### with a view to ensuring an effective access to the examination procedure , officials who first come into contact with persons seeking international protection , in particular those carrying out surveillance of land or maritime borders or conducting border checks , should receive instructions and necessary training on how to recognise and deal with requests for international protection . they should be able to provide third country nationals or stateless persons who are present in the territory , including at the border , in the territorial waters or in the transit zones of the member states , and wish to request international protection , with all relevant information as to where and how applications for international protection may be lodged . where those persons are present in the territorial waters of a member state , they should be disembarked in land and have their applications examined in accordance with this directive . ### with a view to ensuring an effective access to the examination procedure , officials who first come into contact with persons seeking international protection , in particular those carrying out surveillance of land or maritime borders or conducting border checks , should receive instructions and necessary training on how to recognise , register and forward to the competent determining authority requests for international protection . they should be able to provide third country nationals or stateless persons who are present in the territory , including at the border , in the territorial waters or in the transit zones of the member states , and wish to request international protection , with all relevant information as to where and how applications for international protection may be lodged . where those persons are present in the territorial waters of a member state , they should be disembarked in land and have their applications examined in accordance with this directive .


### in addition , special procedural guarantees for vulnerable applicants , such as minors , unaccompanied minors , persons who have been subjected to torture , rape or other serious acts of violence or disabled persons , should be laid down in order to create the conditions necessary for their effective access to procedures and presenting the elements needed to substantiate the application for international protection . ### in addition , special procedural guarantees for vulnerable applicants , such as minors , unaccompanied minors , persons who have been subjected to torture , rape or other serious acts of violence , such as violence based on gender and harmful traditional practices , or disabled persons , should be laid down in order to create the conditions necessary for their effective access to procedures and presenting the elements needed to substantiate the application for international protection .


### member states should examine all applications on the substance , i . e . assess whether the applicant in question qualifies for international protection in accordance with directive [ … / . . / ec ] [ the qualification directive ] except where the present directive provides otherwise , in particular where it can be reasonably assumed that another country would do the examination or provide sufficient protection . in particular , member states should not be obliged to assess the substance of an application for international protection where a first country of asylum has granted the applicant refugee status or otherwise sufficient protection and the applicant will be readmitted to this country . ### member states should examine all applications on the substance , i . e . assess whether the applicant in question qualifies for international protection in accordance with directive [ … / . . / ec ] [ the qualification directive ] except where the present directive provides otherwise , in particular where it can be reasonably assumed that another country would do the examination or provide effective protection . in particular , member states should not be obliged to assess the substance of an application for international protection where a first country of asylum has granted the applicant refugee status or otherwise effective protection and the applicant will be readmitted to this country . member states should proceed in this way only in cases where the applicant in question is in safety in the third country concerned .


### ' applicant with special needs ' means an applicant who due to age , gender , disability , mental health problems or consequences of torture , rape or other serious forms of psychological , physical or sexual violence is in need of special guarantees in order to benefit from the rights and comply with the obligations in accordance with this directive ; ### ' applicant with special needs ' means an applicant who due to age , gender , sexual orientation , gender identity , disability , mental health problems or consequences of torture , rape or other serious forms of psychological , physical or sexual violence is in need of special guarantees in order to benefit from the rights and comply with the obligations in accordance with this directive ;


### member states shall ensure that a person who wishes to make an application for international protection has an effective opportunity to lodge the application with the competent authority as soon as possible . ### member states shall ensure that a person who wishes to make an application for international protection has an effective opportunity to lodge the application with the competent authority as soon as possible . when applicants are unable to lodge their application in person , member states shall ensure that a legal representative can lodge the application on their behalf .


### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned . ### paragraph 3 shall not apply to cases where disclosure of particular circumstances of a person to members of his / her family can jeopardize the interests of that person , including cases involving gender , sexual orientation , gender identity and / or age based persecution . in such cases , a separate decision shall be issued to the person concerned .


### before a decision is taken by the determining authority , the applicant shall be given the opportunity of a personal interview on his / her application for international protection&#160 ; with a person competent under national law to conduct such an interview . interviews on the substance of an application for international protection shall always be conducted by the personnel of the determining authority . ### before a decision is taken by the determining authority , the applicant shall be given the opportunity of a personal interview on his / her application for international protection&#160 ; with a person competent under national law to conduct such an interview . interviews on the admissibility of an application for international protection and on the substance of an application for international protection shall always be conducted by the personnel of the determining authority .


### member states may determine in national legislation the cases in which a minor shall be given the opportunity of a personal interview . ### member states shall determine in national legislation the cases in which a minor shall be given the opportunity of a personal interview , taking due account of the child’s best interests and special needs .


### ensure that the person who conducts the interview is competent to take account of the personal or general circumstances surrounding the application , including the applicant ' s cultural origin , gender , &#160 ; or vulnerability ; ### ensure that the member of staff of the determining authority who conducts the interview is competent to take account of the personal and general circumstances surrounding the application , including the applicant ' s cultural origin , gender , &#160 ; sexual orientation , gender identity or vulnerability ;


### select a competent interpreter who is able to ensure appropriate communication between the applicant and the person who conducts the interview . the communication need not necessarily take place in the language preferred by the applicant if there is another language which he / she understands and in which he / she is able to communicate clearly . wherever possible , member states shall provide an interpreter of the same sex if the applicant so requests ; ### select a competent interpreter who is able to ensure appropriate communication between the applicant and the person who conducts the interview and is required to comply with a code of conduct laying down the rights and duties of the interpreter . the communication need not necessarily take place in the language preferred by the applicant if there is another language which he / she understands and in which he / she is able to communicate clearly . wherever possible , member states shall provide an interpreter of the same sex if the applicant so requests ;


### the decision to reject an application for international protection from an unaccompanied minor who refused to undergo this medical examination shall not be based solely on that refusal . ### the decision to reject an application for international protection from an unaccompanied minor who refused to undergo this medical examination shall not be based on that refusal .


### insofar as member states provide for the possibility of explicit withdrawal of the application under national law , when an applicant explicitly withdraws his / her application for international protection , member states shall ensure that the determining authority takes a decision to either discontinue the examination or reject the application . ### insofar as member states provide for the possibility of explicit withdrawal of the application under national law , when an applicant explicitly withdraws his / her application for international protection , member states shall ensure that the determining authority takes a decision to discontinue the examination .


### obtain any information from the alleged actor of persecution or serious harm in a manner that would result in such actor being directly informed of the fact that an application has been made by the applicant in question , and would jeopardise the physical integrity of the applicant and his / her dependants , or the liberty and security of his / her family members still living in the country of origin . ### obtain any information from the alleged actor of persecution or serious harm in a manner that would result in such actor being informed of the fact that an application has been made by the applicant in question , and would jeopardise the physical integrity of the applicant and his / her dependants , or the liberty and security of his / her family members still living in the country of origin .


### the consequences of failure to adopt a decision within the time limits provided for in paragraph 3 shall be determined in accordance with national law . ### at the end of the period referred to in paragraph 3 , in the event of failure to adopt a decision , the burden of proof for challenging the granting of protection to an applicant shall lie with the determining authority .


### without prejudice to article 23 , member states shall only consider an application for international protection as unfounded if the determining authority has established that the applicant does not qualify for international protection pursuant to directive [ … . / . . / ec ] [ the qualification directive ] . ### member states shall only consider an application for international protection as unfounded if the determining authority has established that the applicant does not qualify for international protection pursuant to directive [ … . / . . / ec ] [ the qualification directive ] .


### member states shall allow applicants to present their views with regard to the application of the grounds referred to in article 29 in their particular circumstances before a decision to consider an application inadmissible is taken . to that end , member states shall conduct a personal interview on the admissibility of the application . member states may make an exception only in accordance with article 36 in cases of subsequent applications . ### member states shall allow applicants to present their views with regard to the application of the grounds referred to in article 29 in their particular circumstances before a decision to consider an application inadmissible is taken . to that end , the determining authority shall conduct a personal interview on the admissibility of the application . member states may make an exception only in accordance with article 36 in cases of subsequent applications .


### where a person who has applied for international protection&#160 ; in a member state makes further representations or a subsequent application in the same member state , that member state shall&#160 ; examine these further representations or the elements of the subsequent application in the framework of the examination of the previous application or in the framework of the examination of the decision under review or appeal , insofar as the competent authorities can take into account and consider all the elements underlying the further representations or subsequent application within this framework . ### where a person who has applied for international protection&#160 ; in a member state makes further representations or a subsequent application in the same member state , that member state shall&#160 ; examine these further representations or the elements of the subsequent application in the framework of the examination of the previous application or in the framework of the examination of the decision under review or appeal , insofar as the determining authority can take into account and consider all the elements underlying the further representations or subsequent application within this framework .


### the admissibility of an&#160 ; application made at such locations ; and / or ### the admissibility of an&#160 ; application , within the meaning of article 29 , made at such locations ; and / or


### member states shall ensure that a decision in the framework of the procedures provided for in paragraph 1 is taken within a reasonable time . when a decision has not been taken within four weeks , the applicant shall be granted entry to the territory of the member state in order for his / her application to be processed in accordance with the other provisions of this directive . ### member states shall ensure that a decision in the framework of the procedures provided for in paragraph 1 is taken within a reasonable time . when a decision has not been taken within four weeks , the applicant shall be granted entry to the territory of the member state in order for his / her application to be processed in accordance with the other provisions of this directive . the holding of applicants at member states’ borders or transit zones is equivalent to placing them in detention , as referred to in article 22 .


### member states shall provide for reasonable time - limits and other necessary rules for the applicant to exercise his / her right to an effective remedy pursuant to paragraph 1 . ### member states shall provide for minimum time - limits and other necessary rules for the applicant to exercise his / her right to an effective remedy pursuant to paragraph 1 .


### the time limits shall not render impossible or excessively difficult the access of applicants to an effective remedy pursuant to paragraph 1 . member states may also provide for an ex officio review of decisions taken pursuant to article 37 . ### the member states shall set a minimum time limit of forty - five working days during which applicants may exercise their right to an effective remedy ; for applicants under the accelerated procedure referred to in article 27 , the member states shall lay down a minimum time limit of thirty working days . the time limits shall not render impossible or excessively difficult the access of applicants to an effective remedy pursuant to paragraph 1 . member states may also provide for an ex officio review of decisions taken pursuant to article 37 .


### ‘ accessory to an in vitro diagnostic medical device’ means an article which , whilst not being an in vitro diagnostic medical device , is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device to specifically enable or assist the in vitro diagnostic medical device to be used in accordance with its / their intended purpose ; ### ' accessory to an in vitro diagnostic medical device ' means an article which , whilst not being an in vitro diagnostic medical device , is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device to specifically enable the in vitro diagnostic medical device to be used in accordance with its / their intended purpose or to specifically assist the medical functionality of the in vitro diagnostic medical device in view of its / their intended purpose ;


### ‘ clinical evidence’ means the information that supports the scientific validity and performance for the use of a device as intended by the manufacturer ; ### ' clinical evidence ' means the data , positive and negative , supporting the evaluation of the scientific validity and performance for the use of a device as intended by the manufacturer ;


### ‘ performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer . it consists of the analytical and , where applicable , the clinical performance supporting the intended purpose of the device ; ### ' performance of a device ' means the ability of a device to achieve its intended purpose as claimed by the manufacturer . it consists of attainment of technical capabilities , analytical performance and , where applicable , the clinical performance supporting the intended purpose of the device ;


### ‘ performance evaluation’ means the assessment and analysis of data to establish or verify the analytical and , where applicable , the clinical performance of a device ; ### ' performance evaluation ' means the assessment and analysis of data to establish or verify that the device performs as intended by the manufacturer , including the technical , analytical and , where applicable , the clinical performance of a device ;


### proportionate to the risk class and the type of device , manufacturers of devices shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service , and to apply any necessary corrective action , hereinafter referred to as ‘ post - market surveillance plan’ . the post - market surveillance plan shall set out the process for collecting , recording and investigating complaints and reports from healthcare professionals , patients or users on suspected incidents related to a device , keeping a register of non - conforming products and product recalls or withdrawals , and if deemed appropriate due to the nature of the device , sample testing of marketed devices . part of the post - market surveillance plan shall be a plan for post - market follow - up in accordance with part b of annex xii . where post - market follow - up is not deemed necessary , this shall be duly justified and documented in the post - market surveillance plan . ### proportionate to the risk class and the type of device , manufacturers of devices shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service , and to apply any necessary corrective action , hereinafter referred to as ' post - market surveillance plan ' . the post - market surveillance plan shall set out the process for collecting , recording , communicating to the electronic system on vigilance referred in article 60 and investigating complaints and reports from healthcare professionals , patients or users on suspected incidents related to a device , keeping a register of non - conforming products and product recalls or withdrawals , and if deemed appropriate due to the nature of the device , sample testing of marketed devices . part of the post - market surveillance plan shall be a plan for post - market follow - up in accordance with part b of annex xii . where post - market follow - up is not deemed necessary , this shall be duly justified and documented in the post - market surveillance plan and subject to approval by the competent authority .


### the legitimate interest in protecting commercially sensitive information ; ### the legitimate interest in protecting commercially sensitive information , to the extent that it does not undermine public health protection ;


### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body . ### in the case of devices classified as class c and d , other than devices for performance evaluation , the manufacturer shall draw up a summary of safety and performance . it shall be written in a way that is clear to the intended user . this summary shall be accompanied by the dataset collected during the clinical investigation and the post - market clinical follow - up . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 40 and shall be validated by that body .


### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . ### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . based on this exchange of information and on best practices established across member states , the commission shall define , within 2 years of the entry into force of this regulation , guidelines for the procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies to be carried out by national authorities concerned .


### the commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in annex vi or the obligations to which it is subject . it may also commence such investigations on its own initiative . ### the commission shall investigate all cases where concerns have been brought to its attention regarding the continued fulfilment by a notified body of the requirements set out in annex vi or the obligations to which it is subject . it may also commence such investigations on its own initiative , including the unannounced inspection of the notified body by a joint assessment team whose composition meets the conditions set out in article 30 .


### the commission may , by means of implementing acts , specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies , for any of the following aspects : ### the commission shall , by means of implementing acts , specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies , for any of the following aspects :


### where demonstration of conformity with the general safety and performance requirements based on clinical performance data or parts thereof is not deemed appropriate , adequate justification for any such exception shall be given based on the results of the manufacturer ' s risk management and on consideration of the characteristics of the device and , in particular , its intended purpose , the intended performance and the claims of the manufacturer . the adequacy of demonstration of conformity with the general safety and performance requirements based on the results of analytical performance evaluation alone shall be duly substantiated in the technical documentation referred to in annex ii . ### where demonstration of conformity with the general safety and performance requirements based on clinical performance data or parts thereof is not deemed appropriate , adequate justification for any such exception shall be given based on the results of the manufacturer ' s risk management and on consideration of the characteristics of the device and , in particular , its intended purpose , the intended performance and the claims of the manufacturer . the adequacy of demonstration of conformity with the general safety and performance requirements based on the results of analytical performance evaluation alone shall be duly substantiated in the technical documentation referred to in annex ii . exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority .


### the scientific validity data , the analytical performance data and , where applicable , the clinical performance data shall be summarised as part of a clinical evidence report referred to in section 3 of part a of annex xii . the clinical evidence report shall be included or fully referenced in the technical documentation referred to in annex ii relating to the device concerned . ### the scientific validity data , the analytical performance data and , where applicable , the clinical performance data shall be summarised as part of a clinical evidence report referred to in section 3 of part a of annex xii . the clinical evidence report shall be included in the technical documentation referred to in annex ii relating to the device concerned and be made accessible to the public through the electronic system referred to in article 51 at the time the device is placed on the market .


### 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 . realization of the clinical performance studies shall be subject to a positive opinion by the responsible ethics committee .


### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . ### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . realization of the clinical performance studies shall be subject to a positive opinion by the responsible ethics committee .


### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ … ] of regulation no [ ref . of future regulation on clinical trials ] . with the exception of the information referred to in article 50 , the information collated and processed in the electronic system shall be accessible only to the member states and to the commission . ### when setting up the electronic system referred in paragraph 1 , the commission shall ensure that it is interoperable with the eu database for clinical trials on medicinal products for human use set up in accordance with article [ . . . ] of regulation no [ ref . of future regulation on clinical trials ] . with the exception of the information referred to in article 50 and in article 51 , and , the information collated and processed in the electronic system shall be accessible only to the member states and to the commission .


### the commission shall be empowered to adopt delegated acts in accordance with article 85 determining which other information regarding clinical performance studies collated and processed in the electronic system shall be publicly accessible to allow interoperability with the eu database for clinical trials on medicinal products for human use set up by regulation no [ ref . of future regulation on clinical trials ] . article 50 and shall apply . ### the commission shall be empowered to adopt delegated acts in accordance with article 85 for determining the technical requirements and parameters to allow interoperability with the eu database for clinical trials on medicinal products for human use set up by regulation no [ ref . of future regulation on clinical trials ] .


### if the sponsor introduces modifications to a clinical performance study that are likely to have a substantial impact on the safety or rights of the subjects or on the robustness or reliability of the clinical data generated by the study , he shall notify the member state concerned of the reasons for and the content of those modifications . the notification shall be accompanied by an updated version of the relevant documentation referred to in annex xiii . ### if the sponsor introduces modifications to a clinical performance study that are likely to have a substantial impact on the safety or rights of the subjects or on the robustness or reliability of the clinical data generated by the study , he shall notify the member state and the ethics committee concerned of the reasons for and the content of those modifications . the notification shall be accompanied by an updated version of the relevant documentation referred to in annex xiii .


### the sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification , unless the member state concerned has notified the sponsor of its refusal based on considerations of public health , patient safety or public policy . ### the sponsor may implement the modifications referred to in paragraph 1 at the earliest 30 days after notification , unless the member state concerned has notified the sponsor of its duly justified refusal .


### where a member state has refused , suspended or terminated a clinical performance study , or has called for a substantial modification or temporary halt of a clinical performance study , or has been notified by the sponsor of the early termination of a clinical performance study on safety grounds , that member state shall communicate its decision and the grounds therefore to all member states and the commission by means of the electronic system referred to in article 51 . ### where a member state has refused , suspended or terminated a clinical performance study , or has called for a substantial modification or temporary halt of a clinical performance study , or has been notified by the sponsor of the early termination of a clinical performance study on safety grounds , that member state shall communicate such facts and its decision and the grounds therefore to all member states and the commission by means of the electronic system referred to in article 51 .


### within one year from the end of the clinical performance study , the sponsor shall submit to the member states concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in section 2 . 3 . 3 of part a of annex xii . where , for scientific reasons , it is not possible to submit the clinical performance study report within one year , it shall be submitted as soon as it is available . in this case , the clinical performance study protocol referred to in section 2 . 3 . 2 of part a of annex xii shall specify when the results of the clinical performance study are going to be submitted , together with an explanation . ### within one year from the end of the clinical performance study , the sponsor shall submit to the member states concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in section 2 . 3 . 3 of part a of annex xii together with all the data collected during the clinical performance study , including negative findings . where , for scientific reasons , it is not possible to submit the clinical performance study report within one year , it shall be submitted as soon as it is available . in this case , the clinical performance study protocol referred to in section 2 . 3 . 2 of part a of annex xii shall specify when the results of the clinical performance study are going to be submitted , together with an explanation .


### in the single application , the sponsor shall propose one of the member states concerned as coordinating member state . if that member state does not wish to be the coordinating member state , it shall agree , within six days of submission of the single application , with another member state concerned that the latter shall be the coordinating member state . if no other member state accepts to be the coordinating member state , the member state proposed by the sponsor shall be the coordinating member state . if another member state than the one proposed by the sponsor becomes coordinating member state , the deadlines referred to in article 49 shall start on the day following the acceptance . ### concerned member states shall agree , within six days of submission of the single application , which member state shall be the coordinating member state . member states and the commission shall agree , in the framework of the attributions of the medical devices coordination group , on clear rules for designating the coordinating member state .


### in the case of a clinical performance study for which the sponsor has used the single application referred to in article 56 , the sponsor shall report any event as referred to in paragraph 2 by means of the electronic system referred to in article 51 . upon receipt , this report shall be transmitted electronically to all member states concerned . ### in the case of a clinical investigation for which the sponsor has used the single application referred to in article 56 , the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in article 51 . upon receipt , this report shall be transmitted electronically to all member states concerned .


### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission and to the notified bodies . ### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission , to the notified bodies and without prejudice to the preservation of intellectual property , to healthcare professionals and the public . the data referred to in points to of article 60 shall not be considered commercially confidential information .


### in case of devices classified as class c or d , the summary of safety and performance , ### in case of devices classified as class c or d , the summary of safety and performance , and the full dataset collected during the clinical study and the post - market clinical follow - up .


### 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 take a periodicity lower than one inspection per year and shall not be disclosed to the manufacturer .


### 2 . 1 . 4 the analytical performance data shall be summarised as part of the clinical evidence report . ### 2 . 1 . 4 the analytical performance full dataset shall accompany the clinical evidence report and may be summarised as part of it .


### 2 . 2 . 5 clinical performance data shall be summarised as part of the clinical evidence report . ### 2 . 2 . 5 clinical performance full dataset shall accompany the clinical evidence report and may be summarised as part of it .


### – for devices classified as class c according to the rules set out in annex vii , the clinical performance study report shall include the method of data analysis , the study conclusion and the relevant details of the study protocol ; ### – for devices classified as class c according to the rules set out in annex vii , the clinical performance study report shall include the method of data analysis , the study conclusion and the relevant details of the study protocol and the full dataset ;


### – for devices classified as class d according to the rules set out in annex vii , the clinical performance study report shall include the method of data analysis , the study conclusion , the relevant details of the study protocol and the individual data points . ### – for devices classified as class d according to the rules set out in annex vii , the clinical performance study report shall include the method of data analysis , the study conclusion , the relevant details of the study protocol and the full dataset .


### every step in the clinical performance study , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects adopted by the 18th world medical assembly in helsinki , finland , in 1964 and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . ### every step in the clinical performance study , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects adopted by the 18th world medical assembly in helsinki , finland , in 1964 and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . conformity with the above principles shall be granted through a favourable opinion of the concerned ethics committee .


### a ‘ clinical performance study report’ , signed by a medical practitioner or any other authorised person responsible , shall contain documented information on the clinical performance study protocol , results and conclusions of the clinical performance study , including negative findings . the results and conclusions shall be transparent , free of bias and clinically relevant . the report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents . the report shall also include as appropriate any protocol amendments or deviations , and data exclusions with the appropriate rationale . ### a ' clinical performance study report ' , signed by a medical practitioner or any other authorised person responsible , shall contain documented information on the clinical performance study protocol , results and conclusions of the clinical performance study , including negative findings . the results and conclusions shall be transparent , free of bias and clinically relevant . the report shall contain sufficient information to enable it to be understood by an independent party without reference to other documents . the report shall also include as appropriate any protocol amendments or deviations , and data exclusions with the appropriate rationale . the report shall be accompanied by the clinical evidence report as described in point 3 . 1 and be accessible to the public with the placing on the market of the device through the electronic system referred to in article 51 .


### 3 the clinical evidence and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer ' s post - market surveillance plan referred to in article 8 which shall include a plan for the device post - market follow - up in accordance with part b of this annex . ### 3 the clinical evidence data and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer ' s post - market surveillance plan referred to in article 8 which shall include a plan for the device post - market follow - up in accordance with part b of this annex . the clinical evidence data and its subsequent updates through post - market follow - up shall be accessible to the public through the electronic systems referred to in art . 51 and art . 60 .


### within the framework of sustainable urban development , it is considered necessary to support integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas and to define a procedure to establish the list of cities covered by such actions and the financial allocation set aside for such actions . ### within the framework of sustainable and inclusive urban development , it is considered necessary to support integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas and to define a procedure to establish the list of cities covered by such actions and the financial allocation set aside for such actions .


### building on the experience and strengths of the integration of measures in the field of sustainable urban development into operational programmes supported by the erdf during the 2007 - 2013 period , a further step should be taken at union level by establishing an urban development platform . ### building on the experience and strengths of the integration of measures in the field of sustainable and inclusive urban development into operational programmes supported by the erdf during the 2007 - 2013 period , a further step should be taken at union level by establishing an urban development platform .


### in order to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level , the erdf should support innovative actions in the field of sustainable urban development . ### in order to identify or test new solutions to issues relating to sustainable and inclusive urban development which are of relevance at union level , the erdf should support innovative actions in the field of sustainable urban development .


### productive investment , which contributes to creating and safeguarding sustainable jobs , through direct aid to investment in small and medium - sized enterprises ; ### productive investment , which contributes to creating and safeguarding sustainable jobs , primarily through direct aid to investment in small and medium - sized enterprises ;


### investments in social , health and educational infrastructure ; ### investments in social , health and educational infrastructure , with an emphasis on the least - developed regions and the most socio - economically vulnerable regions ;


### development of endogenous potential by supporting regional and local development and research and innovation . these measures shall include : ### investments aimed at developing endogenous potential of research and innovation capacity at regional and local level also through the creation of clusters these measures shall include :


### support to public research and innovation bodies and investment in technology and applied research in enterprises ; ### support to public research and innovation bodies and investment in technology and applied research in enterprises ; this includes the creation of top research institutions , for example as part of a corresponding competition under the horizon 2020 programme , and support for all appropriate measures that will make these institutions internationally attractive , including internationally competitive salaries ;


### in more developed regions , the erdf shall not support investments in infrastructure providing basic services to citizens in the areas of environment , transport , and ict . ### in order to reduce internal development disparities , it may also be necessary in more developed regions to invest in infrastructure providing basic services to citizens in the areas of environment , transport , and ict .


### enhancing research and innovation infrastructure and capacities to develop r&amp ; i excellence and promoting centres of competence , in particular those of european interest ; ### enhancing research and innovation capacities to develop r&amp ; i excellence and promoting the setting - up , upgrade and operation and centres of competence , in particular those of european interest , including their necessary enabling infrastructures ;


### promoting business r&i investment , product and service development , technology transfer , social innovation and public service applications , demand stimulation , networking , clusters and open innovation through smart specialisation ; ### promoting business r&i investment , product and service development , technology transfer , spin - offs , start - ups , social innovation and public service applications , eco - innovation , demand stimulation , collaborative r&i projects , networks of excellences , national / regional research facilities and technology centres , competence centres and science parks , graduate and master education , clusters and open innovation through smart specialisation ;


### supporting technological and applied research , pilot lines , early product validation actions , advanced manufacturing capabilities and first production in key enabling technologies and diffusion of general purpose technologies ; ### supporting technological and applied research , pilot lines , early product validation actions , advanced manufacturing capabilities and first production in key enabling technologies and diffusion of general purpose technologies , through cooperation with actors in the world of research and education , technology transfer , applied research , technology development and demonstration facilities , in order to help companies develop more innovative products , processes , marketing and services and diversify the national / regional economy through new high - growth activities ;


### enhancing access to and use and quality of ict : ### in line with the targets of the digital agenda for europe enhancing access to and use and quality of ict through :


### extending broadband deployment and the roll - out of high - speed networks ; ### extending broadband deployment and the roll - out of high - speed networks , and the support for the adoption of future emerging technologies and digital economy network and of open , affordable , viable and future - proof next generation access infrastructures on areas not sufficiently served by private investment , or where the market fails to deliver . the adoption of long - term investment models should be in line with eu guidance on broadband investment and respect of state aid rules . it should strengthen regional innovation and competitiveness , ensure a high level of competition and create a level playing field for all market players . the resulting infrastructure should enable disaggregation of services at end - user level , and the differentiation of services and end - to - end interoperability of networks and independence of operators and service suppliers .


### strengthening ict applications for e - government , e - learning , e - inclusion and e - health ; ### developing and strengthening ict applications for e - government , e - learning , e - inclusion and e - health ;


### strengthening ict applications for e - government , e - learning , e - inclusion and e - health ; ### strengthening ict applications that contribute to meeting future societal challenges and opportunities such as e - learning , e - health , ageing population , reducing carbon emissions , resource - efficiency , education , e - inclusion , e - culture , energy efficiency , integrated ict solutions for ' smart cities ' , consumer information and empowerment and e - government applications with the aim of enhancing innovation , the modernisation of public administrations and access to these services by citizens , including marginalised groups and people with disabilities ;


### promoting entrepreneurship , in particular by facilitating the economic exploitation of new ideas and fostering the creation of new firms ; ### promoting entrepreneurship , in particular by facilitating the economic exploitation of new ideas and research results and fostering the creation of new firms , including business incubators , also through providing the necessary enabling infrastructure ;


### developing new business models for smes , in particular for internationalisation ; ### developing and applying new business models for smes including new value chains and marketing organisation , in particular for internationalisation ;


### promoting energy efficiency and renewable energy use in smes ; ### increasing energy efficiency and renewable energy use in smes ;


### supporting energy efficiency and renewable energy use in public infrastructures and in the housing sector ; ### increasing energy efficiency and renewable energy use in public infrastructures and in the housing sector ;


### supporting energy efficiency and renewable energy use in public infrastructures and in the housing sector ; ### supporting energy efficiency , wider use of energy performance contracting and renewable energy use especially in public infrastructures and in the deep renovation of the housing sector ;


### promoting low - carbon strategies for urban areas ; ### promoting low - carbon strategies and interventions for urban areas , including public lighting systems and smart grids ;


### developing environment - friendly and low - carbon transport systems and promoting sustainable urban mobility ; ### developing environment - friendly and low - carbon transport systems and promoting sustainable urban and interurban mobility ;


### support for social enterprises ; ### support for social economy enterprises and organisations ;


### common indicators , as set out in the annex to this regulation , shall be used where relevant and in accordance with article 24 of regulation no [ … ] / 2012 [ cpr ] . for common indicators , baselines shall be set at zero and cumulative targets shall be set for 2022 . ### common indicators , as set out in the annex to this regulation , shall be used where relevant following consultation with member states and regions and in accordance with article 24 of regulation no [ … ] / 2012 [ cpr ] . for common indicators , baselines shall be set at zero and cumulative targets shall be set for 2022 .


### sustainable urban development ### sustainable and inclusive urban development


### the erdf shall support , within operational programmes , sustainable urban development through strategies setting out integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas . ### the erdf shall support , within operational programmes , sustainable and inclusive urban development through strategies setting out integrated actions to tackle the economic , environmental , climate and social challenges affecting urban areas .


### each member state shall establish in its partnership contract a list of cities where integrated actions for sustainable urban development are to be implemented and an indicative annual allocation for these actions at national level . ### each member state shall establish in its partnership contract a list of cities where integrated actions for sustainable and inclusive urban development are to be implemented and an indicative annual allocation for these actions at national level .


### each member state shall establish in its partnership contract a list of cities where integrated actions for sustainable urban development are to be implemented and an indicative annual allocation for these actions at national level . ### each member state , in cooperation with the regional authorities , shall establish in its partnership contract a list of cities where integrated actions for sustainable urban development are to be implemented and an indicative annual allocation for these actions at national level .


### the commission shall establish , in accordance with article 51 of regulation no [ &#8230 ; ] / 2012 [ cpr ] , an urban development platform to promote capacity - building and networking between cities and exchange of experience on urban policy at union level in areas related to the investment priorities of the erdf and to sustainable urban development . ### the commission shall establish , in accordance with article 51 of regulation no [ &#8230 ; ] / 2012 [ cpr ] , an urban development platform to promote capacity - building and networking between cities and exchange of experience on urban policy at union level in areas related to the investment priorities of the erdf and to sustainable and inclusive urban development .


### the commission shall establish , in accordance with article 51 of regulation no [ &#8230 ; ] / 2012 [ cpr ] , an urban development platform to promote capacity - building and networking between cities and exchange of experience on urban policy at union level in areas related to the investment priorities of the erdf and to sustainable urban development . ### the commission shall establish regularly , in accordance with article 51 of regulation no [ &#8230 ; ] / 2012 [ cpr ] , in cooperation with the committee of the regions and with support from the relevant territorial cooperation programmes , an urban development platform to promote capacity - building and networking as well as political dialogue and exchange of experience on urban policy at union level especially in areas related to the investment priorities of the erdf and to sustainable urban development .


### the commission shall adopt a list of cities to participate in the platform on the basis of the lists established in the partnership contracts , by means of implementing acts . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 14 . ### the commission shall adopt , in conjunction with the member states , a list of conurbations , towns and cities to participate in the platform on the basis of the lists established in the partnership contracts , by means of implementing acts . these implementing acts shall be adopted in accordance with the advisory procedure referred to in article 14 .


### the list shall contain a maximum number of 300 cities , with a maximum number of 20 per member state . cities shall be selected based on the following criteria : ### the list shall contain a maximum number of 1000 cities , with a maximum number of 45 per member state . cities shall be selected based on the following criteria :


### innovative actions in the field of sustainable urban development ### innovative actions in the field of sustainable and inclusive urban development


### at the initiative of the commission , the erdf may support innovative actions in the field of sustainable urban development , subject to a ceiling of 0 , 2% of the total annual erdf allocation . they shall include studies and pilot projects to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level . ### at the initiative of the commission , the erdf may support innovative actions in the field of sustainable and inclusive urban development , subject to a ceiling of 0 , 2% of the total annual erdf allocation . they shall include studies and pilot projects to identify or test new solutions to issues relating to sustainable urban development which are of relevance at union level .


### the power to adopt delegated acts referred to in article 9 shall be conferred on the commission for an indeterminate period of time from 1 january 2014 . ### the power to adopt delegated acts referred to in article 9 shall be conferred on the commission for a period of five years from 1 january 2014 . the commission shall draw up a report in respect of the delegation of power not later than nine months before the expiry of the five - year period . the delegation of power shall be extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period .


### in accordance with their respective responsibilities , the commission and the member states shall ensure coordination among the csf funds , and with other union policies and instruments , including those in the framework of the union ' s external action . ### in accordance with their respective responsibilities , the commission and the member states shall ensure coordination among the csf funds , and with other union policies and instruments , including those in the framework of the union ' s external action . special attention shall be given and , where relevant , resources be allocated for areas in which other union funds explicitly provide for an integrated approach , such as joint funding for integrated projects in the field of environment and climate .


### operations financed by the csf funds shall comply with applicable union and national law . ### operations financed by the csf funds shall comply with applicable union and national law and should not , through their support for strategic long - lasting investments , undermine the strategic long - term coherent application of this legislation .


### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change objectives using the methodology adopted by the commission . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 . ### the member states and the commission shall ensure that environmental protection requirements , resource efficiency , climate change mitigation and adaptation , disaster resilience and risk prevention and management are promoted in the preparation and implementation of partnership contracts and programmes . member states shall provide information on the support for climate change and environmental objectives , including biodiversity and resource efficiency , using the methodology adopted by the commission . the methodology shall also , to the extent possible , assess the negative impacts of csf - fund expenditure on climate change and environmental objectives . the commission shall adopt this methodology by means of an implementing act . the implementing act shall be adopted in accordance with the examination procedure referred to in article 143 .


### the mechanisms at national and regional level that ensure coordination between the csf funds and other union and national funding instruments and with the eib ; ### the mechanisms at national and regional level that ensure coordination between the csf funds and other union and national funding instruments , especially where those provide for a structured cooperation such as the life programme , and with the eib ;


### member states shall set out the detailed actions relating to the fulfilment of ex ante conditionalities , including the timetable for their implementation , in the relevant programmes . ### member states shall set out the detailed actions relating to the fulfilment of ex ante conditionalities , including the timetable for their implementation , in the relevant programmes . with regards to the implementation of plans or strategies under the thematic objectives 4 , 5 and 6 , member states shall consider integrated projects in the field of climate and environment as a potential model for an efficient , coherent and well coordinated implementation .


### progress towards achievement of the union strategy for smart , sustainable and inclusive growth , in particular in respect of the milestones set out for each programme in the performance framework and the support used for climate change objectives ; ### progress towards achievement of the union strategy for smart , sustainable and inclusive growth , in particular in respect of the milestones set out for each programme in the performance framework and the support used for climate change and environmental , including biodiversity and resource efficiency , objectives ;


### the mechanisms that ensure coordination between the funds , the eafrd , the emff and other union and national funding instruments , and with the eib ; ### the mechanisms that ensure coordination between the funds , the eafrd , the emff and other union and national funding instruments , especially where those provide for a structured cooperation such as the life programme , and with the eib ;


### member states shall submit an opinion of the national equality bodies on the measures set out in points and with the proposal for an operational programme under the investment for growth and jobs goal . ### member states shall submit an opinion of the national or , dependent on the level where the operational programme is prepared , regional environmental bodies on the measures set out in point , and an opinion of the national or regional equality bodies on the measures set out in points and with the proposal for an operational programme under the investment for growth and jobs goal .


### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust . ### in a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable , robust and reflect the diversity of the population in terms of age and gender balance .


### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice . those ‘ low - intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval . ### the risk to subject safety in a clinical trial mainly stems from two sources : the investigational medicinal product and the intervention . many clinical trials , however , pose only a minimal additional risk to subject safety compared to normal clinical practice . this is in particular the case where the investigational medicinal product is covered by a marketing authorisation and where the intervention poses only very limited additional risk to the subject compared to the best current proven intervention . those ' low - intervention clinical trials ' are often of crucial importance to assess standard treatments and diagnoses , thereby optimising the use of medicinal products and thus contributing to a high level of public health . they should be subject to less stringent rules , such as shorter deadlines for approval .


### the sponsor should be allowed to withdraw the application for authorisation of a clinical trial . to ensure the reliable functioning of the assessment procedure , however , an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial . it should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application . ### the sponsor should be allowed to withdraw the application for authorisation of a clinical trial . to ensure the reliable functioning of the assessment procedure , however , an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial . it should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application , provided that the new application contains explanations regarding any previous withdrawals .


### in order to increase transparency in the area of clinical trials , clinical trial data submitted in support of a clinical trial application should be based only on clinical trials recorded in a publicly accessible database . ### in order to increase transparency in the area of clinical trials , clinical trial data submitted in support of a clinical trial application should be based only on clinical trials recorded in a publicly and easily accessible database without imposing any cost on the access to the database .


### in order to streamline and facilitate the flow of information between sponsors and member states as well as between member states , the commission should set up and maintain a database , accessed through a portal . ### in order to streamline and facilitate the flow of information between sponsors and member states as well as between member states , the commission should set up and maintain a database , accessed through a portal . the commission and member states should raise awareness among the general public on the existence of the portal .


### in order to obtain an authorisation , the sponsor shall submit an application dossier to the intended member states concerned through the portal referred to in article 77 . ### in order to obtain an authorisation , the sponsor shall submit an application dossier to the intended member states concerned through the portal referred to in article 77 . within six days following submission of the application dossier , member states shall collectively appoint a reporting member state and a co - reporting member state .


### within six days following submission of the application dossier , the proposed reporting member state shall notify the sponsor through the eu portal of the following : ### within six days following appointment of the reporting member state , the reporting member state shall notify the sponsor through the eu portal of the following :


### whether it is the reporting member state or which other member state concerned is the reporting member state ; ### which other member state is the co - reporting member state ;


### where the member state concerned disagrees with the conclusion on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor . ### where the member state concerned disagrees with the conclusion on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor . the reasons for the disagreement must be published through the eu portal .


### where the member state concerned disagrees with the conclusion on the basis of point of the second subparagraph , it shall communicate its disagreement , together with a detailed justification based on scientific and socio - economic arguments , and a summary thereof , through the eu portal to the commission , to all member states , and to the sponsor . ### where the member state concerned disagrees with the conclusion of the reporting member state , it shall communicate its disagreement , through the eu portal to the commission , to all member states , and to the sponsor .


### for the purposes of this article , a ‘ serious breach’ means a breach likely to affect to a significant degree the safety and rights of the subjects or the reliability and robustness of the data generated in the clinical trial . ### for the purposes of this article , a ' serious breach ' means a breach likely to affect to a significant degree the safety , rights and health of the subjects or the reliability and robustness of the data generated in the clinical trial .


### for clinical trials other than low - intervention clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator . ### for clinical trials , the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject . this damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator .


### the measures referred to in paragraph 1 shall be communicated to all member states concerned through the eu portal . ### the measures referred to in paragraph 1 shall be made publicly available on and communicated to all member states concerned through the eu portal .


### draft legislative resolution ### stresses that point 47 of the interinstitutional agreement of 17 may 2006 between the european parliament , the council and the commission on budgetary discipline and sound financial management1 should apply for the extension of the mandate for the european banking authority ; emphasises that any decision of the legislative authority in favour of such an extension shall be without prejudice to the decisions of the budgetary authority in the context of the annual budgetary procedure ; _______________ 1 oj c 139 , 14 . 6 . 2006 , p . 1 .


### draft legislative resolution ### requests the commission to present a financial statement which fully takes into account the result of the legislative agreement between the european parliament and the council to meet the budgetary and staff requirements of the european banking authority , the commission services and possibly of the european central bank ;


### draft legislative resolution ### reminds the host state of the joint statement of the european parliament , the council of the eu and the european commission on decentralised agencies and its annex signed on 19 july 2012 , in particular paragraphs 8 and 9 of the joint statement ;


### in the absence of horizontal community legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursue a further development of a coherent immigration policy , to lower the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member states but not yet long term residents . such provisions are intended to establish a level playing field within the eu , to recognize that such third - country nationals legally working in a member states contribute to the european economy through their work and tax payments and to serve as a safeguard to reduce unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter . ### in the absence of horizontal union legislation , the rights of third - country nationals vary , depending on the member state in which they work and on their nationality . they do not have the same rights as nationals of the member state , or other eu citizens . with a view to pursuing further development of a coherent immigration policy , narrowing the rights gap between eu citizens and third - country nationals legally working and complementing the existing immigration acquis a set of socio - economic and labour - law rights should be laid down in particular in the form of specifying the policy fields where equal treatment with own nationals is provided for third - country workers legally admitted in a member state but not yet long - term residents . such provisions are intended to introduce a minimum level of fairness within the eu , to recognise that such third - country nationals legally working in member states contribute to the european economy through their work and tax payments and to serve as a safeguard to reduce unfair competition between own nationals and third - country nationals resulting from possible exploitation of the latter . without prejudice to the interpretation of the concept of employment relationship in other union legislation , third - country worker , as laid down in article 2 of this directive , should mean any third - country national who has been admitted to the territory of a member state , is legally resident and is allowed to work under national law or in accordance with national practice in that member state .


### third - country nationals covered by directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services as long as they are posted to a member state and third - country nationals entering a member state under commitments contained in an international agreement facilitating the entry and temporary stay of certain categories of trade and investment - related natural persons should not be covered by this directive as they are not considered part of the labour market of that member state . ### third - country nationals who are posted are not covered by this directive . this should not prevent third - country nationals who are legally residing and lawfully employed in a member state and posted to another member state from continuing to enjoy equal treatment with respect to nationals of the member state of origin for the duration of their posting , in respect of those terms and conditions of employment which are not affected by the application of directive 96 / 71 / ec of the european parliament and of the council of 16 december 1996 concerning the posting of workers in the framework of the provision of services1 . 1 oj l 18 , 21 . 1 . 1997 , p . 1 .


### third - country nationals who work in the territory of a member state should enjoy equal treatment as regards social security . branches of social security are defined in the council regulation no 1408 / 71 of 14 june 1971 on the application of social security schemes to employed persons , to self - employed persons and to members of their families moving within the community . council regulation no 859 / 2003 of 14 may 2003 extending the provisions of regulation no 1408 / 71 and regulation no 574 / 72 to nationals of third countries who are not already covered by those provisions solely on the ground of their nationality extends the provisions of regulation no 1408 / 71 to third country nationals who are legally residing in the european union and who are in a cross - border situation . the provisions on equal treatment concerning social security in this directive also apply to persons coming to a member state directly from a third country . nevertheless , this directive should not confer more rights than those already provided in existing community legislation in the field of social security for third - country nationals who have cross - border elements between member states . ### third - country nationals who work in the territory of a member state should enjoy equal treatment as regards social security . branches of social security are defined in regulation no 883 / 2004 of the european parliament and of the council of 29 april 2004 on the coordination of social security systems . the provisions on equal treatment concerning social security in this directive also apply to persons coming to a member state directly from a third country .


### ' third - country worker ' means any third - country national who has been admitted to the territory of a member state and is allowed to work legally in that member state ; ### ' third - country worker ' means , without prejudice to the interpretation of the concept of employment relationship in other union legislation , any third - country national who has been admitted to the territory of a member state , is legally resident and is allowed to work under national law or in accordance with national practice in that member state ;


### covered by directive 96 / 71 / ec as long as they are posted ; ### covered by directive 96 / 71 / ec as long as they are posted and shall not affect the member states’ responsibility for the access and admission of third - country nationals to their labour markets ;


### if the information supporting the application is inadequate , the designated authority shall notify the applicant of the additional information that is required . the period referred to in paragraph 2 shall be suspended until the authorities have received the additional information required . ### if the information supporting the application is inadequate , according to publicly specified criteria , the designated authority shall notify the applicant in writing of the additional information that is required . the period referred to in paragraph 2 shall be suspended until the authorities have received the additional information required .


### reasons shall be given in the written notification for a decision rejecting the application , not granting , not modifying or not renewing , suspending or withdrawing the single permit on the basis of criteria specified in national or community law . ### reasons shall be given in the written notification for a decision rejecting the application , not granting , not modifying or not renewing , suspending or withdrawing the single permit on the basis of objective and verifiable criteria specified in national or union law .


### working conditions , including pay and dismissal as well as health and safety at the workplace ; ### working conditions , including pay and dismissal as well as health and safety at the workplace , working time , leave and disciplinary procedures , taking into account general collective agreements in force ;


### branches of social security , as defined in council regulation no 1408 / 71 of 14 june 1971 on the application of social security schemes to employed persons , to self - employed persons and to members of their families moving within the community . regulation no 859 / 2003 , extending the provisions of regulation no 1408 / 71 and its implementing regulation no 574 / 72 to nationals of third countries who are not already covered by these provisions solely on the ground of their nationality shall apply accordingly ; ### branches of social security , as defined in regulation no 883 / 2004 of the european parliament and of the council ;


### tax benefits ; ### tax benefits , in so far as the worker is deemed to be resident for tax purposes in the member state concerned ;


### access to goods and services and the supply of goods and services made available to the public including procedures for obtaining housing and the assistance afforded by employment offices . ### access to goods and services and the supply of goods and services made available to the public including procedures for obtaining housing and the assistance and advice services afforded by employment offices as provided by national law .


### by restricting the rights conferred under paragraphs 1 in respect to public housing to cases where the third - country national has been staying or who has the right to stay in its territory for at least three years ; ### by imposing restrictions on the full application of the rights conferred under paragraphs 1 in respect to public housing to cases where the third - country national has been staying or who has the right to stay in its territory for less than three years ;


### by restricting the rights conferred under paragraphs 1 to third - country workers who are in employment except for unemployment benefits ; ### by making use of residence criteria if the residence permit is issued for the purposes other than work but the residence permit allows working ;


### having regard to the treaty on the functioning of the european union , and in particular article 43 thereof , ### having regard to the treaty on the functioning of the european union , and in particular articles 43 and 191 thereof ,


### a professional operator becoming aware of the presence of a union quarantine pest in a plant , plant product or other object which is or was under its control should be under an obligation to take all measures that may be appropriate as regards the elimination of the pest , the withdrawal or recall of the plants , plant products or other objects concerned and the information of the competent authority , other persons in the trade chain and the public . ### a professional operator becoming aware of the presence of a union quarantine pest in a plant , plant product or other object which is or was under its control , should be under an obligation to take all measures that may be appropriate as regards the elimination of the pest in a sustainable way , in line with directive 2009 / 128 / ec establishing a framework for community action to achieve the sustainable use of pesticides14a , the withdrawal or recall of the plants , plant products or other objects concerned and the information of the competent authority , other persons in the trade chain and the public . __________________ 14a oj l 309 , 24 . 11 . 2009 , p . 71


### member states should take all necessary measures to eradicate union quarantine pests , when found present in their territories . it is appropriate to set out measures which may be taken by member states in such a case and the principles based on which they are to decide what measures to take . those measures should include the establishment of restricted areas , consisting of an infested zone and a buffer zone . ### member states should take all necessary measures , making use of the principles of sustainable use of pesticides as mentioned in directive 2009 / 128 / ec14b , to eradicate union quarantine pests , when found present in their territories . it is appropriate to set out measures which may be taken by member states and professional operators in such a case and the principles based on which they are to decide what measures to take . to this end , a hierarchy of measures needs to be defined based on the general principles of integrated pest management . those measures should include the establishment of restricted areas , consisting of an infested zone and a buffer zone . __________________ 14boj l 309 , 24 . 11 . 2009 , p . 71


### early detection of the presence of pests is extremely important for timely and effective eradication . member states should therefore conduct surveys for the presence of union quarantine pests in the areas where those pests were not known to be present . in view of the number of union quarantine pests and the time and resources required to carry out those surveys , member states should establish multi - annual survey programmes . ### prevention , protective measures and early detection of the presence of pests is extremely important for timely and effective eradication . member states should therefore conduct surveys for the presence of union quarantine pests in the areas where those pests were not known to be present . in view of the number of union quarantine pests and the time and resources required to carry out those surveys , member states should establish multi - annual survey programmes .


### under certain conditions member states should be allowed to adopt more stringent eradication measures than required by union legislation . ### under certain conditions member states should be allowed to adopt more stringent eradication measures than required by union legislation , as long as they are applied in a sustainable way .


### plant passports should generally be issued by the professional operator . where professional operators do not have the resources to issue plant passports , the possibility should exist that , upon their request , plant passports are issued by the competent authorities . ### plant passports should generally be issued by the competent authorities .


### ‘ treatment’ means a procedure for the killing , inactivation or removal of pests , or for rendering those pests infertile or for their devitalisation . ### ' treatment ' means a procedure for the killing , inactivation or removal of pests , or for rendering those pests infertile or for their devitalisation based on the principle of sustainable use of pesticides .


### where a professional operator becomes aware that a union quarantine pest is present in plants , plant products or other objects which are under its control , it shall , immediately , and after informing and consulting with the competent authority concerned , take the phytosanitary measures necessary to eliminate that pest from the plants , plant products or other objects concerned and from its premises , where applicable , and prevent the spread of that pest . ### where a professional operator becomes aware that a union quarantine pest is present in plants , plant products or other objects which are under its control , it shall , immediately , and after informing and consulting with the competent authority concerned , take the phytosanitary measures necessary to eliminate that pest from the plants , plant products or other objects concerned and from its premises , where applicable , and prevent the spread of that pest . with this aim , the professional operator has to follow a hierarchy of measures for all types of pests in line with integrated pest management principles , making use primarily of non - chemical sustainable agronomic practices and using pesticides as a last resort ; all measures should be taken in accordance with regulation no 1107 / 200923d concerning the placing of plant protection products on the market and directive 2009 / 128 / ec23e establishing a framework for community action to achieve the sustainable use of pesticides in order to ensure the use of methods / practices which have the lowest health and environmental impact . __________________ 23doj l 309 , 24 . 11 . 2009 , p . 1 23eoj l 309 , 24 . 11 . 2009 , p . 71


### where the presence of a union quarantine pest is officially confirmed , the competent authority shall immediately take all necessary measures to eliminate that pest in the area concerned and to prevent its spread out of that area . those measures shall be adopted in accordance with annex iv on measures and principles for the management of the risks of pests . ### where the presence of a union quarantine pest is officially confirmed , the competent authority shall immediately take all necessary measures in line with directive 2009 / 128 / ec23f establishing a framework for community action to achieve the sustainable use of pesticides and regulation no 1107 / 200923g concerning the placing of plant protection products on the market , to eliminate that pest in the area concerned and to prevent its spread out of that area . those measures shall be adopted in accordance with annex iv on measures and principles for the management of the risks of pests . __________________ 23f oj l 309 , 24 . 11 . 2009 , p . 71 23g oj l 309 , 24 . 11 . 2009 , p . 1


### those surveys shall take account of scientific and technical evidence , and any other appropriate information , concerning the presence of the pests concerned . ### those surveys shall take account of scientific and technical evidence , of the preventive agronomic measures taken by professional operators and any other appropriate information , concerning the presence of the pests concerned .


### access of competent authorities to premises of professional operators and of natural persons , where necessary , laboratories , equipment , personnel , external expertise and resources necessary for the rapid and effective eradication or , where appropriate , containment of the priority pest concerned ; ### access of competent authorities to premises of professional operators and of natural persons , where necessary , laboratories , equipment , personnel , external expertise and resources necessary for the rapid , effective and sustainable eradication or , where appropriate , containment of the priority pest concerned in line with directive 2009 / 128 / ec establishing a framework for community action to achieve the sustainable use of pesticides23i ; __________________ 23i oj l 309 , 24 . 11 . 2009 , p . 71


### where the presence of a priority pest is officially confirmed in the territory of a member state pursuant to article 11 , the competent authority shall immediately adopt a plan setting out the measures for the eradication of the pest concerned , as provided for in articles 16 , 17 and 18 , and a time schedule for the application of those measures . that plan is referred to as the ‘ eradication plan . ### where the presence of a priority pest is officially confirmed in the territory of a member state pursuant to article 11 , the competent authority shall immediately adopt a plan in line with the principles of sustainable use of pesticides , as defined in directive 2009 / 128 / ec23j establishing a framework for community action to achieve the sustainable use of pesticides , setting out the measures for the eradication of the pest concerned , as provided for in articles 16 , 17 and 18 , and a time schedule for the application of those measures . that plan is referred to as the ' eradication plan . __________________ 23j oj l 309 , 24 . 11 . 2009 , p . 71


### where the presence of a pest that is not included in the list of union quarantine pests in the territory of a member state is officially confirmed , and the competent authority concerned considers that that pest may fulfil the conditions for inclusion in the list of union quarantine pests , it shall immediately assess whether that pest fulfils the criteria of subsection 1 of section 3 of annex ii . if it concludes that those criteria are fulfilled , it shall immediately take eradication measures in accordance with annex iv on measures and principles for the management of the risks of pests . articles 16 to 19 shall apply . ### where the presence of a pest that is not included in the list of union quarantine pests in the territory of a member state is officially confirmed , and the competent authority concerned considers that that pest may fulfil the conditions for inclusion in the list of union quarantine pests , it shall immediately assess whether that pest fulfils the criteria of subsection 1 of section 3 of annex ii . if it concludes that those criteria are fulfilled , it shall immediately take eradication measures in accordance with annex iv on measures and principles for the management of the risks of pests and in line with the principles governing the sustainable use of pesticides , as defined in directive 2009 / 128 / ec establishing a framework for community action to achieve the sustainable use of pesticides23k . articles 16 to 19 shall apply . __________________ 23k oj l 309 , 24 . 11 . 2009 , p . 71


### where an authorised operator intends to issue a plant passport , it shall identify and monitor the points of its production process , and the points concerning the movement of plants , plant products and other objects by that operator , which are critical as regards compliance with the rules adopted pursuant to article 27 , and , article 29 , and , article 37 , article 41 , article 80 and article 82 , and , where applicable , article 33 , article 50 and article 81 . ### an authorised operator shall identify and monitor the points of its production process , and the points concerning the movement of plants , plant products and other objects by that operator , which are critical as regards compliance with the rules adopted pursuant to article 27 , and , article 29 , and , article 37 , article 41 , article 80 and article 82 , and , where applicable , article 33 , article 50 and article 81 .


### prevention measures taken against the spread of a priority pest , listed pursuant to article 6 of regulation no [ … ] / [ … ] * , against which union measures have been adopted pursuant to article 27 or article 29 of that regulation , where those measures are essential to protect the union territory against further spread of that priority pest . ### prevention measures taken against the spread of a priority pest , listed pursuant to article 6 of regulation no [ … ] / [ … ] * , against which union measures have been adopted pursuant to article 27 or article 29 of that regulation , where those measures are essential to protect the union territory against further spread of that priority pest ; all measures shall be based on annex iii of directive 2009 / 128 / ec31f establishing a framework for community action to achieve the sustainable use of pesticides , ensuring that professional operators apply prevention measures to all types of pests . __________________ 31f oj l 309 , 24 . 11 . 2009 , p . 71


### costs incurred by member states for compensation to the operators referred to in article 2 , and of regulation [ … ] / [ … ] * for the value of the destroyed plants , plant products or other objects subject to the measures referred to in article 16 of that regulation , as regards priority pests , listed pursuant to article 6 of that regulation ; ### costs incurred by member states for compensation to the operators referred to in article 2 , and of regulation [ . . . ] / [ . . . ] * for the value of the destroyed plants , plant products or other objects subject to the measures referred to in article 16 of that regulation , as regards priority pests , listed pursuant to article 6 of that regulation ; to this end the operators are conditioned to have taken all possible precautionary agronomic practices like for example crop rotation and use of biological control methods ; pesticides should be used as a last resort and according to the best available technology in pesticides reduction measures according to annex iii of directive 2009 / 128 / ec31g establishing a framework for community action to achieve the sustainable use of pesticides . __________________ 31g oj l 309 , 24 . 11 . 2009 , p . 71


### the entry , establishment and spread of the pest in the territory in question , or , if present , the part of that territory where it is distributed to a limited extent , shall have unacceptable economic , social and / or environmental impacts for that territory , or the part of that territory where it is distributed to a limited extent , as regards one or more of the following points : ### the entry , establishment and spread of the pest in the territory in question , or , if present , the part of that territory where it is distributed to a limited extent , shall have unacceptable economic , social and environmental impacts for that territory , or the part of that territory where it is distributed to a limited extent , as regards one or more of the following points :


### based on the information available to the member state , the pest has unacceptable economic , social and / or environmental impacts as regards its territory and , to the extent possible for the member state to assess this , the union territory , if it would establish and spread in that territory , as concerns one or several of the areas defined in point of section 1 . ### based on the information available to the member state , the pest has unacceptable economic , social and environmental impacts as regards its territory and , to the extent possible for the member state to assess this , the union territory , if it would establish and spread in that territory , as concerns one or several of the areas defined in point of section 1 .


### based on the information available to the union , the pest has unacceptable economic , social and / or environmental impacts as regards the union territory , if it would establish and spread in that territory , as concerns one or several of the areas defined in point of section 1 . ### based on the information available to the union , the pest has unacceptable economic , social and environmental impacts as regards the union territory , if it would establish and spread in that territory , as concerns one or several of the areas defined in point of section 1 .