### one key aspect is the creation of a central database that should integrate different electronic systems , with the udi as an integral part of it , to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators , certificates , interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies , vigilance and market surveillance . the objectives of the database are to enhance overall transparency , to streamline and facilitate the flow of information between economic operators , notified bodies or sponsors and member states as well as between member states among themselves and with the commission , to avoid multiple reporting requirements and to enhance the coordination between member states . within an internal market , this can be ensured effectively only at union level and the commission should therefore further develop and manage the european databank on medical devices by further developing the databank set up by commission decision 2010 / 227 / eu of 19 april 2010 on the european databank for medical devices . ### one key aspect is the creation of a central database that should integrate different electronic systems , with the udi as an integral part of it , to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators , certificates , interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies , vigilance and market surveillance . the objectives of the database are to enhance overall transparency , to streamline and facilitate the flow of information between economic operators , notified bodies or sponsors and member states as well as between member states among themselves and with the commission , to avoid multiple reporting requirements and to enhance the coordination between member states . the database will also facilitate the traceability of medical equipment donated or exported to countries outside the union . within an internal market , this can be ensured effectively only at union level and the commission should therefore further develop and manage the european databank on medical devices by further developing the databank set up by commission decision 2010 / 227 / eu of 19 april 2010 on the european databank for medical devices .


### one key aspect is the creation of a central database that should integrate different electronic systems , with the udi as an integral part of it , to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators , certificates , interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies , vigilance and market surveillance . the objectives of the database are to enhance overall transparency , to streamline and facilitate the flow of information between economic operators , notified bodies or sponsors and member states as well as between member states among themselves and with the commission , to avoid multiple reporting requirements and to enhance the coordination between member states . within an internal market , this can be ensured effectively only at union level and the commission should therefore further develop and manage the european databank on medical devices by further developing the databank set up by commission decision 2010 / 227 / eu of 19 april 2010 on the european databank for medical devices . ### one key aspect is the creation of a central database that should integrate different electronic systems , with the udi as an integral part of it , to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators , marketing authorisations , certificates , interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies , vigilance and market surveillance . the objectives of the database are to enhance overall transparency , via better access to information for the public and healthcare professionals , to streamline and facilitate the flow of information between economic operators , the agency , notified bodies or sponsors and member states as well as between member states among themselves and with the commission , to avoid multiple reporting requirements and to enhance the coordination between member states . within an internal market , this can be ensured effectively only at union level and the commission should therefore further develop and manage the european databank on medical devices by further developing the databank set up by commission decision 2010 / 227 / eu of 19 april 2010 on the european databank for medical devices .


### eudamed’s electronic systems regarding devices on the market , the relevant economic operators and certificates should enable the public to be adequately informed about devices on the union market . the electronic system on clinical performance studies should serve as tool for the cooperation between member states and for enabling sponsors to submit , on a voluntary basis , a single application for several member states and , in this case , to report serious adverse events . the electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities . the electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities . ### eudamed’s electronic systems regarding devices on the market , the relevant economic operators and certificates should enable the public and healthcare professionals to be adequately informed about devices on the union market . adequate levels of access for the public and healthcare professionals to those parts of eudamed’s electronic systems which provide key information on in vitro diagnostic medical devices that may pose a risk to public health and safety is essential . where such access is limited , it should be possible , upon a reasoned request , to disclose existing information for in vitro diagnostic medical devices , unless the limitation of access is justified on grounds of confidentiality . the electronic system on clinical performance studies should serve as tool for the cooperation between member states and for enabling sponsors to submit , on a voluntary basis , a single application for several member states and , in this case , to report serious adverse events . the electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities . the electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities .


### for high - risk in vitro diagnostic medical devices , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available . ### for high - risk in vitro diagnostic medical devices , manufacturers should provide the national authority or the agency , as relevant , involved in the marketing authorisation procedure , with a full report on the safety and clinical performance aspects of that device . a summary of that report should be publicly available via eudamed .


### sponsors of interventional clinical performance studies and other clinical performance studies involving risks for the subjects to be conducted in more than one member state should be given the possibility to submit a single application in order to reduce administrative burden . in order to allow for resource - sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several member stats , such single application should facilitate the coordination between the member states under the direction of a coordinating member state . the coordinated assessment should not include the assessment of intrinsically national , local and ethical aspects of a clinical performance study , including informed consent . each member state should retain the ultimate responsibility for deciding whether the clinical performance study may be conducted on its territory . ### sponsors of interventional clinical performance studies and other clinical performance studies involving risks for the subjects to be conducted in more than one member state should be given the possibility to submit a single application in order to reduce administrative burden . in order to allow for resource - sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several member stats , such single application should facilitate the coordination between the member states under the direction of a coordinating member state . each member state should retain the ultimate responsibility for deciding whether the clinical performance study may be conducted on its territory .


### in order to better protect health and safety regarding devices on the market , the vigilance system for in vitro diagnostic medical devices should be made more effective by creating a central portal at union level for reporting serious incidents and field safety corrective actions . ### in order to better protect health and safety regarding devices on the market , the vigilance system for in vitro diagnostic medical devices should be made more effective by creating a central portal at union level for reporting serious incidents and field safety corrective actions within and outside the union .


### healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents . ### healthcare professionals and patients should be empowered to report suspected serious incidents which affect the safety of patients , healthcare professionals or other persons , at national level using harmonised formats . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents .


### healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats . the national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents . ### member states should take all necessary measures to raise awareness among healthcare professionals , users and patients about the importance of reporting suspected serious incidents . healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats . in order to minimise the recurrence of such incidents , the national competent authorities should inform manufacturers and report the information via the respective electronic system in eudamed when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents .


### the member states shall levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by member states and to establish a level playing field for notified bodies . ### the member states shall levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by member states and to establish a level playing field for notified bodies . these fees should be comparable across member states and should be made public .


### whilst this regulation should not affect the right of the member states to levy fees for activities at national level , member states should inform the commission and the other member states before they adopt the level and structure of the fees to ensure transparency . ### whilst this regulation should not affect the right of the member states to levy fees for activities at national level , member states should inform the commission and the other member states before they adopt the comparable level and structure of the fees to ensure transparency .


### an expert committee , the medical device coordination group , composed of persons designated by the member states , based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices , should be established in accordance with the conditions and modalities defined in article 78 of regulation [ ref . of future regulation on medical devices ] on medical devices to fulfil the tasks conferred on it by this regulation and by regulation [ ref . of future regulation on medical devices ] on medical devices , to provide advice to the commission and to assist the commission and the member states in ensuring a harmonised implementation of this regulation . ### a medical device coordination group , composed of persons designated by the member states , based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices , should be established in accordance with the conditions and modalities defined in article 78 of regulation [ ref . of future regulation on medical devices ] on medical devices to fulfil the tasks conferred on it by this regulation and by regulation [ ref . of future regulation on medical devices ] on medical devices , to provide advice to the commission and to assist the commission and the member states in ensuring a harmonised implementation of this regulation .


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


### ‘ field safety notice’ means the communication sent by the manufacturer to users or customers in relation to a field safety corrective action ; ### ‘ field safety notice’ means the communication sent by the manufacturer to users , waste disposal operators or customers in relation to a field safety corrective action ;


### chapter ii making available of devices , obligations of economic operators , ce marking , free movement ### chapter vi making available of devices , obligations of economic operators , ce marking , free movement


### chapter iii identification and traceability of devices , registration of devices and of economic operators , summary of safety and performance , european databank on medical devices ### chapter vii identification and traceability of devices , registration of devices and of economic operators , summary of safety and performance , european databank on medical devices


### the national authority responsible for notified bodies shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks . ### the national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel ' in house ' for the proper performance of its tasks . compliance with that requirement shall be assessed in the peer - review referred to in paragraph 8 . in particular , the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3 . 2 . 5 . of annex vi . similarly , the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer’s quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3 . 2 . 6 . of annex vi .


### without prejudice to article 31 , where a national authority is responsible for the designation of notified bodies in the field of products other than in vitro diagnostic medical devices , the competent authority for in vitro diagnostic medical devices shall be consulted on all aspects specifically related to such devices . ### where a national authority is responsible for the designation of notified bodies in the field of products other than in vitro diagnostic medical devices , the competent authority for in vitro diagnostic medical devices shall be consulted on all aspects specifically related to such devices .


### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed authorities , and submit it to the commission . the commission may participate in the review . the outcome of the peer - review shall be communicated to all member states and to the commission and a summary of the outcome shall be made publicly available . ### the member states shall draw up the annual plan for the peer - review , ensuring an appropriate rotation in respect of reviewing and reviewed authorities , and submit it to the commission . the commission shall participate in the review . the outcome of the peer - review shall be communicated to all member states and to the commission and a summary of the outcome shall be made publicly available .


### notified bodies shall satisfy the organisational and general requirements and the quality management , resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this regulation . minimum requirements to be met by notified bodies are set out in annex vi . ### notified bodies shall satisfy the organisational and general requirements and the quality management , resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this regulation . in this respect , permanent ' in house ' administrative , technical and scientific personnel , with pharmacological , medical and technical knowledge is crucial . minimum requirements to be met by notified bodies are set out in annex vi . in particular , in accordance with point 1 . 2 . of annex vi , the notified body shall be organised and operated so as to safeguard the independence , objectivity and impartiality of its activities and avoid conflict of interests .


### where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment , it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in annex vi and shall inform the national authority responsible for notified bodies accordingly . ### notified body shall have permanent ' in house ' competent personnel and expertise , both in technical fields linked with the assessment of the performance of the devices , and in the medical field . they shall have the capacity to evaluate ' in house ' the quality of subcontractors . subcontracting shall be awarded to public entities . contracts can also be awarded to external experts for the assessment of innovative medical devices or technologies where clinical expertise is limited .


### conformity assessment activities may be subcontracted or carried out by a subsidiary only with the agreement of the legal or natural person that applied for conformity assessment . ### conformity assessment activities may be subcontracted or carried out by a subsidiary only with the explicit agreement of the legal or natural person that applied for conformity assessment .


### notified bodies shall keep at the disposal of the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this regulation . ### at least once a year , notified bodies shall submit to the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this regulation .


### findings regarding non - compliance of a body with the requirements set out in annex vi shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application . divergent opinions shall be identified in the assessment report of the national authority responsible . ### findings regarding non - compliance of an applicant conformity assessment body with the requirements set out in annex vi shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team . the national authority shall set out in the assessment report the measures it will take to ensure compliance of that applicant conformity assessment body with the requirements set out in annex vi .


### the joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the commission shall immediately submit this opinion to the mdcg . within 21 days after receipt of the opinion of the joint assessment team , the mdcg shall issue a recommendation with regard to the draft notification which the relevant national authority shall duly take into consideration for its decision on the designation of the notified body . ### the joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the commission shall immediately submit this opinion to the mdcg . within 21 days after receipt of the opinion of the joint assessment team , the mdcg shall issue a recommendation with regard to the draft notification . the relevant national authority shall base its decision on the designation of the notified body on this recommendation by the mdcg . in case where its decision differs from that recommendation , the national authority shall provide the mdcg with all necessary justifications .


### member states may notify only conformity assessment bodies which satisfy the requirements set out in annex vi . ### member states shall notify only conformity assessment bodies which satisfy the requirements set out in annex vi .


### when a member state or the commission raises objections in accordance with paragraph 7 , the effect of the notification shall be suspended . in this case , the commission shall bring the matter before the mdcg within 15 days after expiry of the period referred to in paragraph 7 . after consulting the parties involved , the mdcg shall give its opinion at the latest within 28 days after the matter has been brought before it . if the notifying member state does not agree with the opinion of the mdcg , it may request the commission to give its opinion . ### when a member state or the commission raises objections in accordance with paragraph 7 , the effect of the notification shall be immediately suspended . in this case , the commission shall bring the matter before the mdcg within 15 days after expiry of the period referred to in paragraph 7 . after consulting the parties involved , the mdcg shall give its opinion at the latest within 28 days after the matter has been brought before it . if the notifying member state does not agree with the opinion of the mdcg , it may request the commission to give its opinion .


### the commission shall make accessible to the public the list of the bodies notified under this regulation , including the identification numbers that have been assigned to them and the activities for which they have been notified . the commission shall ensure that the list is kept up to date . ### the commission shall make easily accessible to the public the list of the bodies notified under this regulation , including the identification numbers that have been assigned to them and the activities for which they have been notified . the commission shall ensure that the list is kept up to date .


### notified bodies shall , without delay , inform the national authority responsible for notified bodies of any changes , in particular regarding their personnel , facilities , subsidiaries or subcontractors , which may affect compliance with the requirements set out in annex vi or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated . ### notified bodies shall , without delay , and at least within 15 days , inform the national authority responsible for notified bodies of any changes , in particular regarding their personnel , facilities , subsidiaries or subcontractors , which may affect compliance with the requirements set out in annex vi or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated .


### the national authority responsible for notified bodies shall immediately inform the commission and the other member states of any suspension , restriction or withdrawal of a notification . ### the national authority responsible for notified bodies shall immediately and at least within 10 days , inform the commission and the other member states of any suspension , restriction or withdrawal of a notification .


### the national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to the notification have an impact on the certificates issued by the notified body and , within three months after having notified the changes to the notification , shall submit a report on its findings to the commission and the other member states . where necessary to ensure the safety of devices on the market , that authority shall instruct the notified body to suspend or withdraw , within a reasonable period of time determined by the authority , any certificates which were unduly issued . if the notified body fails to do so within the determined period of time , or has ceased its activity , the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued . ### the national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to the notification have an impact on the certificates issued by the notified body and , within three months after having notified the changes to the notification , shall submit a report on its findings to the commission and the other member states . where necessary to ensure the safety of devices on the market , that authority shall instruct the notified body to suspend or withdraw , within a reasonable period of time determined by the authority , and at the latest 30 days after the publication of the report , any certificates which were unduly issued . if the notified body fails to do so within the determined period of time , or has ceased its activity , the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued .


### the authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately inform the commission , the other member states and the other notified bodies thereof . ### the authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately and at least within 10 days , inform the commission , the other member states and the other notified bodies thereof .


### the commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in article 39 of regulation [ ref . of future regulation on medical devices ] . ### the commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in article 39 of regulation [ ref . of future regulation on medical devices ] . this group shall meet on a regular basis and at least twice a year .


### fees ### fees for the activities of national authorities


### the member state where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies . these fees shall , wholly or partly , cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this regulation . ### the member state where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies . these fees shall , wholly or partly , cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this regulation . these fees shall be comparable across member states and the level of the fees shall be made public .


### section 1 – classification ### chapter ii classification


### in the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in articles 59 to 73 , the commission shall be empowered to adopt delegated acts in accordance with article 85 as regards the following : ### in the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in articles 59 to 73 , the commission , having consulted relevant stakeholders , including healthcare professionals ' organisations , and manufacturers’ associations , shall be empowered to adopt delegated acts in accordance with article 85 as regards the following :


### in addition , where a reference laboratory is designated in accordance with article 78 , the notified body performing the conformity assessment shall request that reference laboratory to verify compliance of the device with the applicable cts , when available , or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent , as specified in section 5 . 4 of annex viii and in section 3 . 5 of annex ix . ### in addition , where a reference laboratory is designated in accordance with article 78 , the committee for the authorisation of in vitro diagnostic medical device referred to in article 39c , or the national authority , shall request that reference laboratory to verify compliance of the device with the applicable cts , when available , or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent , as specified in section 5 . 4 of annex viii and in section 3 . 5 of annex ix .


### involvement of notified bodies ### involvement of notified bodies in the conformity assessment procedure


### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application may not be lodged in parallel with more than one notified body for the same conformity assessment activity . ### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . where a manufacturer applies to a notified body located in a member state other than the one where it is registered , the manufacturer shall inform its national authority responsible for the notified bodies of the application . an application may not be lodged in parallel with more than one notified body for the same conformity assessment activity .


### in cases where a manufacturer terminates his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device , the modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer , the outgoing notified body and the incoming notified body . this agreement shall address at least the following aspects : ### where a manufacturer decides to terminate his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device , it shall inform its national authority responsible for the notified bodies of this change . the modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer , the outgoing notified body and the incoming notified body . this agreement shall address at least the following aspects :


### chapter vi clinical evidence ### chapter v clinical evidence


### to verify that devices achieve the intended benefits to the patient as specified by the manufacturer ; ### to verify the clinical safety and efficacy of the device , including the intended benefits to the patient , when used for the intended purpose , in the target population and in accordance with the instructions of use ;


### 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 , in accordance with article 48 a , and that the clinical data generated in the clinical performance study are going to be reliable and robust .


### where the member state finds that the clinical performance study applied for does not fall within the scope of this regulation or that the application is not complete , it shall inform the sponsor thereof and shall set a maximum of six days for the sponsor to comment or to complete the application . ### where the member state finds that the clinical performance study applied for does not fall within the scope of this regulation or that the application is not complete , it shall inform the sponsor thereof and shall set a maximum of ten days for the sponsor to comment or to complete the application .


### 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 therefor 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 or efficacy grounds , that member state shall communicate its decision and the grounds for that decision to all member states and the commission by means of the electronic system referred to in article 51 .


### if the sponsor has temporarily halted a clinical performance study on safety grounds , he shall inform the member states concerned within 15 days of the temporary halt . ### if the sponsor has temporarily halted a clinical performance study on safety or efficacy grounds , he shall inform the member states concerned within 15 days of the temporary halt .


### the sponsor shall notify each member state concerned of the end of a clinical performance study in relation to that member state , providing a justification in the event of early termination . that notification shall be made within 15 days from the end of the clinical performance study in relation to that member state . ### the sponsor shall notify each member state concerned of the end of a clinical performance study in relation to that member state , providing a justification in the event of early termination , so that all member states can inform sponsors conducting similar clinical performance studies at the same time within the union of the results of that clinical performance study . that notification shall be made within 15 days from the end of the clinical performance study in relation to that member state .


### if the study is conducted in more than one member state , the sponsor shall notify all member states concerned of the overall end of the clinical performance study . that notification shall be made within 15 days from the overall end of the clinical performance study . ### if the study is conducted in more than one member state , the sponsor shall notify all member states concerned of the overall end of the clinical performance study . information on the reasons for the early termination of the clinical performance study shall also be provided to all member states , so that all member states can inform sponsors conducting similar clinical performance studies at the same time within the union of the results of that the clinical performance study . that notification shall be made within 15 days from the overall end of the clinical performance study .


### 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 . ### in the single application , the sponsor shall propose one of the member states concerned as coordinating member state . the reporting member state shall be chosen from among the member states concerned in which most of the subjects participating in the clinical performance study in question live . 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 .


### chapter vii vigilance and market surveillance ### chapter viii vigilance and market surveillance


### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . ### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . member states shall nevertheless maintain other formats for reporting suspected serious incidents to national competent authorities .


### any serious incident in respect of devices made available on the union market ; ### any serious incident , including date and place of incident , in respect of devices made available on the union market ; where available , the manufacturer shall include information on the patient or user and healthcare professional involved in the incident ;


### the member states shall take all appropriate measures to encourage healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up . ### the member states shall take all appropriate measures , including targeted information campaigns , to encourage healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall inform the manufacturer of the device concerned without delay . the manufacturer shall ensure the appropriate follow - up . where a competent authority of a member state ascertains that the reports received pursuant to the first subparagraph relate to a serious incident it shall notify those reports to the electronic system referred to in article 60 without delay , unless the same incident has already been reported by the manufacturer .


### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . ### the commission , in cooperation with the member states and in consultation with relevant partners including patient and consumer organisations , shall develop standard forms for electronic and non - electronic reporting of serious incidents by healthcare professionals , users and patients .


### 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 agency , to the notified bodies and healthcare professionals . .


### the commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system . ### the commission shall ensure that the public has an appropriate level of access to the electronic system . in particular , it shall ensure that , in case information is requested on a specific in vitro diagnostic medical device , it is made available without delay and within 15 days .


### member states shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory , and that is brought to their knowledge in accordance with article 59 is , at national level , evaluated centrally by their competent authority , if possible together with the manufacturer . ### member states shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory , and that is brought to their knowledge in accordance with article 59 is , at national level , evaluated centrally by their competent authority , if possible together with the manufacturer . the competent authority shall take into account the views of all relevant stakeholders , including patient and healthcare professionals ' organisations and manufacturers ' associations .


### the information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the member states and to the commission . ### the information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the member states , to the commission , to the agency and to healthcare professionals . the commission shall also ensure that the public has an appropriate level of access to the electronic system . in particular , it shall ensure that , in case information is requested on a specific in vitro diagnostic medical device , it is made available without delay and within 15 days . .


### chapter viii cooperation between member states , medical device coordination group , eu reference laboratories , device registers ### chapter ix cooperation between member states , medical device coordination group , eu reference laboratories , device registers


### the commission and the member states shall take all appropriate measures to encourage the establishment of registers for specific types of devices to gather post - market experience related to the use of such devices . such registers shall contribute to the independent evaluation of the long - term safety and performance of devices . ### the commission and the member states shall take all appropriate measures to ensure the establishment of registers for in vitro diagnostic devices to gather post - market experience related to the use of such devices . registers for class c and d shall be systematically established . such registers shall contribute to the independent evaluation of the long - term safety and performance of devices .


### this regulation shall be without prejudice to the possibility for member states to levy fees for the activities set out in this regulation , provided that the level of the fees is set in a transparent manner and on the basis of cost recovery principles . they shall inform the commission and the other member states at least three months before the structure and level of fees is to be adopted . ### this regulation shall be without prejudice to the possibility for member states to levy fees for the activities set out in this regulation , provided that the level of the fees is comparable and set in a transparent manner and on the basis of cost recovery principles . they shall inform the commission and the other member states at least three months before the structure and level of fees is to be adopted .


### the member states shall lay down the provisions on penalties applicable for infringement of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them . ### the member states shall lay down the provisions on penalties applicable for infringement of the provisions of this regulation and shall take all measures necessary to ensure that they are implemented . the penalties provided for must be effective , proportionate and dissuasive . the dissuasive nature of the penalty shall be determined in relation to the financial benefit obtained as a result of the infringement . the member states shall notify those provisions to the commission by [ 3 months prior to the date of application of this regulation ] and shall notify it without delay of any subsequent amendment affecting them .


### chapter ix confidentiality , data protection , funding , penalties ### chapter x confidentiality , data protection , funding , penalties


### chapter x final provisions ### chapter xi final provisions


### it shall apply from [ five years after entry into force ] . ### it shall apply from [ three years after entry into force ] .


### the organisational structure and the functions , responsibilities and authority of its top - level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented . ### the organisational structure and the functions , responsibilities and authority of its top - level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented . this information shall be made publicly available .


### 2 . 6 . the notified body shall ensure and document that the activities of its subsidiaries or subcontractors , or of any associated body , do not affect its independence , impartiality or objectivity of its conformity assessment activities . ### 2 . 6 . the notified body shall ensure and document that the activities of its subsidiaries or subcontractors , or of any associated body , do not affect its independence , impartiality or objectivity of its conformity assessment activities . the notified body shall provide evidence to the national authority of its compliance with this point .


### the personnel of a notified body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this regulation , except in relation to the national authorities responsible for notified bodies , competent authorities or the commission . proprietary rights shall be protected . to this end , the notified body shall have documented procedures in place . ### the personnel of a notified body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this regulation , only in justified cases and except in relation to the national authorities responsible for notified bodies , competent authorities or the commission . proprietary rights shall be protected . to this end , the notified body shall have documented procedures in place . where information and data are requested by the public or healthcare professionals , the notified body shall make publicly available the reasons for such information being subject to non - disclosure .


### 6 . 1 . the notified body shall participate in , or ensure that its assessment personnel is informed of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation , guidance and best practice documents adopted in the framework of this regulation . ### 6 . 1 . the notified body shall participate in , or ensure that its assessment personnel is informed of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation , guidance and best practice documents adopted in the framework of this regulation . the notified body shall keep a record of the actions it takes to inform its personnel .


### this presupposes the availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified , having regard to the requirements of this regulation and , in particular , those set out in annex i . ### this presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified , having regard to the requirements of this regulation and , in particular , those set out in annex i .


### 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to in vitro diagnostic medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . ### 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with pharmacological , medical and technical knowledge and sufficient and appropriate experience relating to in vitro diagnostic medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data .


### 2 . 4 . notified bodies shall have available personnel with clinical expertise . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : ### 2 . 4 . clinical experts : notified bodies shall have available , on a permanent basis , personnel with expertise in clinical investigation design , medical statistics , clinical patient management , good clinical practice in the field of clinical performance studies and pharmacology . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to :


### 2 . 5 . the personnel responsible for carrying out product related review shall have the following proven qualification : ### 2 . 5 . product assessors : the personnel responsible for carrying out product related review shall have the following proven qualification :


### 2 . 6 . the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have the following proven qualification : ### 2 . 6 . auditors : the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have the following proven qualification :


### 4 . 2 . where a notified body subcontracts conformity assessment activities either to an organisation or an individual , it shall have a policy describing the conditions under which subcontracting may take place . any subcontracting or consultation of external experts shall be properly documented and be subject to a written agreement covering , among others , confidentiality and conflict of interests . ### 4 . 2 . where a notified body subcontracts conformity assessment activities either to an organisation or an individual , it shall have a policy describing the conditions under which subcontracting may take place . any subcontracting or consultation of external experts shall be properly documented , be publicly available and be subject to a written agreement covering , among others , confidentiality and conflict of interests .


### 5 . 2 . it shall review the competence of its personnel and identify training needs in order to maintain the required level of qualification and knowledge . ### 5 . 2 . it shall review the competence of its personnel and identify training needs and ensure that necessary measures are taken accordingly , in order to maintain the required level of qualification and knowledge .


### 3 . the notified body shall have in place documented procedures covering at least : ### 3 . the notified body shall have in place documented procedures that are publicly available covering at least :


### in the light of article 9 of the united nations convention on the rights of persons with disabilities and in order to give disabled persons and persons with reduced mobility opportunities for maritime and inland waterway travel comparable to those of other citizens , rules for non - discrimination and assistance during their journey should be established . those persons should therefore be accepted for carriage and not refused transport on the grounds of their disability or lack of mobility , except for reasons which are justified on the grounds of health and safety and established by the competent authorities . they should enjoy the right to assistance in ports and on board passenger ships . in the interests of social inclusion , the persons concerned should receive this assistance free of charge . carriers should establish access conditions , preferably using the european standardisation system . ### in the light of article 9 of the united nations convention on the rights of persons with disabilities and in order to give disabled persons and persons with reduced mobility opportunities for maritime and inland waterway travel comparable to those of other citizens , rules for non - discrimination and assistance during their journey should be established . those persons should therefore be accepted for carriage and not refused transport , except for reasons which are justified on the grounds of safety and established by the competent authorities . they should enjoy the right to assistance in ports and on board passenger ships . in the interests of social inclusion , the persons concerned should receive this assistance free of charge . carriers should establish access conditions , preferably using the european standardisation system .


### with the involvement of stakeholders , professional associations and associations of customers , passengers , disabled persons and persons with reduced mobility , carriers should cooperate in order to adopt arrangements at national or european level for improving care and assistance offered to passengers whenever their travel is interrupted , notably in the event of long delays or cancellation of travel . ### with the involvement of stakeholders , professional associations and associations of customers , passengers , disabled persons and persons with reduced mobility , carriers should cooperate in order to adopt arrangements at national or european level for improving care and assistance offered to passengers whenever their travel is interrupted , notably in the event of long delays or cancellation of travel . national enforcement bodies should be informed of these arrangements .


### passengers should be fully informed of their rights under this regulation , so that they can effectively exercise those rights . rights of passengers should include the receipt of information regarding the passenger service or cruise before and during the journey . all essential information provided to passengers should also be provided in formats accessible to disabled persons and persons with reduced mobility . ### passengers should be fully informed of their rights under this regulation , so that they can effectively exercise those rights . rights of passengers should include the receipt of information regarding the passenger service or cruise before and during the journey . this information should be provided according to a common conceptual model for public transport data and systems in order to allow for the provision of integrated information and ticketing . all essential information provided to passengers should also be provided in formats accessible to disabled persons and persons with reduced mobility , with such accessible formats allowing passengers to access the same information using , for example , text , braille , audio , video and / or electronic formats .


### passengers should be able to exercise their rights by means of appropriate complaint procedures implemented by carriers or , as the case may be , by the submission of complaints to the body or bodies designated to that end by the member state . carriers should respond to complaints by passengers within a certain period of time , bearing in mind that the non - reaction to a complaint might be held against them . ### passengers should be able to exercise their rights by means of appropriate and accessible complaint procedures implemented by carriers or , as the case may be , by the submission of complaints to the body or bodies designated to that end by the member state . carriers should respond to complaints by passengers within a set period of time , bearing in mind that the non - reaction to a complaint could be held against them .


### on a cruise where the port of embarkation is situated in the territory of a member state . however , articles 16 , 18 , 19 and 20 and shall not apply to those passengers . ### on a cruise where the port of embarkation or disembarkation is situated in the territory of a member state . however , articles 16 , 18 , 19 and 20 and shall not apply to those passengers .


### member states may exempt from the application of this regulation passenger services covered by public service obligations , public service contracts or integrated services provided that the rights of passengers under this regulation are adequately guaranteed under national law . ### member states may exempt from the application of this regulation passenger services covered by public service obligations , public service contracts or integrated services provided that the rights of passengers under this regulation are comparably guaranteed under national law .


### ' carrier ' means a natural or legal person offering transport by passenger services or cruises to the general public ; ### ' carrier ' means a natural or legal person offering transport by passenger services or cruises to the general public , other than a tour operator , a ticket vendor or a travel agent ;


### ' port terminal ' means a terminal , staffed by a carrier or a terminal operator , in a port with facilities , such as check - in , ticket counters or lounges , and staff for the embarkation or disembarkation of passengers travelling on passenger services or on a cruise ; ### ' port terminal ' means a terminal in a port with facilities , such as check - in , ticket counters or lounges , and staff for the embarkation or disembarkation of passengers travelling on passenger services or on a cruise ;


### ' travel agent ' means any retailer acting on behalf of a passenger for the conclusion of transport contracts ; ### ' travel agent ' means any retailer acting on behalf of a passenger or a tour operator for the conclusion of transport contracts ;


### ' tour operator ' means an organiser , other than a carrier , within the meaning of article 2 and of directive 90 / 314 / eec ; ### ' tour operator ' means an organiser or retailer , other than a carrier , within the meaning of article 2 and of directive 90 / 314 / eec ;


### carriers , travel agents and tour operators shall not refuse to accept a reservation , to issue or otherwise provide a ticket or to embark persons on the grounds of disability or of reduced&#160 ; mobility . ### carriers , travel agents and tour operators shall not refuse to accept a reservation , to issue or otherwise provide a ticket or to embark persons on the grounds of disability or of reduced&#160 ; mobility as such .


### notwithstanding article 7 , carriers , travel agents and tour operators may refuse to accept a reservation from , to issue or otherwise provide a ticket to or to embark a person , on the grounds of disability or of reduced mobility : ### notwithstanding article 7 , carriers , travel agents and tour operators may refuse to accept a reservation from , to issue or otherwise provide a ticket to or to embark a person with a disability or reduced mobility on the basis of this regulation :


### in order to meet applicable health and safety requirements established by international , union or national law or in order to meet health and safety&#160 ; requirements established by the competent authorities ; ### in order to meet applicable safety requirements established by international , union or national law or in order to meet safety&#160 ; requirements established by the competent authorities ;


### where the design of the passenger ship or port infrastructure and equipment , including port terminals , makes it impossible to carry out the embarkation , disembarkation or carriage of the disabled person or person with reduced mobility in a safe or operationally feasible manner . ### where the design of the passenger ship or port infrastructure and equipment , including port terminals , makes it impossible to carry out the embarkation , disembarkation or carriage of the said person in a safe or operationally feasible manner .


### in the event of a refusal to accept a reservation or to issue or otherwise provide a ticket on the grounds referred to in paragraph 1 , carriers , travel agents and tour operators shall make reasonable efforts to propose to the person concerned an acceptable alternative transport on a passenger service or a cruise operated by the carrier . ### in the event of a refusal to accept a reservation or to issue or otherwise provide a ticket on the grounds referred to in paragraph 1 , carriers , travel agents and tour operators shall make all reasonable efforts to propose to the person concerned an acceptable alternative transport on a passenger service or a cruise operated by the carrier .


### if a disabled person or a person with reduced mobility , who holds a reservation or has a ticket and has complied with the requirements in article 11 , is any way denied embarkation on the grounds of his disability or reduced mobility , that person and any accompanying person pursuant to paragraph 4 of this article shall be offered the choice between the right to reimbursement and re - routing as provided for in annex i . the right to the option of a return journey or re - routing shall be conditional upon all health and safety requirements being met . ### if a disabled person or a person with reduced mobility , who holds a reservation or has a ticket and has complied with the requirements in article 11 , is any way denied embarkation , on the basis of this regulation , that person and any accompanying person pursuant to paragraph 4 of this article shall be offered the choice between the right to reimbursement and re - routing as provided for in annex i . the right to the option of a return journey or re - routing shall be conditional upon all safety requirements being met .


### when carriers , travel agents and tour operators have recourse to paragraphs 1 or 4 , they shall immediately inform the disabled person or person with reduced mobility of the specific reasons therefor . those reasons shall be notified to the disabled person or person with reduced mobility , no later than five working days after that person was informed . in case of refusal according to paragraph 1 , reference shall be made to the applicable health and safety requirements . ### when carriers , travel agents and tour operators have recourse to paragraphs 1 or 4 , they shall immediately inform the disabled person or person with reduced mobility of the specific reasons therefor . on request , those reasons shall be notified to the disabled person or person with reduced mobility in writing , no later than five working days after the request . in case of refusal according to paragraph 1 , reference shall be made to the applicable safety requirements .


### in cooperation with organisations representative of disabled persons or persons with reduced&#160 ; mobility , carriers and terminal operators shall , where appropriate through their organisations , establish , or have in place , non - discriminatory access conditions for the transport of disabled persons and persons with reduced mobility . ### in cooperation with organisations representative of disabled persons or persons with reduced&#160 ; mobility , carriers , port authorities and terminal operators shall , where appropriate through their organisations , establish , or have in place , non - discriminatory access conditions for the transport of disabled persons and persons with reduced mobility and accompanying persons . the access conditions shall be notified to national enforcement bodies .


### the access conditions provided for in paragraph 1 shall be made publicly available by carriers and terminal operators physically or on the internet in the same languages as those in which information is generally made available to all passengers . ### the access conditions provided for in paragraph 1 shall be made publicly available by carriers , port authorities and terminal operators physically or on the internet in accessible formats and in the same languages as those in which information is generally made available to all passengers . particular attention shall be paid to the needs of people with disabilities and persons with reduced mobility .


### subject to the access conditions provided for in article 9 , carriers and terminal operators shall , within their respective areas of competence , provide assistance free of charge to disabled persons and persons with reduced mobility , as specified in annexes ii and iii , in ports , including embarkation and disembarkation , and on board ships . ### subject to the access conditions provided for in article 9 , carriers and terminal operators shall , within their respective areas of competence , provide assistance free of charge to disabled persons and persons with reduced mobility , as specified in annexes ii and iii , in ports , including embarkation and disembarkation , and on board ships . the assistance shall , if possible , be adapted to the individual needs of the person with a disability or reduced mobility .


### the carrier or the terminal operator is notified of the person ' s need for such assistance at&#160 ; the&#160 ; latest two&#160 ; working&#160 ; days before the assistance is needed , and ; ### the carrier or the terminal operator is notified of the person ' s need for such assistance at&#160 ; the&#160 ; latest 48 hours before the assistance is needed , unless a shorter period is agreed between the passenger and the carrier , and ;


### if no embarkation time is stipulated , no later than 60 minutes before the published departure time . ### if no embarkation time is stipulated , no later than 30 minutes before the published departure time .


### in addition to paragraph 1 , disabled persons or persons with reduced mobility shall notify the carrier , at the time of reservation or advance purchase of the ticket , of their specific needs with regard to accommodation or seating or their need to bring medical equipment , provided the need is known at that time . ### in addition to paragraph 1 , disabled persons or persons with reduced mobility shall notify the carrier , at the time of reservation or advance purchase of the ticket , of their specific needs with regard to accommodation , seating or services required or their need to bring medical equipment , provided the need is known at that time .


### a notification made in accordance with paragraphs 1 and 2 may always be submitted to the travel agent or the tour operator with which the ticket was purchased . where the ticket permits multiple journeys , one notification shall be sufficient provided that adequate information on the timing of subsequent journeys is provided . ### a notification made in accordance with paragraphs 1 and 2 may always be submitted to the travel agent or the tour operator with which the ticket was purchased . where the ticket permits multiple journeys , one notification shall be sufficient provided that adequate information on the timing of subsequent journeys is provided . the passenger shall receive a confirmation stating that the assistance needs have been notified as required .


### carriers , terminal operators , travel agents and tour operators shall take all measures necessary for the reception of notifications made in accordance with article&#160 ; 11 and&#160 ; 11 . that obligation shall apply at all their points of sale , including sale by&#160 ; telephone and over the internet . ### carriers , terminal operators , travel agents and tour operators shall take all measures necessary for the request and reception of notifications made in accordance with article&#160 ; 11 and&#160 ; 11 . that obligation shall apply at all their points of sale , including sale by&#160 ; telephone and over the internet .


### terminal operators and carriers operating port terminals or passenger services with a total of more&#160 ; than&#160 ; 100&#160 ; 000 commercial&#160 ; passenger movements during the previous calendar&#160 ; year shall , within their respective areas of competence , set quality standards for the assistance specified in annexes&#160 ; ii and&#160 ; iii and shall , where&#160 ; appropriate through their organisations , determine resource requirements for meeting those standards , in cooperation with organisations representative of disabled persons and persons with reduced mobility . ### terminal operators and carriers shall , within their respective areas of competence , set quality standards for the assistance specified in annexes&#160 ; ii and&#160 ; iii and shall , where&#160 ; appropriate through their organisations , determine resource requirements for meeting those standards , in cooperation with organisations representative of disabled persons and persons with reduced mobility .


### moreover , every effort shall be undertaken to rapidly provide temporary replacement equipment . ### moreover , every effort shall be undertaken to rapidly provide temporary suitable replacement equipment .


### in the case of a cancellation or a delay in departure of a passenger service or a cruise , passengers departing from port terminals shall be informed by the carrier or , where&#160 ; appropriate , by the terminal operator , of the situation as&#160 ; soon as&#160 ; possible and in&#160 ; any&#160 ; event no&#160 ; later&#160 ; than 30&#160 ; minutes after the scheduled time of departure , and of the estimated departure time and estimated arrival time as soon as this information is available . ### in the case of a cancellation or a delay in departure of a passenger service or a cruise , passengers shall be informed by the carrier or , where&#160 ; appropriate , by the terminal operator , of the situation as&#160 ; soon as&#160 ; possible and in&#160 ; any&#160 ; event no&#160 ; later&#160 ; than 30&#160 ; minutes after the scheduled time of departure , and of the estimated departure time and estimated arrival time as soon as this information is available .


### in the case of a cancellation or a delay in departure where a stay of one or more nights or a stay additional to that intended by the passenger becomes necessary , where and when physically possible , the carrier shall offer passengers departing from port terminals adequate accommodation free of charge on board , or ashore , and transport to and from the port terminal and place of accommodation in addition to the snacks , meals or refreshments provided for in paragraph 1 . for each passenger , the carrier may limit the total cost of accommodation ashore , not including transport to and from the port terminal and place of accommodation , to eur 120 . ### in the case of a cancellation or a delay in departure where a stay of one or more nights or a stay additional to that intended by the passenger becomes necessary , where and when physically possible , the carrier shall offer passengers departing from port terminals adequate accommodation free of charge on board , or ashore , and transport to and from the port terminal and place of accommodation in addition to the snacks , meals or refreshments provided for in paragraph 1 . for each passenger , the carrier may limit the total cost of accommodation ashore , not including transport to and from the port terminal and place of accommodation , to eur 120 per night .


### where a carrier reasonably expects a passenger service to be cancelled or delayed in departure from a port terminal for more than 120 minutes , the passenger shall immediately be offered the choice between : ### where a carrier reasonably expects a passenger service to be cancelled or delayed in departure from a port terminal for more than 90 minutes , the passenger shall immediately be offered the choice between :


### if the delay exceeds double the time set out in points to , the compensation shall be 50 % of the ticket price . ### if the delay exceeds double the time set out in points to , the compensation shall be 75 % of the ticket price .


### the compensation of the ticket price shall not be reduced by financial transaction costs such as fees , telephone costs or stamps . carriers may introduce a minimum threshold under which payments for compensation will not be paid . this threshold shall not exceed eur 10 . ### the compensation of the ticket price shall not be reduced by financial transaction costs such as fees , telephone costs or stamps . carriers may introduce a minimum threshold under which payments for compensation will not be paid . this threshold shall not exceed eur 4 .


### article 17 shall not apply where the cancellation or delay is caused by weather conditions endangering the safe operation of the ship . ### article 17 shall not apply where the carrier can prove that the cancellation or delay is caused by weather conditions endangering the safe operation of the ship .


### article 19 shall not apply where the cancellation or delay is caused by weather conditions endangering the safe operation of the ship or by extraordinary circumstances hindering the performance of the passenger service , which could not have been avoided even if all reasonable measures had been taken . ### article 19 shall not apply where the carrier can prove that the cancellation or delay is caused by weather conditions endangering the safe operation of the ship or by extraordinary circumstances hindering the performance of the passenger service , which could not have been avoided even if all reasonable measures had been taken .


### carriers and terminal operators shall , within their respective areas of competence , provide passengers with adequate information throughout their travel in accessible formats and in the same languages as those in which information is generally made available to all passengers . particular attention shall be paid to the needs of disabled persons and persons with reduced mobility . ### carriers and terminal operators shall , within their respective areas of competence , provide passengers with adequate information throughout their travel in accessible formats and in the same languages as those in which information is generally made available to all passengers . this information shall be provided according to a common conceptual model for public transport data and systems . particular attention shall be paid to the needs of disabled persons and persons with reduced mobility .


### carriers and terminal operators shall , within their respective areas of competence , ensure that information on the rights of passengers under this regulation is publicly available on&#160 ; board ships and in port&#160 ; terminals . the information shall be provided in accessible&#160 ; formats and in the same languages as those in which information is generally made available to all passengers . when providing this information particular attention shall be paid to the needs of disabled persons and persons with reduced mobility . ### carriers , port authorities and terminal operators shall , within their respective areas of competence , ensure that information on the rights of passengers under this regulation is publicly available on&#160 ; board ships , in ports and in port&#160 ; terminals . the information shall be provided in accessible&#160 ; formats and in the same languages as those in which information is generally made available to all passengers . when providing this information particular attention shall be paid to the needs of disabled persons and persons with reduced mobility .


### in order to comply with the information requirement referred to in paragraph 1 , carriers and terminal operators may use a summary of the provisions of this regulation prepared by the commission in all the official languages of the institutions of the european union and made available to them . ### in order to comply with the information requirement referred to in paragraph 1 , carriers , port authorities and terminal operators may use a summary of the provisions of this regulation prepared by the commission in all the official languages of the institutions of the european union and made available to them .


### carriers and terminal operators shall inform passengers in an appropriate manner on board ships and in port terminals , of the contact details of the enforcement body designated by the member state pursuant to article 25 . ### carriers , port authorities and terminal operators shall inform passengers in an appropriate manner on board ships , in ports and in port terminals , of the contact details of the enforcement body designated by the member state pursuant to article 25 .


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


### each member state shall designate a new or existing body or bodies responsible for the enforcement of this regulation as regards passenger services and cruises from ports situated on its territory and passenger services from a third&#160 ; country to such ports . each&#160 ; body shall take the measures necessary to ensure compliance with this regulation . each body shall , in its organisation , funding decisions , legal structure and decision - making , be independent of carriers , tour operators and terminal operators . ### each member state shall designate a new or existing body or bodies responsible for the enforcement of this regulation as regards passenger services and cruises from ports situated on its territory and passenger services from a third&#160 ; country to such ports . each&#160 ; body shall take the measures necessary to ensure compliance with this regulation . each body shall , in its organisation , funding decisions , legal structure and decision - making , be independent of commercial interests .


### that the passenger as a first step shall submit the complaint covered by this regulation to the carrier ; and / or ### that the passenger as a first step shall submit the complaint covered by this regulation to the carrier or terminal operator ; and / or


### on 1 june … and every two years thereafter , the enforcement bodies designated pursuant to article 25 shall publish a report on their activity in the previous two calendar years , containing in particular a description of actions taken in order to implement the provisions of this regulation , details of sanctions applied and statistics on complaints and sanctions applied . ### on 1&#160 ; june &#8230 ; and every two&#160 ; years thereafter , the enforcement bodies designated pursuant to article&#160 ; 25 shall publish a report on their activity in the previous two calendar&#160 ; years , containing in&#160 ; particular a description of actions taken in order to implement the provisions of this regulation , details of sanctions applied and statistics on complaints , including on their outcome and resolution timescales , and sanctions applied .


### national enforcement bodies referred to in article 25 shall , whenever appropriate , exchange information on their work and decision - making principles and practice . the commission shall support them in this task . ### national enforcement bodies referred to in article 25 shall exchange information on their work and decision - making principles and practice . the commission shall support them in this task .


### it shall apply from . + __________________________  oj : 36 months after the date of publication of this regulation . ### it shall apply from . + __________________________  oj : 12 months after the date of publication of this regulation .


### – communicate their arrival at a port terminal and their request for assistance , ### – communicate their arrival at a port and their request for assistance ,


### temporary replacement of damaged or lost mobility equipment , albeit not necessarily on a like for like basis . ### temporary replacement of damaged or lost mobility equipment with equivalent equipment .


### where pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production elsewhere . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land . ### where pasture or agricultural land previously destined for the food , feed and fibre markets is diverted to biofuel production , the non - fuel demand will still need to be satisfied either through intensification of current production or by bringing non - agricultural land into production elsewhere . this can be achieved either through an increase in agricultural production or through increased agricultural productivity . the latter case represents indirect land - use change and when it involves the conversion of high carbon stock land it can lead to significant greenhouse gas emissions . directives 98 / 70 / ec and 2009 / 28 / ec should therefore include provisions to address indirect land use change given that current biofuels are mainly produced from crops grown on existing agricultural land .


### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework . ### liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions . advanced biofuels , such as those made from wastes and algae , provide high greenhouse gas savings with no risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets . after prior scientific assessment about their merits and their true sustainability . it is appropriate , therefore , to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities , in part due to competition for public subsidies with established food crop based biofuel technologies . further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in directive 2009 / 28 / ec compared to conventional biofuels . in this context , only advanced biofuels which meet sustainability criteria , which do not compete with food for land , water or other resources and which have no estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy framework .


### ' for the purpose of compliance with target referred to in the first subparagraph , the maximum joint contribution from biofuels and bioliquids produced from cereal and other starch rich crops , sugars and oil crops shall be no more than the energy quantity corresponding to the maximum contribution as set out in article 3d . ' ### ' for the purpose of compliance with target referred to in the first subparagraph , the maximum joint contribution from biofuels and bioliquids produced from cereal and other starch rich crops , sugars , oil crops and other energy crops shall be no more than the energy quantity corresponding to the maximum contribution as set out in article 3d . '


### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from cereal and other starch rich crops , sugars and oil crops shall be no more than 5% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 . ### for the calculation of biofuels in the numerator , the share of energy from biofuels produced from cereal and other starch rich crops , sugars , oil crops and other energy crops shall be no more than 5% , the estimated share at the end of 2011 , of the final consumption of energy in transport in 2020 .


### full harmonisation of some key regulatory aspects will considerably increase legal certainty for both consumers and business . both consumers and business will be able to rely on a single regulatory framework based on clearly defined legal concepts regulating certain aspects of business - to - consumer contracts across the community . the effect will be to eliminate the barriers stemming from the fragmentation of the rules and to complete the internal market in this area . these barriers can only be eliminated by establishing uniform rules at community level . furthermore consumers will enjoy a high common level of protection across the community . ### unless otherwise specified and in accordance with article 169 of the treaty on the functioning of the european union , the measures laid out in the present directive should not prevent member states from maintaining or introducing measures providing for a higher level of consumer protection . however , full harmonisation of some key regulatory aspects is justified to ensure a consistent framework of consumer protection across the european union and to considerably increase legal certainty for both consumers and business in cross border transactions . in these cases , both consumers and business will be able to rely on a single regulatory framework based on clearly defined legal concepts regulating certain aspects of business - to - consumer contracts across the community . the effect should be that consumers enjoy a high common level of protection across the european unions , contribute to eliminate the barriers stemming from the inadequate fragmentation of the rules and to complete the internal market in this area .


### the existing community legislation on consumer financial services contains numerous rules on consumer protection . for this reason the provisions of this directive cover contracts relating to financial services only insofar as this is necessary to fill the regulatory gaps . ### whilst the existing community legislation on consumer financial services contains numerous rules on consumer protection , consumers in the field of financial services should profit of the measures provided in the present directive insofar as this is necessary to fill the regulatory gaps . these measures should also apply horizontally where a higher level of consumer protection that the one provided in the special financial national or eu legislation is granted .


### the purpose of this directive is to contribute to the proper functioning of the internal market and achieve a high level of consumer protection by approximating certain aspects of the laws , regulations and administrative provisions of the member states concerning contracts between consumers and traders . ### the purpose of this directive is to achieve a high level of consumer protection ensuring the proper functioning of the internal market by approximating certain aspects of the laws , regulations and administrative provisions of the member states concerning contracts between consumers and traders .


### ' trader ' means any natural or legal person who , in contracts covered by this directive , is acting for purposes relating to his trade , business , craft or profession and anyone acting in the name of or on behalf of a trader ; ### ' trader ' means any natural or legal person who , in contracts covered by this directive , is acting for purposes relating to his trade , business , craft or profession and anyone acting in the name of or on behalf of a trader ; in the case of financial services , the special requirements provided for in the eu sectorial financial legislation should be regarded ;


### this directive shall only apply to financial services as regards certain off - premises contracts as provided for by articles 8 to 20 , unfair contract terms as provided for by articles 30 to 39 and general provisions as provided for by articles 40 to 46 , read in conjunction with article 4 on full harmonisation . ### this directive shall apply to financial services without prejudice to national or eu special financial legislation providing for a higher level of consumer protection .


### the consumer shall be exempted from the provision of any consideration in cases of unsolicited supply of a product as prohibited by article 5 and point 29 of annex i of directive 2005 / 29 / ec . the absence of a response from the consumer following such an unsolicited supply shall not constitute consent . ### the consumer shall be exempted from the provision of any consideration in cases of unsolicited supply of a product as prohibited by article 5 and point 29 of annex i of directive 2005 / 29 / ec . the absence of a response from the consumer following such an unsolicited supply shall not constitute consent . not withstanding the right of objection of employees , this shall not prevent employers from automatically enrolling employees into their workforce pension schemes if this was out on employers contributions . it should also not prevent the tacit renewal of insurance , credit and other financial contracts whereby they are automatically renewed upon expiry following explicit contract provisions .


### unless other union legislation requires archiving for a longer period , the sponsor and the investigator shall archive the content of the clinical trial master file for at least five years after the end of the clinical trial . however , the medical files of subjects shall be archived in accordance with national legislation . ### unless other union legislation requires archiving for a longer period , the sponsor and the investigator shall archive the content of the clinical trial master file for a period of five years after the end of the clinical trial . however , the medical files of subjects shall be archived in accordance with national legislation .


### the eu database shall contain personal data only insofar as this is necessary for the purposes of paragraph 2 . ### the eu database shall contain personal data only insofar as this is necessary for the purposes of paragraph 2 . in no case personal data of patients participating in a clinical trial shall be processed in the eu database .


### the commission and member states shall ensure that the data subject may effectively exercise his or her rights to information , to access , to rectify and to object in accordance with regulation no 45 / 2001 and national data protection laws implementing directive 95 / 46 / ec respectively . they shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected and erased . within their respective responsibilities , the commission and member states shall ensure that inaccurate and unlawfully processed data is deleted , in accordance with the applicable legislation . corrections and deletions shall be carried out as soon as possible , but no later than within 60 days after a request being made by a data subject . ### the commission and member states shall ensure that the data subject may effectively exercise his or her rights to information , to access , to rectify ; to block and to object in accordance with regulation no 45 / 2001 and national data protection laws implementing directive 95 / 46 / ec respectively . they shall ensure that the data subject may effectively exercise the right of access to data relating to him or her , and the right to have inaccurate or incomplete data corrected , blocked and erased . within their respective responsibilities , the commission and member states shall ensure that inaccurate and unlawfully processed data is deleted , in accordance with the applicable legislation . corrections , blocking and deletions shall be carried out as soon as possible , but no later than within 60 days after a request being made by a data subject .