s internal and external development and the diversity of european enterprises , their know - how and their technological advances .


### multi - annual indicative programmes shall be adopted by the commission in accordance with the examination procedure referred to in article 15 of the common implementing regulation . this procedure shall also apply to substantial reviews which have the effect of changing significantly the strategy or its programming . ### the commission shall be empowered to adopt delegated acts in accordance with article 7 to adopt multi - annual indicative programmes . this procedure shall also apply to substantial reviews or adjustments which have the effect of changing significantly the strategy or its programming .


### the multi - annual indicative programmes shall set out the union’s strategic and / or mutual interests and priorities , the specific objectives and expected results . for countries or regions for which a joint framework document , laying down a comprehensive union strategy has been established , the multi - annual indicative programmes shall be based on this document . ### the multi - annual indicative programmes shall set out the union ' s strategy for the geographic area and area of cooperation concerned , the union’s strategic and / or mutual interests and priorities , the specific objectives , the expected results and the performance indicators . for countries or regions for which a joint framework document , laying down a comprehensive union strategy has been established , the multi - annual indicative programmes shall be based on this document .


### a reserve for unallocated funds may be established in the multi - annual indicative programmes . the allocation of these funds shall be decided in accordance with the common implementing regulation . ### a reserve for unallocated funds not exceeding 5% may be established in the multi - annual indicative programmes . the allocation of these funds shall be decided in accordance with the common implementing regulation .


### the examination procedure referred in paragraph shall not apply to non - substantial modifications to multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area or increasing or decreasing the size of the initial overall allocation by less than 20% , provided that these modifications do not affect the priority areas and objectives set out in the multi - annual indicative programmes . such adjustments shall be communicated within one month to the european parliament and to the council . ### the procedure referred in paragraph 1 shall not apply to non - substantial modifications to multiannual indicative programmes , making technical adjustments , reassigning funds within the indicative allocations per priority area or increasing or decreasing the size of the initial allocation by less than 10% , provided that these modifications do not affect the priority areas and objectives set out in the multi - annual indicative programmes . such adjustments shall be adopted by the commission in accordance with the advisory procedure referred to in article 15 of the common implementing regulation and shall be communicated within one month to the european parliament and to the council .


### the procedure referred in article 15 of the common implementing regulation may be applied for modifying multiannual indicative programmes where a swift response from the union is required . ### the procedure referred in article 15 of the common implementing regulation may be applied for modifying multiannual indicative programmes on duly justified imperative grounds of urgency where a swift response from the union is required .


### the delegation of powers referred to in article 4 shall be conferred for the period of validity of this regulation . ### the delegation of powers referred to in articles 4 , 5 and 8 shall be conferred for the period of validity of this regulation .


### the financial reference amount for implementation of this regulation for the period from 2014 to 2020 shall be eur 1&#160 ; 131&#160 ; 000&#160 ; 000 . annual appropriations shall be decided by the budgetary authority as part of the annual budget procedure within the limits set in the multiannual financial framework . ### the financial reference amount for implementation of this regulation for the period from 2014 to 2020 shall be eur 1&#160 ; 131&#160 ; 000&#160 ; 000 . the indicative financial allocation for the period 2014 - 2020 is laid down in annex ia . the commission shall be empowered to adopt delegated acts in accordance with article 7 to amend or supplement annex ia or to reallocate amounts between programmes . annual appropriations shall be decided by the budgetary authority as part of the annual budget procedure within the limits set in the multiannual financial framework .


### this regulation shall enter into force on the third day following its publication in the official journal of the european union . it shall apply from 1 january 2014 . ### this regulation shall enter into force on the third day following its publication in the official journal of the european union . it shall apply from 1 january 2014 to 31 december 2020 .


### the facilitation of trade relations and trade integration processes , including south - south , support to union investment flows and economic partnerships , including a focus on small and medium - sized enterprises ; ### the facilitation of trade relations and trade integration processes , including south - south , support to union investment flows and economic partnerships , including a focus on small and medium - sized enterprises , approximation of technical regulations and standardisation , intellectual property rights , protection of personal data , and best practices in economic , trade , tax and financial matters ;


### the promotion of initiatives and actions of union or mutual interest in areas such as climate change , environmental matters including biodiversity , resource efficiency , raw materials , energy , transport , science , research and innovation , employment and social policy , sustainable development , including promotion of decent work , and corporate social responsibility , south - south trade and cooperation , education , culture , tourism , information and communication technologies , health , justice , customs , taxation , financial , statistics and any other matter pertaining to the union’s specific interests or of mutual interest between the union and third countries ; ### the promotion of initiatives and actions of union or mutual interest in areas such as climate change , environmental matters including biodiversity , resource efficiency , raw materials , energy , transport , science , research and innovation , employment and social policy , sustainable development , including promotion of decent work , and corporate social responsibility , south - south trade and cooperation , education , culture , tourism , information and communication technologies , health , justice , customs , taxation , financial and statistics matters pertaining to the union’s specific interests or of mutual interest between the union and third countries ;


### 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 . ### 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 .


### in vitro diagnostic medical devices should , as a general rule , bear the ce marking to indicate their conformity with this regulation so that they can move freely within the union and be put into service in accordance with their intended purpose . member states should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this regulation . ### in vitro diagnostic medical devices should , as a general rule , bear the ce marking to indicate their conformity with this regulation so that they can move freely within the union and be put into service in accordance with their intended purpose . member states should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this regulation . however member states should be allowed to decide whether to restrict the use of any specific type of in - vitro diagnostic device in relation to aspects that are not covered by this regulation .


### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and notably human dignity , the integrity of the person , the protection of personal data , the freedom of art and science , the freedom to conduct business and the right to property . this regulation should be applied by the member states in accordance with those rights and principles . ### this regulation respects the fundamental rights and observes the principles recognized in particular by the charter of fundamental rights of the european union and notably human dignity , the integrity of the person , the principle of free and informed consent of the person concerned , the protection of personal data , the freedom of art and science , the freedom to conduct business and the right to property , as well as the convention on human rights and biomedicine as well as the additional protocol to that convention concerning genetic testing for health purposes . this regulation should be applied by the member states in accordance with those rights and principles .


### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the 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 certificates 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 performance studies ; the establishment of the udi system ; the information to be submitted for the registration of in vitro diagnostic 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 performance studies ; 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 . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union should be delegated to the commission in respect of the minimum requirements to be met by notified bodies , of the classification rules and of the documentation to be submitted for the approval of clinical performance studies ; the establishment of the udi system ; the information to be submitted for the registration of in vitro diagnostic 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 performance studies ; 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 . however , substantial elements of this regulation such as general safety and performance requirements , elements to be addressed in technical documentation , the minimum content of the union declaration of conformity , amending or supplementing the conformity assessment procedures , should only be amended through the ordinary legislative procedure . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### to allow economic operators , notified bodies , member states and the commission to adapt to the changes introduced by this regulation , it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application . it is particularly important that by the date of application , a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of in vitro diagnostic medical devices on the market . ### to allow economic operators , especially smes , to adapt to the changes introduced by this regulation and to ensure its proper application , it is appropriate to provide for a sufficient transitional period to enable organisational arrangements to be made . however , parts of the regulation that concern member states and the commission should be implemented as soon as possible . it is particularly important that a sufficient number of notified bodies is designated in accordance with the new requirements , as soon as possible , to avoid any shortage of in - vitro diagnostics medical devices on the market .


### in order to ensure a smooth transition to the registration of in vitro diagnostic medical devices , of relevant economic operators and of certificates , the obligation to submit the relevant information to the electronic systems put in place by this regulation at union level should become fully effective only 18 months after the date of application of this regulation . during this transitional period , article 10 and points and of article 12 of directive 98 / 79 / ec should remain in force . however , economic operators and notified bodies who register in the relevant electronic systems provided for at union level should be considered in compliance with the registration requirements adopted by the member states pursuant to those provisions of the directive to avoid multiple registrations . ### in order to ensure a smooth transition to the registration of in vitro diagnostic medical devices the electronic systems put in place by this regulation at union level should become operational as soon as possible . economic operators and notified bodies who register in the relevant electronic systems provided for at union level should be considered in compliance with the registration requirements adopted by the member states pursuant to those provisions of the directive to avoid multiple registrations .


### this regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription . ### this regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription . direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal . the following devices may only be supplied on a medical prescription : class d devices 2 ) class c devices in the following categories : devices for genetic testing ; companion diagnostics . the commission shall be empowered to adopt delegated acts in accordance with article 85 to decide on other category c tests after consultation with stakeholders .


### ' medical device ' means any instrument , apparatus , appliance , software , implant , reagent , material or other article , intended by the manufacturer to be used , alone or in combination , for human beings for one or more of the specific medical purposes of : – diagnosis , prevention , monitoring , treatment or alleviation of disease , – diagnosis , monitoring , treatment , alleviation of or compensation for an injury or disability , – investigation , replacement or modification of the anatomy or of a physiological process or state , – control or support of conception , – disinfection or sterilisation of any of the above - mentioned products , and which does not achieve its principal intended action by pharmacological , immunological or metabolic means , in or on the human body , but which may be assisted in its intended function by such means . ### ' medical device ' means any instrument , apparatus , appliance , software , implant , reagent , material or other article , intended by the manufacturer to be used , alone or in combination , for human beings for one or more of the specific direct or indirect medical purposes of : – diagnosis , prevention , monitoring , prediction , treatment or alleviation of disease , – diagnosis , monitoring , treatment , alleviation of or compensation for an injury or disability , – investigation , replacement or modification of the anatomy or of a physiological process or state , – control or support of conception , – disinfection or sterilisation of any of the above - mentioned products , – providing information concerning direct or indirect impacts on health , and which does not achieve its principal intended action by pharmacological , immunological or metabolic means , in or on the human body , but which may be assisted in its intended function by such means .


### - concerning a congenital abnormality ; ### – concerning congenital physical or mental impairments ,


### ‘ device for self - testing’ means any device intended by the manufacturer to be used by lay persons ; ### ‘ device for self - testing’ means any device intended by the manufacturer to be used by lay persons , including testing services offered to lay persons by means of information society services ;


### ' manufacturer ' means the natural or legal person who manufactures or fully refurbishes a device or has a device designed , manufactured or fully refurbished , and markets that device under his name or trademark . ### ' manufacturer ' means the natural or legal person with responsibility for the design , manufacture , packaging and labelling of a device before it is placed on the market under that person ' s own name , regardless of whether those operations are carried out by that person or on that person ' s behalf by a third party . the obligations of this regulation to be met by manufactures also apply to natural or legal persons who assemble , package , process , fully refurbish or label one or more ready - made products and / or assign to them their intended purpose as devices with a view to their being placed on the market under that person ' s own name or trademark .


### ' health institution ' means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health ; ### ' health institution ' means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health ; excluding commercial clinical service labs ;


### ' conformity assessment body ' means a body that performs third - party conformity assessment activities including calibration , testing , certification and inspection ; ### ' conformity assessment body ' means a body that performs third - party conformity assessment activities including testing , certification and inspection ;


### ' calibrators and control materials ' means any substance , material or article intended by the manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended purpose of that device ; ### ' control material ' means a substance , material or article intended by its manufacturer to be used to verify the performance characteristics of a device ;


### ‘ device deficiency’ means any inadequacy in the identity , quality , durability , reliability , safety or performance of a device for performance evaluation , including malfunction , use errors or inadequacy in the information supplied by the manufacturer ; ### ‘ device deficiency’ means any inadequacy in the identity , quality , stability , reliability , safety or performance of a device for performance evaluation , including malfunction , use errors or inadequacy in the information supplied by the manufacturer ;


### making available of devices , obligations of economic operators , ce marking , free movement ### making available and application of devices , obligations of economic operators , ce marking , free movement


### demonstration of conformity with the general safety and performance requirements shall be based on clinical evidence in accordance with article 47 . ### demonstration of conformity with the general safety and performance requirements shall include clinical evidence in accordance with article 47 .


### that the device is labelled in accordance with this regulation and accompanied by the required instructions for use and eu declaration of conformity ; ### that the device is labelled in accordance with this regulation and accompanied by the required instructions for use ;


### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken . ### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and , within their respective area of activity , make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken .


### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken . ### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that , within the limits of its respective activities , the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken .


### the first subparagraph shall not apply to any person who , while not considered a manufacturer as defined in number of article 2 , assembles or adapts a device already on the market to its intended purpose for an individual patient . ### the first subparagraph shall not apply to any person who , while not considered a manufacturer as defined in number of article 2 , assembles or adapts a device already on the market to its intended purpose for an individual patient or a specific limited group of patients within a single healthcare institution .


### in addition , where a reference laboratory is designated in accordance with article 78 , the notified body performing the conformity assessment shall request that reference laboratory to verify compliance of the device with the applicable cts , when available , or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent , as specified in section 5 . 4 of annex viii and in section 3 . 5 of annex ix . ### in addition , where a reference laboratory is designated in accordance with article 78 , the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable cts , as specified in section 5 . 4 of annex viii and in section 3 . 5 of annex ix . laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and specificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established infection .


### in addition , for devices for self - testing and near - patient testing , the manufacturer shall fulfil the supplementary requirements set out in section 6 . 1 of annex viii . ### in addition , for devices for self - testing the manufacturer shall fulfil the supplementary requirements set out in section 6 . 1 of annex viii .


### the demonstration of conformity with the general safety and performance requirements set out in annex i , under normal conditions of use , shall be based on clinical evidence . ### the demonstration of conformity with the general safety and performance requirements set out in annex i , under normal conditions of use , shall be based on clinical evidence , or additional safety data for general safety and performance requirements not covered by clinical evidence .


### all clinical performance studies shall be designed and conducted in a way that the rights , safety and well - being of the subjects participating in such clinical performance studies are protected and that the clinical data generated in the clinical performance study are going to be reliable and robust . ### all clinical performance studies shall be designed and conducted in a way that the rights , safety and well - being of the subjects participating in such clinical performance studies are protected and that the clinical data generated in the clinical performance study are going to be reliable and robust . such studies shall not be conducted if the risks associated with the investigation are not medically justifiable in terms of the potential benefits of the device .


### for interventional clinical performance studies , as defined in number of article 2 , and for other clinical performance studies , where the conduct of the study , including specimen collection , involves invasive procedures or other risks for the subjects of the studies , the requirements set out in articles 49 to 58 and in annex xiii shall apply , in addition to the obligations laid down in this article . ### for interventional clinical performance studies , as defined in number of article 2 , and for other clinical performance studies , where the conduct of the study , including specimen collection , involves invasive procedures or other risks for the subjects of the studies , the requirements set out in articles 49 to 58 and in annex xiii shall apply , in addition to the obligations laid down in this article . the commission shall be empowered to adopt delegated acts in accordance with article 85 concerning the provision of a list with negligible risks , which allows a derogation to be made from the relevant article .


### the member states shall take all appropriate measures to encourage healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up . ### the member states shall take all appropriate measures to encourage healthcare professionals , including doctors and pharmacists , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up .


### the national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions , taking into account criteria such as causality , detectability and probability of recurrence of the problem , frequency of use of the device , probability of occurrence of harm and severity of harm , clinical benefit of the device , intended and potential users , and population affected . they shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action . they shall monitor the manufacturer ' s investigation of the incident . ### the national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions , taking into account criteria such as causality , detectability and probability of recurrence of the problem , frequency of use of the device , probability of occurrence of harm and severity of harm , clinical benefit of the device , intended and potential users , and population affected . they shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action . they shall monitor the manufacturer ' s investigation of the serious incident .


### to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this regulation , in particular regarding the designation and monitoring of notified bodies , application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies ; ### to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this regulation .


### to carry out appropriate tests on samples of manufactured class d devices or batches of class d devices , as provided for in the section 5 . 7 of annex viii and in section 5 . 1 of annex x ; ### to carry out appropriate laboratory tests on samples of manufactured class d devices or batches of class d devices , as provided for in the section 5 . 7 of annex viii and in section 5 . 1 of annex x ;


### to provide scientific advice regarding the state of the art in relation to specific devices , or a category or group of devices ; ### to provide scientific advice and technical assistance regarding the definition of the state of the art in relation to specific devices , or a category or group of devices ;


### to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures and market surveillance ; ### to contribute to the development of appropriate testing and analysis methods to be applied for conformity assessment procedures , in particular for batch verification of class d devices and for market surveillance ;


### to contribute to the development of standards at international level ; ### to contribute to the development of common technical specifications as well as of international standards


### to have appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated ; ### to have appropriately qualified staff with adequate knowledge and experience in the field of the in vitro diagnostic medical devices for which they are designated ; appropriate knowledge and experience shall be based on - experience of assessing high - risk ivds and of carrying out the relevant laboratory tests ; - in - depth knowledge of high - risk in - vitro diagnostic medical devices and relevant technologies ; - proven laboratory experience in one of the following areas : testing or calibration laboratory , supervisory authority or institution , national reference laboratory for class d devices , quality control of in - vitro diagnostic medical devices , development of reference materials for ivds , calibration of diagnostic medical devices ; laboratories or blood banks which experimentally assess and use high - risk ivds or , where applicable , manufacture them in - house ; - knowledge and experience of product or batch testing , quality checks , design , manufacture and use of ivds ; - knowledge of the health risks faced by patients , their partners and recipients of blood / organ / tissue donations / preparations associated with the use and , in particular , malfunctioning of high - risk ivds ; - knowledge of this regulation and of applicable laws , rules and guidelines , knowledge of the common technical specifications , applicable harmonized standards , product - specific requirements and relevant guidance documents ; - participation in relevant external and internal quality assessment schemes organised by international or national organisations .


### where notified bodies or member states request scientific or technical assistance or a scientific opinion from an eu reference laboratory , they may be required to pay fees to wholly or partially cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions . ### where notified bodies or member states request scientific or technical assistance or a scientific opinion from an eu reference laboratory , they shall be required to pay fees to wholly cover the costs incurred by that laboratory in carrying out the requested task according to a set of predetermined and transparent terms and conditions .


### article 23 and and article 43 shall apply from [ 18 months after date of application referred to in paragraph 2 ] ; ### article 23 shall apply from . . . * ; __________________________ * oj : please insert the date : 18 months after the entry into force of this regulation


### protection against the risks posed by devices intended by the manufacturer for self - testing or near - patient testing 16 . 1 the devices intended for self - testing or near - patient testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user ' s technique and environment . the information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply . 16 . 2 the devices intended for self - testing or near - patient testing shall be designed and manufactured in such a way as to - ensure that the device is easy to use by the intended user at all stages of the procedure ; and - reduce as far as possible the risk of error by the intended user in the handling of the device and , if applicable , the specimen , and also in the interpretation of the results . 16 . 3 the devices intended for self - testing and near - patient testing shall , where reasonably possible , include a procedure by which the intended user can : - verify that , at the time of use , the device will perform as intended by the manufacturer ; and - be warned if the device has failed to provide a valid result . ### protection against the risks posed by devices intended by the manufacturer for self - testing 16 . 1 the devices intended for self - testing shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to the intended user and the influence resulting from variation that can be reasonably anticipated in the intended user ' s technique and environment . the information and instructions provided by the manufacturer shall be easy for the intended user to understand and apply . 16 . 2 the devices intended for self - testing shall be designed and manufactured in such a way as to - ensure that the device is easy to use by the intended user at all stages of the procedure ; and - reduce as far as possible the risk of error by the intended user in the handling of the device and , if applicable , the specimen , and also in the interpretation of the results . 16 . 3 the devices intended for self - testing shall , where reasonably possible , include a procedure by which the intended user can : - verify that , at the time of use , the device will perform as intended by the manufacturer ; and - be warned if the device has failed to provide a valid result .


### residual risks which are required to be communicatedto the user and / or other person shall be included as limitations , contraindications , precautions or warnings in the information supplied by the manufacturer . ### residual risks which are required to be communicatedto the user and / or other person shall be included as limitations , precautions or warnings in the information supplied by the manufacturer .


### the device’s intended purpose : ### the device’s intended purpose which may include :


### 2 . 5 . the personnel responsible for carrying out product related review shall have the following proven qualification : ### 2 . 5 . the personnel responsible for carrying out product related review shall have an appropriate qualification certified by a competent authority of a member state . appropriate qualifications are , for example : :


### 2 . 6 . the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have the following proven qualification : ### 2 . 6 . the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have an appropriate qualification certified by a competent authority of a member state . appropriate qualifications are , for exampl : :


### detecting the presence of an infectious agent , if there is a significant risk that an erroneous result would cause death or severe disability to the individual or foetus being tested , or to the individual ' s offspring ; ### detecting the presence of an infectious agent , if there is a significant risk that an erroneous result would cause death or severe disability to the individual , foetus or embryo being tested , or to the individual ' s offspring ;


### screening for congenital disorders in the foetus . ### screening for congenital disorders in the foetus or embryo .


### 4 the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , of the manufacturer ' s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 . or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which shall not be disclosed to the manufacturer . ### 4 the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , of the manufacturer ' s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which shall not be disclosed to the manufacturer . the notified body shall carry out such inspections at least once every three years .


### 7 . to verify conformity of manufactured devices classified as class d , the manufacturer shall carry out tests on the manufactured devices or each batch of devices . after the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests . furthermore , the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre - agreed conditions and modalities which shall include that the notified body or the manufacturer , in regular intervals , shall send samples of the manufactured devices or batches of devices to a reference laboratory , where designated in accordance with article 78 , to carry out appropriate tests . the reference laboratory shall inform the notified body about its findings . ### 7 . to verify conformity of manufactured devices classified as class d , the manufacturer shall carry out tests on the manufactured devices or each batch of devices . after the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests . furthermore , the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre - agreed conditions and modalities which shall include that the notified body or the manufacturer shall send samples of the manufactured devices or batches of devices to a reference laboratory , where designated in accordance with article 78 , to carry out appropriate tests . the reference laboratory shall inform the notified body about its findings .


### 1 . in the case of devices classified as class d , the manufacturer shall carry out tests on the manufactured devices or each batch of devices . after the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests . furthermore , the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre - agreed conditions and modalities which shall include that the notified body or the manufacturer , in regular intervals , shall send samples of the manufactured devices or batches of devices to a reference laboratory , where designated in accordance with article 78 , to carry out appropriate tests . the reference laboratory shall inform the notified body about its findings ### 1 . in the case of devices classified as class d , the manufacturer shall carry out tests on the manufactured devices or each batch of devices . after the conclusion of the controls and tests he shall forward to the notified body without delay the relevant reports on these tests . furthermore , the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre - agreed conditions and modalities which shall include that the notified body or the manufacturer shall send samples of the manufactured devices or batches of devices to a reference laboratory , where designated in accordance with article 78 , to carry out appropriate laboratory tests . the reference laboratory shall inform the notified body about its findings


### 1 . examination of the design of devices for self - testing and near - patient testing classified as class a , b or c ### 1 examination of the design of devices for self - testing classified as class a , b or c and of devices for near patient testing classified as class c


### the manufacturer of devices for self - testing or near - patient testing classified as class a , b and c shall lodge with the notified body referred to in section 3 . 1 an application for the examination of the design . ### the manufacturer of devices for self - testing classified as class a , b and c and of devices for near patient testing classified as class c shall lodge with the notified body referred to in section 3 . 1 an application for the examination of the design .


### the notified body shall give due consideration to the opinion , if any , expressed by the medicinal products competent authority concerned or the ema when making its decision . it shall convey its final decision to the medicinal products competent authority concerned or to the ema . the design - examination certificate shall be delivered in accordance with point of section 6 . 1 . ### the notified body shall give due consideration to the opinion , if any , expressed by the medicinal products competent authority concerned or the ema on the scientific suitability of the companion diagnostic when making its decision . if the notified body deviates from that position , it shall justify its decision to the medicinal products competent authority concerned or to the ema . if no agreement is reached , the notified body shall inform the mdcg thereof . the design - examination certificate shall be delivered in accordance with point of section 6 . 1 .


### the power to adopt individual decisions implementing the sanction mechanisms set out in this regulation should be conferred on the council . as part of the coordination of the economic policies of the member states conducted within the council as specified in article 121 of the treaty , these individual decisions are an integral follow - up to the measures adopted by the council in accordance with articles 121 and 126 of the treaty and regulations no 1466 / 97 and no 1467 / 97 . ### the power to adopt individual decisions implementing the sanction mechanisms set out in this regulation should be conferred on the council . as part of the coordination of the economic policies of the member states conducted within the council as specified in article 121 tfeu , these individual decisions are an integral follow - up to the measures adopted by the council in accordance with articles 121 , 126 and 148 tfeu and regulations no 1466 / 97 and no 1467 / 97 .


### this regulation sets out a system of sanctions for enhancing the enforcement of the preventive and corrective parts of the stability and growth pact in the euro area . ### this regulation sets out a system of incentives and sanctions for enhancing the enforcement of the preventive and corrective parts of the stability and growth pact in the euro area .


### if the council addresses to a member state a recommendation in accordance with article 121 of the treaty to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council addresses to a member state a recommendation in accordance with article 121 tfeu to take the necessary adjustment measures in the event of persisting or particularly serious and significant deviations from prudent fiscal policy - making as laid down in article 6 of regulation no 1466 / 97 , the lodging of an interest bearing deposit shall be imposed by the council , acting on a proposal from the commission and after consulting the european parliament . the decision shall be deemed to be adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### if the council decides in accordance with article 126 of the treaty that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 tfeu that an excessive deficit exists in a member state , the lodging of a non - interest - bearing deposit shall be imposed by the council , acting on a proposal from the commission and after consulting the european parliament . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to reduce the amount of the non - interest - bearing deposit or to cancel it . ### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic or social circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 tfeu , propose to reduce the amount of the non - interest - bearing deposit or to cancel it .


### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to cancel or to reduce the amount of the fine . ### by derogation from paragraph 2 of this article , the commission may , on grounds of exceptional economic or social circumstances or following a reasoned request by the member state concerned addressed to the commission within ten days of adoption of the council decision in accordance with article 126 of the treaty , propose to cancel or to reduce the amount of the fine .


### if the council decides in accordance with article 126 of the treaty that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission , shall decide that the member state shall pay a fine . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 of the treaty . ### if the council decides in accordance with article 126 tfeu that the member state has not taken effective action in response to a council recommendation within the period laid down , the council , acting on a proposal from the commission and after consulting the european parliament , while taking due account of account of article 9 tfeu , in particular with regard to the promotion of a high level of employment , the guarantee of adequate social protection and the fight against social exclusion and of the union ' s growth and jobs objectives , shall decide that the member state shall pay a fine . the decision shall be deemed adopted by the council unless it decides by qualified majority to reject the proposal within ten days of the commission adopting it . the council may amend the proposal in accordance with article 293 tfeu .


### in deciding on the design of new ports and terminals , and as part of major refurbishments , the bodies responsible for those facilities should , where necessary , take into account the needs of disabled persons and persons with reduced mobility . similarly , carriers should , where necessary , take such needs into account when deciding on the design of new and newly refurbished passenger ships in accordance with directive 2009 / 45 / ec of the european parliament and of the council of 6 may 2009 on safety rules and standards for passenger ships and directive 2006 / 87 / ec of the european parliament and of the council of 12 december 2006 laying down technical requirements for inland waterway vessels . ### in deciding on the design of new ports and terminals , and as part of major refurbishments , the bodies responsible for those facilities should take into account the needs of disabled persons and persons with reduced mobility , paying particular consideration to ‘ design for all’ requirements . carriers should take such needs into account when deciding on the design of new and newly refurbished passenger ships in accordance with directive 2009 / 45 / ec of the european parliament and of the council of 6 may 2009 on safety rules and standards for passenger ships and directive 2006 / 87 / ec of the european parliament and of the council of 12 december 2006 laying down technical requirements for inland waterway vessels .


### weather conditions endangering the safe operation of the ship should include , but not be limited to , strong winds , heavy seas , strong currents , difficult ice conditions and extremely high or low water levels . ### weather conditions and natural disasters endangering the safe operation of the ship should include , but not be limited to , strong winds , heavy seas , strong currents , difficult ice conditions , extremely high or low water levels , hurricanes and tornados , fires , floods and earthquakes .


### extraordinary circumstances should include , but not be limited to , terrorist attacks , labour conflicts , landing any sick , injured or dead person , search and rescue operations at sea or on inland waterways , measures necessary to protect the environment , decisions taken by traffic management bodies or port authorities , or decisions by the competent authorities with regard to public order and safety as well as to cover urgent transport needs . ### extraordinary circumstances should include , but not be limited to , terrorist attacks , wars and military or civil armed conflicts , uprisings , military or illegal confiscations , labour conflicts , landing any sick , injured or dead person , search and rescue operations at sea or on inland waterways , measures necessary to protect the environment , decisions taken by traffic management bodies or port authorities , or decisions by the competent authorities with regard to public order and safety as well as to cover urgent transport needs .


### passengers should be fully informed of their rights under this regulation , so that they can effectively exercise those rights . rights of passengers should include the receipt of information regarding the passenger service or cruise before and during the journey . all essential information provided to passengers should also be provided in formats accessible to disabled persons and persons with reduced mobility . ### passengers should be fully informed of their rights under this regulation in formats which are accessible to everybody , so that they can effectively exercise those rights . rights of passengers should include the receipt of information regarding the passenger service or cruise before and during the journey . all essential information provided to passengers should also be provided in formats accessible to disabled persons and persons with reduced mobility .


### on passenger services where the port of embarkation is situated outside the territory of a member state and the port of disembarkation is situated in the territory of a member state , provided that the service is operated by a union carrier ; ### on passenger services where the port of embarkation is situated outside the territory of a member state and the port of disembarkation is situated in the territory of a member state , provided that the service is operated by a union carrier as defined by article 3 ;


### on ships certified to carry up to 36 passengers ; ### on sea or inland waterway ships certified to carry up to 36 passengers ;


### under the same conditions set out in paragraph 1 , carriers , travel agents and tour operators may require that a disabled person or person with reduced mobility be accompanied by another person who is capable of providing the assistance required by the disabled person or person with reduced mobility . as regards passenger services , such an accompanying person shall be carried free of charge . ### under the same conditions set out in paragraph 1 , carriers , travel agents and tour operators may require that a disabled person or person with reduced mobility be accompanied by another person who is capable of providing the assistance required by the disabled person or person with reduced mobility . as regards passenger services , such an accompanying person shall be carried free of charge and shall not be deemed to be an agent or to be working for the carrier .


### at a time stipulated in writing by the carrier which shall be not&#160 ; more&#160 ; than 60&#160 ; minutes before the published embarkation time , or ### at a time stipulated in writing by the carrier &#8211 ; including under the access conditions set out in article 9 &#8211 ; which shall be not&#160 ; more&#160 ; than 60&#160 ; minutes before the published embarkation time , or


### the payment of the reimbursement provided for in paragraphs 1 and 2 shall be made within seven days , in cash , by electronic bank transfer , bank order or bank cheque of the full cost of the ticket at the price at which it was purchased , for the part or parts of the journey not made , and for the part or parts already made if the journey no longer serves any purpose in relation to the passenger ' s original travel plan . ### the payment of the reimbursement provided for in paragraphs 1 and 2 shall be made within seven days , in cash , by electronic bank transfer , bank order or bank cheque of the full cost of the ticket at the price at which it was purchased , for the part or parts of the journey not made , and for the part or parts already made if the journey no longer serves any purpose in relation to the passenger ' s original travel plan . if the passenger agrees , the full reimbursement may also be paid in the form of vouchers and / or other services in an amount equivalent to the price for which the ticket was purchased , provided the conditions are flexible , particularly regarding its period of validity and the destination .


### article 17 shall not apply where the cancellation or delay is caused by weather conditions endangering the safe operation of the ship . ### article 17 shall not apply where the cancellation or delay is caused by weather conditions endangering the safe operation of the ship or by extraordinary circumstances .


### carriers and terminal operators shall , within their respective areas of competence , provide passengers with adequate information throughout their travel in accessible formats and in the same languages as those in which information is generally made available to all passengers . particular attention shall be paid to the needs of disabled persons and persons with reduced mobility . ### carriers and terminal operators shall , within their respective areas of competence , provide passengers with adequate information throughout their travel in formats which are accessible to everybody and in the same languages as those in which information is generally made available to all passengers . particular attention shall be paid to the needs of disabled persons and persons with reduced mobility .


### if a passenger covered by this regulation wants to make a complaint to the carrier , he shall submit it within two months from the date on which the service was performed or when a service should have been performed . within one month of receiving the complaint , the carrier shall give notice to the passenger that his complaint has been substantiated , rejected or is still being considered . the time taken to provide the final reply shall not be longer than three months from the receipt of a complaint . ### if a passenger wants to make a complaint to the carrier concerning the rights and obligations covered by this regulation , he shall submit it within two months from the date on which the service was performed or when a service should have been performed . within one month of receiving the complaint , the carrier shall give notice to the passenger that his complaint has been substantiated , rejected or is still being considered . the time taken to provide the final reply shall not be longer than three months from the receipt of a complaint .


### the common set of rules and procedures should be consistent with the financial rules applicable to the annual budget of the union laid down in a regulation of the european parliament and of the council , hereinafter referred to as ' the financial regulation ' , such reference being made in all instances to the latest version of that regulation in force , and including the corresponding rules adopted by the commission for implementing the financial regulation . ### the common set of rules and procedures should be consistent with the financial rules applicable to the annual budget of the union laid down in a regulation of the european parliament and of the council , hereinafter referred to as ' the financial regulation ' , and including the corresponding rules adopted by the commission for implementing the financial regulation .


### the commission shall ensure that actions are implemented in accordance with the objectives of the applicable instrument , and in conformity with an effective protection of the financial interests of the union . the financial assistance provided on the basis of the instruments shall be consistent with the rules and procedures laid down in the financial regulation , which provides the basic financial and legal framework for their implementation . ### the commission shall ensure that actions are effectively and efficiently implemented in accordance with the objectives of the applicable instrument , and in conformity with an effective protection of the financial interests of the union . the financial assistance provided on the basis of the instruments shall be consistent with the rules and procedures laid down in the financial regulation , which provides the basic financial and legal framework for their implementation .


### exceptionally , in particular where an action programme has not yet been adopted , the commission may , on the basis of the indicative programming documents , adopt individual measures under the same rules and procedures as for action programmes . ### exceptionally , where an action programme has not yet been adopted , the commission may , on the basis of the indicative programming documents , adopt individual measures under the same rules and procedures as for action programmes .


### that procedure shall not be required for action programmes and measures below the above - mentioned thresholds , and for non substantial amendments thereto . non - substantial amendments are technical adjustments such as extending the implementation period , reassigning funds within the forecast budget , or increasing or reducing the size of the budget by less than 20% of the initial budget , provided these amendments do not substantially affect the objectives of the initial action programme or measure . in such case , action programmes and measures and non - substantial amendments thereto shall be communicated to the european parliament and to the council within one month of their adoption . ### that procedure shall not be required for action programmes and measures below the above - mentioned thresholds , and for non substantial amendments thereto . non - substantial amendments are technical adjustments such as extending the implementation period , reassigning funds within the forecast budget , or increasing or reducing the size of the budget by less than 10% of the initial budget , provided these amendments do not substantially affect the objectives of the initial action programme or measure . in such case , action programmes and measures and non - substantial amendments thereto shall be communicated to the european parliament and to the council within one month of their adoption .


### appropriate environmental screening , including for climate change and biodiversity impacts , shall be undertaken at project level including where applicable environmental impact assessment for environmentally sensitive projects , in particular for major new infrastructure . where relevant , strategic environmental assessments shall be used in the implementation of sectoral programmes . the involvement of interested stakeholders in environmental assessments and public access to the results shall be ensured . ### appropriate environmental screening shall be undertaken at project level including where applicable environmental impact assessment for environmentally sensitive projects , in particular for major new infrastructure . where relevant , strategic environmental assessments shall be used in the implementation of sectoral programmes . the involvement of all major stakeholders in environmental assessments and public access to the results shall be ensured .


### the union ' s financial assistance may be provided , inter alia , through the following types of financing envisaged by the financial regulation : ### the union ' s financial assistance may be provided through the following types of financing envisaged by the financial regulation :


### in the case of parallel co - financing , an action is split into a number of clearly identifiable components which are each financed by the different partners providing co - financing in such a way that the end - use of the financing can always be identified . ### in the case of parallel co - financing , an action shall be split into a number of clearly identifiable components which are each financed by the different partners providing co - financing in such a way that the end - use of the financing can always be identified .


### in the case of joint co - financing , the total cost of an action is shared between the partners providing the co - financing and the resources are pooled in such a way that it is no longer possible to identify the source of financing for any given activity undertaken as part of the action . ### in the case of joint co - financing , the total cost of an action shall be shared between the partners providing the co - financing and the resources are pooled in such a way that it is no longer possible to identify the source of financing for any given activity undertaken as part of the action .


### the commission shall send its evaluation reports to the european parliament and to the council for information . member states may request to discuss specific evaluations in the committees referred to in article 15 . the results shall feed back into programme design and resource allocation . ### the commission shall send its evaluation reports to the european parliament and to the council for information . the results shall feed back into programme design and resource allocation .


### the commission shall associate to an appropriate extent all relevant stakeholders in the evaluation phase of the union assistance provided under this regulation . ### the commission shall associate all major stakeholders in the evaluation phase of the union assistance provided under this regulation .


### biennal report ### annual report


### the commission shall examine the progress made in implementing the measures of financial assistance taken in external action and shall submit to the european parliament and to the council a report every two years starting in 2016 on the implementation and results and , as far as possible , on the main outcomes and impacts of the union ' s financial assistance . this report shall also be submitted to the european economic and social committee and to the committee of the regions . ### the commission shall examine the progress made in implementing the measures of financial assistance taken in external action and shall submit to the european parliament and to the council a report every year on the implementation and results and , as far as possible , on the main outcomes and impacts of the union ' s financial assistance . this report shall also be submitted to the european economic and social committee and to the committee of the regions .


### the biennal report shall contain information relating to the previous year on the measures financed , the results of monitoring and evaluation exercises , the involvement of the relevant partners , and the implementation of budgetary commitments and of payments appropriations . it shall assess the results of the union ' s financial assistance , using as far as possible , specific and measurable indicators of its role in meeting the objectives of the instruments . ### the annual report shall contain information relating to the previous year on the measures financed , the results of monitoring and evaluation exercises , the involvement of the relevant partners , and the implementation of budgetary commitments and of payments appropriations . it shall assess the results of the union ' s financial assistance , using as far as possible , specific and measurable indicators of its role in meeting the objectives of the instruments .


### the funding allocated in the context of the instruments shall be subject to an annual tracking system based on the oecd methodology , integrated into the existing methodology for performance management of eu programmes , to quantify the expenditure related to climate action and biodiversity at the level of the action programmes , individual and special measures referred to in article 2 , and recorded within evaluations and biennal reports . an annual estimate of the overall spending related to climate action and biodiversity shall be made on the basis of the adopted indicative programming documents . ### the funding allocated in the context of the instruments shall be subject to an annual tracking system based on the oecd methodology , integrated into the existing methodology for performance management of eu programmes , to quantify the expenditure related to climate action and biodiversity at the level of the action programmes , individual and special measures referred to in article 2 , and recorded within evaluations and annual reports . an annual estimate of the overall spending related to climate action and biodiversity shall be made on the basis of the adopted indicative programming documents .


### no later than 31 december 2017 , a report shall be established by the commission on the achievement of the objectives of each of the instruments by means of result and impact indicators measuring the efficiency of the use of resources and the european added value of the instruments , in view of a decision on the renewal , modification or suspension of the types of actions implemented under the instruments . the report shall , in addition , address the scope for simplification , internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities for smart , sustainable and inclusive growth . it shall take into account any findings and conclusions on the long - term impact of the instruments . ### no later than 30 june 2017 , a report shall be established by the commission on the achievement of the objectives of each of the instruments by means of result and impact indicators measuring the efficiency of the use of resources and the european added value of the instruments , in view of a decision on the renewal , modification or suspension of the types of actions implemented under the instruments . the report shall , in addition , address the scope for simplification , internal and external coherence , the continued relevance of all objectives , as well as the contribution of the measures to the union priorities for smart , sustainable and inclusive growth . it shall take into account any findings and conclusions on the long - term impact of the instruments .


### this regulation shall enter into force on the third day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the third day following that of its publication in the official journal of the european union . it shall apply from 1 january 2014 to 31 december 2020 .


### where pasture or agricultural land previously destined for food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production in elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emission . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing land . ### where pasture or agricultural land previously destined for food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production in elsewhere . in the former case , the excess market outlet created by biofuel producers may result in higher yields , as acknowledged by the ifpri report1 and the impact assessment of the commission2 . biofuels produced from biomass which is a result of higher yield do not require additional land and therefore have no indirect land - use change effects . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emission . ________________________ 1 international food policy reseach institute : assessing the land use change consequences of european biofuel policies . final report , october 2011 ________________________ 2 european commission : impact assessment - accompanying the document proposal for a directive of the european parliament and the council amending directive 98 / 70 / ec and directive 2009 / 28 / ec . swd 343 final .