### where , within two months of receipt of the notification referred to in article 70 , objections are raised by a member state against a provisional measure taken by another member state , or where the commission considers the measure to be contrary to union legislation , the commission shall evaluate the national measure . on the basis of the results of that evaluation , the commission shall decide , by means of implementing acts , whether or not the national measure is justified . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### where , within one month of receipt of the notification referred to in article 70 , objections are raised by a member state against a provisional measure taken by another member state , or where the commission considers the measure to be contrary to union legislation , the commission shall evaluate the national measure . on the basis of the results of that evaluation , the commission shall decide , by means of implementing acts , whether or not the national measure is justified . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### where , having performed an evaluation pursuant to article 69 , a member state finds that although a device has been legally placed on the market or put into service , it presents a risk to the health or safety of patients , users or other persons or to other aspects of the protection of public health , it shall require the relevant economic operator or operators to take all appropriate provisional measures to ensure that the device concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the device from the market or to recall it within a reasonable period , proportionate to the nature of the risk . ### where , having performed an evaluation pursuant to article 69 , a member state finds that although a device has been legally placed on the market or put into service , it presents a risk to the health or safety of patients , users or other persons or to other aspects of the protection of public health , it shall immediately require the relevant economic operator or operators to take all appropriate provisional measures to ensure that the device concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the device from the market or to recall it within a reasonable period , proportionate to the nature of the risk .


### without prejudice to article 70 , a member state shall require the relevant economic operator to put an end to the non - compliance concerned within a reasonable period that is proportionate to the non - compliance where it makes one of the following findings : ### without prejudice to article 70 , a member state shall require the relevant economic operator to put an end to the non - compliance concerned within a reasonable period that is clearly defined and communicated and that is proportionate to the non - compliance where it makes one of the following findings :


### where the economic operator does not put an end to the non - compliance within the period referred to in paragraph 1 , the member state concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market . that member state shall inform the commission and the other member states without delay of those measures , by means of the electronic system referred to in article 68 . ### where the economic operator does not put an end to the non - compliance within the period referred to in paragraph 1 , the member state concerned shall immediately take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market . that member state shall inform the commission and the other member states immediately of those measures , by means of the electronic system referred to in article 68 .


### except in cases where immediate action is necessary for reasons of serious risk to human health or safety , the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time before any measure is adopted . if action has been taken without the economic operator being heard , he shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter . ### except in cases where immediate action is necessary for reasons of serious risk to human health or safety , the economic operator concerned shall be given the opportunity to make submissions to the competent authority within an appropriate period of time that is clearly defined before any measure is adopted . if action has been taken without the economic operator being heard , he shall be given the opportunity to make submissions as soon as possible and the action taken shall be reviewed promptly thereafter .


### any measure adopted shall be immediately withdrawn or amended upon the economic operator ' s demonstrating that he has taken effective corrective action . ### any measure adopted shall be immediately withdrawn or amended upon the economic operator ' s satisfactorily demonstrating that he has taken effective corrective action .


### the member states shall designate the competent authority or authorities responsible for the implementation of this regulation . they shall entrust their authorities with the powers , resources , equipment and knowledge necessary for the proper performance of their tasks pursuant to this regulation . the member states shall communicate the competent authorities to the commission which shall publish a list of competent authorities . ### the member states shall designate the competent authority or authorities responsible for the implementation of this regulation . they shall entrust their authorities with the powers , resources , equipment and knowledge necessary for the proper performance of their tasks pursuant to this regulation . the member states shall communicate the competent authorities to the commission which shall publish a list of competent authorities and their contact details .


### the competent authorities of the member states shall cooperate with each other and with the commission and exchange with each other the information necessary to enable this regulation to be applied uniformly . ### the competent authorities of the member states shall cooperate with each other and with the commission and with the mdcg as appropriate and exchange with each other and the commission the information necessary to enable this regulation to be applied uniformly .


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


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


### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organisations participating in the sub - groups of the mdcg . ### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry or in the supply chain which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry or in the supply chain and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organisations participating in the sub - groups of the mdcg .


### members of the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . upon request , the declaration of interests shall be accessible to the public . this article shall not apply to the representatives of stakeholder organisations participating in the sub - groups of the mdcg . ### members of the mdcg , of the advisory panels to the mdcg and staff of the eu reference laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality . they shall undertake to act in the public interest and in an independent manner . they shall declare any direct and indirect interests they may have in the medical device industry and update this declaration whenever a relevant change occurs . the declaration of interests shall be made publicly available on the european commission web site .


### 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 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 structure and level of fees shall be publicly available on request .


### the power to adopt the delegated acts referred to in articles 2 and , 4 , 8 , 17 , 24 , 25 , 29 , 40 , 41 , 42 , 45 , 51 , 53 , 74 and 81 is conferred on the commission subject to the conditions laid down in this article . ### the power to adopt the delegated acts referred to in articles 2 and , 4 , 8 , 17 , 24 , 25 , 29 , 40 , 74 and 81 is conferred on the commission subject to the conditions laid down in this article .


### the delegation of power referred to in articles 2 and , 4 , 8 , 17 , 24 , 25 , 29 , 40 , 41 , 42 , 45 , 51 , 53 , 74 and 81 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation . ### the delegation of power referred to in articles 2 and , 4 , 8 , 17 , 24 , 25 , 29 , 40 , 74 and 81 shall be conferred on the commission for an indeterminate period of time from the date of entry into force of this regulation .


### the delegation of power referred to in articles 2 and , 4 , 8 , 17 , 24 , 25 , 29 , 40 , 41 , 42 , 45 , 51 , 53 , 74 and 81 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following its publication in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force . ### the delegation of power referred to in articles 2 and , 4 , 8 , 17 , 24 , 25 , 29 , 40 , 74 and 81 may be revoked at any time by the european parliament or by the council . a decision of revocation shall put an end to the delegation of the power specified in that decision . it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein . it shall not affect the validity of any delegated acts already in force .


### reduce as far as possible the remaining risks by taking adequate protection measures , including alarms ; and ### reduce as far as possible the remaining risks by taking adequate protection measures , including alarms ; hence , it should take into consideration the latest tools and concepts developed in hazard and risk assessment based on human - relevant models , pathways of toxicity , adverse outcome pathways and evidence - based toxicology ; and


### 4 . the devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device . special attention shall be given to substances which are carcinogenic , mutagenic or toxic to reproduction , in accordance with part 3 of annex vi to regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures , amending and repealing directives 67 / 548 / eec and 1999 / 45 / ec , and amending regulation no 1907 / 2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in article 59 of regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals . ### 4 . the devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device . substances which are carcinogenic , mutagenic or toxic to reproduction , in accordance with part 3 of annex vi to regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures , amending and repealing directives 67 / 548 / eec and 1999 / 45 / ec , and amending regulation no 1907 / 2006 , shall be phased out within 8 years from the entry into force of this regulation , unless no safer alternative substances are available . in the case that no safer alternatives exist , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , within the technical documentation and , within the instructions for use , information on residual risks for these patient groups and , if applicable , on appropriate precautionary measures . devices containing substances having endocrine disrupting properties that come into contact with the body of patients and for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in article 59 of regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals and in accordance with the endocrine disrupting substances’ criteria set out in the report of the endocrine disrupters expert advisory group shall be phased out within 8 years from the entry into force of this regulation , unless no safer alternative substances are available . in the case that no safer alternatives exist , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , within the technical documentation and , within the instructions for use , information on residual risks for these patient groups and , if applicable , on appropriate precautionary measures .


### 7 . devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device and / or of any waste substances by the user , patient or other person . ### 7 . devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device , of substances with which it has been treated and / or of any waste substances by the user , patient or other person and , where possible and appropriate , the device shall be replaced with a device with a higher safety standard . this should particularly be intended to reduce dangers to patients and users which may arise from exposure to chemical or nuclear material .


### devices shall be designed and manufactured and packaged in such a way that exposure of patients , users and other persons to any emitted radiation shall be reduced as far as possible and appropriate , compatible with the intended purpose , whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes . ### devices shall be designed and manufactured and packaged in such a way that exposure of patients , users and other persons to any emitted radiation shall be reduced as far as possible and appropriate , compatible with the intended purpose , and if possible these applications shall be replaced with applications with a higher safety standard , whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes .


### devices shall be designed and manufactured in such a way that exposure of patients , users and other persons to the emission of unintended , stray or scattered radiation is reduced as far as possible and appropriate . ### devices shall be designed and manufactured in such a way that exposure of patients , users and other persons to the emission of unintended , stray or scattered radiation is reduced as far as possible and appropriate : where possible , methods should be selected which reduce the exposure to radiation of patients , users and other persons who may be affected .


### devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that , where possible , the quantity , geometry and energy distribution of radiation emitted can be varied and controlled taking into account the intended use . ### devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that , where possible , the quantity , geometry and energy distribution of radiation emitted can be varied and controlled taking into account the intended use , and if possible , devices should be used that can at any time during and after treatment monitor the emission of radiation .


### the details strictly necessary for a user to identify the device , the contents of the packaging and , where it is not obvious for the user , the intended purpose of the device . ### the details strictly necessary for a user to identify the device , the contents of the packaging and , where it is not obvious for the user , the intended purpose of the device and where applicable that the device is only to be used during a single procedure .


### the ce marking shall consist of the initials ' ce ' taking the following form : ### the ce marking shall consist of the initials &#8220 ; ce&#8221 ; with the addition of the words ' medical device ' taking the following form :


### the ce marking shall consist of the initials ' ce ' taking the following form : ### the ce marking shall consist of the initials ' ce ' accompanied by the term ' medical device ' taking the following form :


### 1 . 1 . a notified body shall be capable of carrying out all the tasks assigned to it by this regulation with the highest degree of professional integrity and the requisite technical competence in the specific field , whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility . ### 1 . 1 . a notified body shall be capable of carrying out all the tasks assigned to it by this regulation with the highest degree of professional integrity and the requisite technical competence in the specific field , whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility . the process shall be monitored to ensure that it is of the requisite quality .


### 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 availability within its organisation of sufficient scientific personnel who possess experience , a university degree and the knowledge required 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 .


### 2 . 1 . the notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities and the required training . the qualification criteria shall address the various functions within the conformity assessment process as well as the devices , technologies and areas covered by the scope of designation . ### 2 . 1 . the mdcg shall establish and document the principals of high level competence and qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities and the required training . the qualification criteria shall address the various functions within the conformity assessment process as well as the devices , technologies and areas covered by the scope of designation .


### 2 . 5 . the personnel responsible for carrying out product related review shall have the following proven qualification : ### 2 . 5 . the personnel responsible for carrying out product related review shall have the required specialist qualifications stipulated by the member states . the required specialist qualifications include , for example :


### 2 . 6 . the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have the following proven qualification : ### 2 . 6 . the personnel responsible for carrying out audits of the manufacturer ' s quality management system shall have the required specialist qualifications stipulated by the member states . the required specialist qualifications include , for example :


### 1 . the notified body ' s decision - making process shall be clearly documented , including the process for the issue , suspension , reinstatement , withdrawal or refusal of conformity assessment certificates , their modification or restriction and the issue of supplements . ### 1 . the notified body ' s decision - making process shall be clearly documented and publicly available , including the process for the issue , suspension , reinstatement , withdrawal or refusal of conformity assessment certificates , their modification or restriction and the issue of supplements .


### 1 . the notified body ' s decision - making process shall be clearly documented , including the process for the issue , suspension , reinstatement , withdrawal or refusal of conformity assessment certificates , their modification or restriction and the issue of supplements . ### 1 . the notified body ' s decision - making process must be transparent and shall be clearly documented , including the process for the issue , suspension , reinstatement , withdrawal or refusal of conformity assessment certificates , their modification or restriction and the issue of supplements .


### 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 :


### all devices incorporating or consisting of nanomaterial are in class iii unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient ' s or user ' s body when the device is used within its intended purpose . ### all devices incorporating or consisting of nanomaterial intended to be intentionally released in the human body are classified as class iii .


### all devices incorporating or consisting of nanomaterial are in class iii unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user ' s body when the device is used within its intended purpose . ### all devices incorporating or consisting of nanomaterial deliberately intended to be released into the body are in class iii .


### all devices incorporating or consisting of nanomaterial are in class iii unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user ' s body when the device is used within its intended purpose . ### all devices whose mode of functioning entails the deliberate release of nanomaterial into the human body are in class iii .


### all devices incorporating or consisting of nanomaterial are in class iii unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user ' s body when the device is used within its intended purpose . ### all devices incorporating or consisting of nanomaterial intended to be intentionally released in the human body are classified as class iii .


### devices that are composed of substances or combination of substances intended to be ingested , inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body are in class iii . ### devices that are composed of substances or combination of substances primarily intended to be ingested , inhaled or administered rectally or vaginally and that are absorbed by and dispersed in the human body in order to achieve their intended purpose are in class iii .


### 1 . the aim of surveillance is to ensure that the manufacturer duly fulfils the obligations imposed by the approved quality management system . ### 1 . the aim of surveillance is to ensure that the manufacturer duly fulfils all the obligations imposed by the approved quality management system .


### 4 . the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , of the manufacturer ' s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 . or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer . ### 4 . the notified body shall randomly perform at least once every five years and for each manufacturer and generic device group unannounced inspections at the relevant manufacturing sites and , if appropriate , at the manufacturer ' s suppliers and / or subcontractors , the notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer . at the time of such inspections , the notified body shall carry out the tests or ask to carry them in order to check that the quality management system is working properly . it shall provide the manufacturer with an inspection report and with a test report .


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


### the notified body shall randomly perform unannounced factory inspections to the manufacturer and , if appropriate , at the manufacturer ' s suppliers and / or subcontractors , which may be combined with the periodic surveillance assessment referred to in section 4 . 3 . or be performed in addition to this surveillance assessment . the notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturer . ### the notified body shall randomly perform at least once every five years and for each manufacturer and generic device group unannounced inspections at the relevant manufacturing sites and , if appropriate , at the manufacturer ' s suppliers and / or subcontractors , the notified body shall establish a plan for the unannounced inspections which shall not take a periodicity lower than one inspection per year and must not be disclosed to the manufacturer . at the time of such inspections , the notified body shall carry out the tests or ask to carry them in order to check that the quality management system is working properly . it shall provide the manufacturer with an inspection report and with a test report .


### the notified body shall examine the application employing staff with proven knowledge and experience regarding the technology concerned . the notified body may require the application to be completed by further tests or other evidence to allow assessment of conformity with the requirements of the regulation . the notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests . ### the notified body shall examine the application employing staff with proven knowledge and experience regarding the technology concerned . the notified body shall ensure that the manufacturer’s application adequately describes the design , manufacture and performance of the device , allowing assessment of whether the product conforms with the requirements set out in this regulation . the notified bodies shall comment on the conformity of the following : - general description of the product , - design specifications , including a description of the solutions adopted to fulfil the essential requirements , - systematic procedures used for the design process and techniques used to control , monitor and verify the design of the device . the notified body may require the application to be completed by further tests or other evidence to allow assessment of conformity with the requirements of the regulation . the notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests .


### confirmation of conformity with the requirements concerning the characteristics and performances referred to in section 1 of annex i , under the normal conditions of use of the device , and the evaluation of the undesirable side - effects and of the acceptability of the benefit / risk ratio referred to in sections 1 and 5 of annex i , shall be based on clinical data . ### confirmation of conformity with the requirements concerning the characteristics and performances referred to in section 1 of annex i , under the normal conditions of use of the device , and the evaluation of the undesirable side - effects and of the acceptability of the benefit / risk ratio referred to in sections 1 and 5 of annex i , shall be based on clinical data . data from independent scientific institutions or medical societies based on their own collections of clinical data shall also be taken into account .


### post - market clinical follow - up , hereinafter : pmcf , is a continuous process to update the clinical evaluation referred to in article 49 and part a of this annex and shall be part of the manufacturer ' s post - market surveillance plan . to this end , the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which is authorised to bear the ce marking , within its intended purpose as referred to in the relevant conformity assessment procedure , with the aim of confirming the safety and performance throughout the expected lifetime of the device , the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence . ### post - market clinical follow - up , hereinafter : pmcf , is a continuous process to update the clinical evaluation referred to in article 49 and part a of this annex and shall be part of the manufacturer ' s post - market surveillance plan . to this end , the manufacturer shall proactively collect , register in the electronic system on vigilance referred to in article 62 and evaluate clinical data from the use in or on humans of a device which is authorised to bear the ce marking , within its intended purpose as referred to in the relevant conformity assessment procedure , with the aim of confirming the safety and performance throughout the expected lifetime of the device , the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence .


### the manufacturer shall analyse the findings of the pmcf and document the results in a pmcf evaluation report that shall be part of the technical documentation . ### the manufacturer shall analyse the findings of the pmcf and document the results in a pmcf evaluation report that shall be part of the technical documentation and be sent periodically to the concerned member states .


### the conclusions of the pmcf evaluation report shall be taken into account for the clinical evaluation referred to in article 49 and part a of this annex and in the risk management referred to in section 2 of annex i . if through the pmcf the need for corrective measures has been identified , the manufacturer shall implement them . ### the conclusions of the pmcf evaluation report shall be taken into account for the clinical evaluation referred to in article 49 and part a of this annex and in the risk management referred to in section 2 of annex i . if through the pmcf the need for corrective measures has been identified , the manufacturer shall implement them and inform the concerned member states .


### every step in the clinical investigation , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects , adopted by the 18th world medical association general assembly in helsinki , finland , in 1964 , and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . ### every step in the clinical investigation , from first consideration of the need and justification of the study to the publication of the results , shall be carried out in accordance with recognised ethical principles , as for example those laid down in the world medical association declaration of helsinki on ethical principles for medical research involving human subjects adopted by the 18th world medical assembly in helsinki , finland , in 1964 and last amended by the 59th world medical association general assembly in seoul , korea , in 2008 . regulation of the detailed requirements relating to the participation of subjects in clinical trials shall be the responsibility of the member states .


### 7 . the clinical investigation report , signed by the medical practitioner or other authorised person responsible , shall contain a critical evaluation of all the data collected during the clinical investigation , including negative findings . ### 7 . the clinical investigation report , signed by the medical practitioner or other authorised person responsible , shall contain all clinical data collected during the clinical investigation and a critical evaluation of such data , including negative findings .


### 1 . 3 . information on the principal investigator , coordinating investigator , including their qualifications , and on the investigation site . ### 1 . 3 . information on the principal investigator , coordinating investigator , including their qualifications , and on the investigation site , as well as information about the contract between the sponsor and the investigating establishment , together with details of the funding .


### 1 . 4 . overall synopsis of the clinical investigation . ### 1 . 4 . overall synopsis of the clinical investigation in the national language of the country concerned .


### this regulation should provide sufficient safeguards against abuse of the order . in particular , unless the creditor already has a judgment enforceable in the member state of enforcement , the court should be able to require the creditor to provide security to ensure compensation for any damage suffered by the debtor as a result of an unjustified order . the conditions under which the creditor will be liable to compensate the debtor for such damage should be governed by national law . where the law of a member state does not provide for a statutory liability of the claimant , this regulation should not preclude the recourse to measures with equivalent effect , such as the obligation on the claimant to give an undertaking as to damages . ### this regulation should provide sufficient safeguards against abuse of the order . in particular , unless the creditor already has a judgment enforceable in the member state of enforcement , the court should be able to require the creditor to provide security to ensure compensation for any damage suffered by the debtor as a result of an unjustified order , the amount to be set by the relevant court depending on the amount of the debt . the conditions under which the creditor will be liable to compensate the debtor for such damage should be governed by national law . where the law of a member state does not provide for a statutory liability of the claimant , this regulation should not preclude the recourse to measures with equivalent effect , such as the obligation on the claimant to give an undertaking as to damages .


### this regulation shall apply to pecuniary claims in civil and commercial matters having cross - border implications as defined in article 3 whatever the nature of the court or tribunal . it shall not extend , in particular , to revenue , customs or administrative matters . ### this regulation shall apply to claims in civil and commercial matters having cross - border implications as defined in article 3 whatever the nature of the court or tribunal . it shall not extend , in particular , to revenue , customs or administrative matters .


### this regulation shall not apply to bank accounts which , under the law governing immunity from enforcement of the member state where the account is located , are exempt from seizure or to systems for the settlement of securities designated by member states in accordance with article 10 of directive 98 / 26 / ec of the european parliament and of the council . ### this regulation shall not apply to bank accounts which , under the law governing immunity from enforcement of the member state where the account is located , are exempt from seizure or to accounts opened for the setting up of payment systems and systems for the settlement of securities designated by member states in accordance with article 10 of directive 98 / 26 / ec of the european parliament and of the council .


### for the purposes of this regulation , a matter is considered to have cross - border implications unless the court seized with the application for an eapo , all bank accounts to be preserved by the order and the parties are located or domiciled in the same member state . ### for the purposes of this regulation a matter has cross - border implications if any of the following : - the court seized with the application for an eapo , - any of the bank accounts to be preserved by the order , or - any of the parties are not domiciled in the same member state .


### ‘ bank’ means an undertaking the business of which is to receive deposits or other repayable funds from the public and to grant credits for its own account ; ### ‘ bank’ means a credit institution the business of which is to receive deposits or other repayable funds from the public and to grant credits for its own account ;


### relates to the signature and the content of the instrument , and ### relates to the signature , content of the instrument , determination of the identity of the parties , endorsement by the latter of the content and date of the instrument , and


### the claimant applies for an eapo prior to the initiation of judicial proceedings on the substance of the matter against the defendant or at any stage during such proceedings ; ### the creditor applies for an eapo prior to the initiation of judicial proceedings on the substance of the matter against the debtor or at any stage during such proceedings ;


### the claimant has obtained a judgment , court settlement or authentic instrument against the defendant which is enforceable in the member state of origin but has not yet been declared enforceable in the member state of enforcement where such a declaration is required . ### the creditor has obtained a judgment , court settlement or authentic instrument against the debtor which is enforceable in the member state of origin but has not yet been declared enforceable in the member state of enforcement where such a declaration is required .


### section 2 applies to situations where the claimant applies for an eapo after having obtained a judgment , court settlement or authentic instrument against the defendant which is by operation of law enforceable in the member state of enforcement or has been declared enforceable there . ### section 2 applies to situations where the creditor applies for an eapo after having obtained a judgment , court settlement or authentic instrument against the debtor which is by operation of law enforceable in the member state of enforcement or has been declared enforceable there .


### jurisdiction for issuing the eapo shall lie with the courts of the member state where proceedings on the substance of the matter have to be brought in accordance with the applicable rules on jurisdiction . where more than one court has jurisdiction for the substance of the matter , the court of the member state where the claimant has brought proceedings on the substance or intends to bring proceedings on the substance shall have jurisdiction ### jurisdiction for issuing the eapo shall lie with the courts of the member state where proceedings on the substance of the matter have to be brought in accordance with the applicable rules on jurisdiction . where more than one court has jurisdiction for the substance of the matter , the court of the member state where the claimant has brought proceedings on the substance shall have jurisdiction .


### that the claim against the defendant appears to be well founded ; ### that the claim against the defendant is well founded ;


### where the claimant has already obtained a judgment , court settlement or authentic instrument for the payment of a sum of money against the defendant which is enforceable in the member state of origin and entitled to recognition in the member state of enforcement under the applicable instruments of union law , the condition set out in paragraph 1 shall be deemed to be fulfilled . ### the condition set out in paragraph 1 shall be deemed to be fulfilled where the claimant has already obtained a judgment , court settlement or authentic instrument enforceable in the member state of origin and entitled to recognition in the member state of enforcement under the applicable instruments of union law , under which it is established or ascertained that the claim relates to payment being sought through an account preservation order application .


### where an application for an eapo is made prior to the initiation of proceedings on the substance , the claimant shall initiate such proceedings within 30 days of the date of issue of the order or within any shorter time period set by the issuing court , failing which the order shall be revocable in accordance with point of article 34 or article 35 . ### where an application for an eapo is made prior to the initiation of proceedings on the substance , the claimant shall initiate such proceedings within 30 calendar days of the date of issue of the order or within any shorter time period set by the issuing court , failing which the order shall be revocable in accordance with point of article 34 or article 35 .


### either ### or any of the following :


### the possibility to oblige all banks in their territory to disclose whether the defendant holds an account with them . ### the possibility to oblige all banks in their territory to inform the competent authorities whether the defendant holds an account with them .


### where the claimant obtained a judgment , authentic instrument or court settlement on the substance which is enforceable in the member state of origin or in cases referred to in article 5 , until the effect of the eapo is replaced by an equivalent effect of an enforcement measure under national law , provided that in the former case the claimant has launched the enforcement proceedings within 30 days after the judgment , authentic instrument or court settlement has been notified or has become enforceable , whichever is the later . ### where the claimant obtained a judgment , authentic instrument or court settlement on the substance which is enforceable in the member state of origin or in cases referred to in article 5 , until the effect of the eapo is replaced by an equivalent effect of an enforcement measure under national law , provided that in the former case the claimant has launched the enforcement proceedings within 30 calendar days after the judgment , authentic instrument or court settlement has been notified or has become enforceable , whichever is the later .


### an appeal is to be lodged within 30 days of notification of the decision referred to in paragraph 1 . ### an appeal is to be lodged within 30 calendar days of notification of the decision referred to in paragraph 1 .


### the defendant shall be served with the eapo and all documents submitted to the court or competent authority with a view to obtaining the order without undue delay after service on the bank has been effected pursuant to article 24 and the bank has issued the declaration pursuant to article 27 . ### no more than one working day after service on the bank has been effected pursuant to article 24 and the bank has issued the declaration pursuant to article 27 , the defendant shall be served with the eapo and all documents submitted to the court or competent authority with a view to obtaining the order .


### where the currency of the funds held in the account is not the same as that in which the eapo was issued , the bank shall convert the amount by reference to the official exchange rate of the day of implementation . ### where the currency of the funds held in the account is not the same as that in which the eapo was issued , the bank shall convert the amount by reference to the official exchange rate of the day of implementation in the member state in which the account is located .


### with the exception of a review pursuant to paragraph 1 , the application for a review shall be made promptly , in any event within 45 days from the day the defendant was effectively acquainted with the contents of the order and was able to react . ### with the exception of a review pursuant to paragraph 1 , the application for a review shall be made promptly , in any event within 45 calendar days from the day the defendant was effectively acquainted with the contents of the order and was able to react .


### the application shall be served on the claimant in accordance with the applicable rules on the service of documents . ### the application shall be served on the claimant by the court in accordance with the applicable rules on the service of documents .


### the decision will be immediately served on the bank or banks concerned which shall immediately upon receipt implement the decision by unblocking the amount preserved fully or partially . it will also be immediately served to the claimant in accordance with the applicable rules on the service of documents . ### the decision will be immediately served by the court on the bank or banks concerned which shall immediately upon receipt implement the decision by unblocking the amount preserved fully or partially . it will also be immediately served by the court to the claimant in accordance with the applicable rules on the service of documents .


### following the review , certain provisions of the regulations should be amended in order to improve transparency and predictability , provide for effective measures to fight against retaliation , improve effectiveness and enforcement and optimise review practice . in addition , certain practices that in recent years have been applied in the context of anti - dumping and anti - subsidy investigations should be included in the regulations . ### following the review , certain provisions of the regulations should be amended in order to improve transparency and predictability , provide for effective measures to fight against retaliation , improve effectiveness and enforcement and optimise review practice .


### following the review , certain provisions of the regulations should be amended in order to improve transparency and predictability , provide for effective measures to fight against retaliation , improve effectiveness and enforcement and optimise review practice . in addition , certain practices that in recent years have been applied in the context of anti - dumping and anti - subsidy investigations should be included in the regulations . ### following the review , certain provisions of the regulations should be amended in order to improve transparency and predictability , provide for effective measures to fight against retaliation , improve effectiveness and enforcement and optimise review practice , and to facilitate access to the instruments for smes . to this end , the function of the export helpdesk should be adapted . in addition , certain practices that in recent years have been applied in the context of anti - dumping and anti - subsidy investigations should be included in the regulations .


### if in special circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation . ### in article 5 , paragraph 6 shall be replaced by the following : 6 . if , in special circumstances or in the case of diverse and fragmented industry sectors , largely composed of small - and medium - sized enterprises , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### if in special circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation . ### if , in special circumstances , such as in , but not limited to , case of diverse and fragmented industry sectors , or in the case of threats of retaliation by a third country or its industry against eu industry , or its individual members , wishing to file a complaint under article 5 of this regulation , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### if , in special circumstances , the commission decides to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of the existence of countervailable subsidies , injury and causal link , as described in paragraph 2 , to justify such initiation . ### article 10 shall be replaced by the following : 8 . if , in special circumstances or in the case of diverse and fragmented industry sectors , largely composed of small - and medium - sized enterprises , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### if , in special circumstances , the commission decides to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of the existence of countervailable subsidies , injury and causal link , as described in paragraph 2 , to justify such initiation . ### if , in special circumstances , such as in , but not limited to , case of diverse and fragmented industry sectors , or in the case of threats of retaliation by a third country or its industry against eu industry , or its individual members , wishing to file a complaint under article 5 of this regulation , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation .


### if in special circumstances , it is decided to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation . ### in article 5 , paragraph 6 is replaced by the following : ' 6 . if , in the case of diverse and fragmented industry sectors , largely composed of small - and medium - sized enterprises , it is decided to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of dumping , injury and a causal link , as described in paragraph 2 , to justify such initiation . '


### if , in special circumstances , the commission decides to initiate an investigation without having received a written complaint by or on behalf of the community industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of the existence of countervailable subsidies , injury and causal link , as described in paragraph 2 , to justify such initiation . ### in article 10 , paragraph 8 is replaced by the following : ' 8 . if , in the case of diverse and fragmented industry sectors , largely composed of small - and medium - sized enterprises , the commission decides to initiate an investigation without having received a written complaint by or on behalf of the union industry for the initiation of such investigation , this shall be done on the basis of sufficient evidence of the existence of countervailable subsidies , injury and causal link , as described in paragraph 2 , to justify such initiation . '


### for proceedings initiated pursuant to article 10 , an investigation shall , whenever possible , be concluded within one year . in any event , such investigations shall in all cases be concluded within 13 months of their initiation , in accordance with the findings made pursuant to article 13 for undertakings or the findings made pursuant to article 15 for definitive action . ### in article 11 shall be replaced by the following : 9 . for proceedings initiated pursuant to article 10 , an investigation shall be concluded within one year , in accordance with the findings made pursuant to article 13 for undertakings or the findings made pursuant to article 15 for definitive action .


### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . the lesser duty shall not be applied if the price of the principle costs of production , such as primary or secondary raw materials or energy , of the product concerned are found to be structurally distorted and do not materially reflect market prices of such inputs .


### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . such a lesser duty shall not apply in the following circumstances : - structural raw material or energy distortions were found to exist with regard to the product concerned in the exporting country . criteria to determine the distortion should be duly specified . - the investigation or a separate anti - subvention investigation has established at least provisionally that the exporting country provides one or more subsidies to exporting producers of the product concerned .


### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . unless significant state interferences regarding , inter alia , prices , costs and inputs , including for instance raw materials and energy , research and labour , outputs , sales and investments , currency exchange rate and fair trade finance conditions , were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury in the union industry .


### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established , but it should be less than the margin if such lesser duty would be adequate to remove the injury to the community industry . 2b ) such a lesser duty shall not apply in any of the following circumstances : - structural distortions or significant state interferences regarding , inter alia , prices , costs and inputs , including for instance raw materials and energy , research and labour , outputs , sales and investments , currency exchange rate and fair trade finance conditions , were found to exist with regard to the product concerned in the exporting country ; - the exporting country does not have a sufficient level of social and environmental standards , where sufficient levels are determined on the basis of the ratification and effective implementation by the third country of multilateral environmental agreements , and protocols thereunder , the eu is party to at any point in time and of ilo conventions listed in annex i ; - the complainant represents a diverse and fragmented industry , largely composed of small - and - medium - sized enterprises ; - the investigation or a separate anti - subsidy investigation has established at least provisionally that the exporting country provides one or more subsidies to exporting producers of the product concerned . 2 c ) however , such a lesser duty shall always be granted when structural raw materials distortions are found to exist with regard to the product concerned in the exporting country and such country is a least - developed country listed in annex iv to regulation no 978 / 2012 of the european parliament and of the council .


### the amount of the anti - dumping duty shall not exceed the margin of dumping established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the provisional anti - dumping duty shall not exceed the margin of dumping as provisionally established . the lesser duty shall not be applied if the price of the principle costs of production , such as primary or secondary raw materials or energy , of the product concerned are found to be structurally distorted and do not materially reflect market prices of such inputs .


### the amount of the anti - dumping duty shall not exceed the margin of dumping established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the anti - dumping duty shall not exceed the margin of dumping established , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . such a lesser duty shall not apply in the following circumstances : - structural raw material or energy distortions were found to exist with regard to the product concerned in the exporting country . criteria to determine the distortion should be duly specified . - the investigation or a separate anti - subvention investigation has established at least provisionally that the exporting country provides one or more subsidies to exporting producers of the product concerned .


### the amount of the anti - dumping duty shall not exceed the margin of dumping established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the definitive anti - dumping duty shall not exceed the margin of dumping established . unless significant state interferences regarding , inter alia , prices , costs and inputs , including for instance raw materials and energy , research and labour , outputs , sales and investments , currency exchange rate and fair trade finance conditions , were found to exist with regard to the product concerned in the exporting country , it should be less than the margin of dumping if such lesser duty would be adequate to remove the injury in the union industry . '


### the amount of the anti - dumping duty shall not exceed the margin of dumping established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the anti - dumping duty shall not exceed the margin of dumping established . the lesser duty shall not be applied if the price of the principle costs of production , such as primary or secondary raw materials or energy , of the product concerned are found to be structurally distorted and do not materially reflect market prices of such inputs .


### the amount of the anti - dumping duty shall not exceed the margin of dumping established . unless structural raw material distortions were found to exist with regard to the product concerned in the exporting country , it shall be less than the margin of dumping if such lesser duty would be adequate to remove the injury to the union industry . ### the amount of the anti - dumping duty shall not exceed the margin of dumping established but it should be less than the margin if such lesser duty would be adequate to remove the injury to the community industry . 2 b ) such a lesser duty shall not apply in any of the following circumstances : - structural distortions or significant state interferences regarding , inter alia , prices , costs and inputs , including for instance raw materials and energy , research and labour , outputs , sales and investments , currency exchange rate and fair trade finance conditions , were found to exist with regard to the product concerned in the exporting country ; - the exporting country does not have a sufficient level of social and environmental standards , where sufficient levels are determined on the basis of the ratification and effective implementation by the third country of multilateral environmental agreements , and protocols thereunder , the eu is party to at any point in time and of ilo conventions listed in annex i ; - the complainant represents a diverse and fragmented industry , largely composed of small - and - medium - sized enterprises ; - the investigation or a separate anti - subsidy investigation has established that the exporting country provides one or more subsidies to exporting producers of the product concerned . 2 c ) however , such a lesser duty shall always be granted when structural raw materials distortions are found to exist with regard to the product concerned in the exporting country and such country is a least - developed country listed in annex iv to regulation no 978 / 2012 of the european parliament and of the council .


### parties which offer an undertaking shall be required to provide a non - confidential version of such undertaking , so that it may be made available to interested parties to the investigation . ### article 8 shall be replaced by the following : 4 . parties which offer an undertaking shall be required to timely provide meaningful non - confidential version of such undertaking including as detailed as possible disclosure of its content and nature , so that it may be made available to interested parties to the investigation for their comments . furthermore , the commission shall consult the union industry with regard to the main features and operation of the undertaking before accepting any such offer .


### ' 4 . parties which offer an undertaking shall be required to provide a non - confidential version of such undertaking , so that it may be made available to interested parties to the investigation . ' ### article 13 shall be replaced by the following : ' 4 . parties which offer an undertaking shall be required to timely provide meaningful non - confidential version of such undertaking including as detailed as possible disclosure of its content and nature , so that it may be made available to interested parties to the investigation for their comments . furthermore , the commission shall consult the union industry with regard to the main features and operation of the undertaking before accepting any such offer . '


### a definitive anti - dumping measure shall expire five years from its imposition or five years from the date of the conclusion of the most recent review which has covered both dumping and injury , unless it is determined in a review that the expiry would be likely to lead to a continuation or recurrence of dumping and injury . such an expiry review shall be initiated on the initiative of the commission , or upon request made by or on behalf of community producers , and the measure shall remain in force pending the outcome of such review . an expiry review shall be initiated where the request contains sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of dumping and injury . such likelihood may , for example , be indicated by evidence of continued dumping and injury or evidence that the removal of injury is partly or solely due to the existence of measures or evidence that the circumstances of the exporters , or market conditions , are such that they would indicate the likelihood of further injurious dumping . in carrying out investigations under this paragraph , the exporters , importers , the representatives of the exporting country and the community producers shall be provided with the opportunity to amplify , rebut or comment on the matters set out in the review request , and conclusions shall be reached with due account taken of all relevant and duly documented evidence presented in relation to the question as to whether the expiry of measures would be likely , or unlikely , to lead to the continuation or recurrence of dumping and injury . a notice of impending expiry shall be published in the official journal of the european union at an appropriate time in the final year of the period of application of the measures as defined in this paragraph . thereafter , the community producers shall , no later than three months before the end of the five - year period , be entitled to lodge a review request in accordance with the second subparagraph . a notice announcing the actual expiry of measures pursuant to this paragraph shall also be published . ### in article 11 , paragraph 2 is replaced by the following : ‘ 2 . a definitive anti - dumping measure shall expire five years from its imposition or five years from the date of the conclusion of the most recent review which has covered both dumping and injury , unless it is determined in a review that the expiry would be likely to lead to a continuation or recurrence of dumping and injury . such an expiry review shall be initiated on the initiative of the commission , or upon request made by or on behalf of community producers , and the measure shall remain in force pending the outcome of such review . an expiry review shall be initiated where the request contains sufficient evidence that the expiry of the measures would be likely to result in a continuation or recurrence of dumping and injury . such likelihood may , for example , be indicated by evidence of continued dumping and injury or evidence that the removal of injury is partly or solely due to the existence of measures or evidence that the circumstances of the exporters , or market conditions , are such that they would indicate the likelihood of further injurious dumping . such likelihood may also be indicated by continuing interference by other countries . in carrying out investigations under this paragraph , the exporters , importers , the representatives of the exporting country and the community producers shall be provided with the opportunity to amplify , rebut or comment on the matters set out in the review request , and conclusions shall be reached with due account taken of all relevant and duly documented evidence presented in relation to the question as to whether the expiry of measures would be likely , or unlikely , to lead to the continuation or recurrence of dumping and injury . ’


### member states shall report to the commission every month , on the import trade in products subject to investigation and to measures , and on the amount of duties collected pursuant to this regulation . ### in article 14 , paragraph 6 is replaced by the following : ‘ 6 . member states shall report to the commission every month , on the import trade in products subject to investigation and to measures , and on the amount of duties collected pursuant to this regulation . the commission may , upon receiving a specific reasoned request from an interested party , and after receiving the opinion of the advisory committee , decide to provide them with information concerning the volume and import values of these products . ’


### member states shall report to the commission every month , on the import trade in products subject to investigation and to measures , and on the amount of duties collected pursuant to this regulation . ### article 24 shall be replaced by the following : ‘ 6 . member states shall report to the commission every month , on the import trade in products subject to investigation and to measures , and on the amount of duties collected pursuant to this regulation . the commission may , upon receiving a specific reasoned request from an interested party , and after consulting the advisory committee , take decide to inform the interested parties about the volume and import values of these products . ’


### in cases where the number of union producers , exporters or importers , types of product or transactions is large , the investigation may be limited to a reasonable number of parties , products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection , or to the largest representative volume of production , sales or exports which can reasonably be investigated within the time available . ### in cases where the number of union producers , exporters or importers that cooperate in the investigation , or types of product or transactions is large , the investigation may be limited to a reasonable number of parties , products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection , or to the largest representative volume of production , sales or exports which can reasonably be investigated within the time available .


### ' 1 . in cases where the number of union producers , exporters or importers , types of product or transactions is large , the investigation may be limited to a reasonable number of parties , products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection , or to the largest representative volume of production , sales or exports which can reasonably be investigated within the time available . ' ### ' 1 . in cases where the number of union producers , exporters or importers , types of product or transactions is large , the investigation may be limited to a reasonable number of parties , products or transactions by using samples which are statistically valid on the basis of information available at the time of the selection , or to the largest representative volume of production , sales or exports which can reasonably be investigated within the time available . sampling shall include those parties , including non - complainant union producers . '


### the union producers , importers and exporters and their representative associations , and representatives of the exporting country , may request information on the planned imposition of provisional duties . requests for such information shall be made in writing within the time limit prescribed in the notice of initiation . such information shall be provided to those parties , at least two weeks before the expiry of the deadline mentioned in article 7 for the imposition of provisional duties . such information shall include : ### the union producers , importers and exporters and their representative associations , and representatives of the exporting country , may request information on the planned imposition of provisional duties . requests for such information shall be made in writing within the time limit prescribed in the notice of initiation . such information shall be provided to those parties , two weeks before the expiry of the deadline mentioned in article 7 for the imposition of provisional duties . such information shall include :


### this regulation shall enter into force on the day following that of its publication in the official journal of the european union . ### this regulation shall enter into force on the day following that of its publication in the official journal of the european union . it shall be available in consolidated form with the regulation it amends within three months of its entry into force .


### a delegated act adopted pursuant to article 2a shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to article 2a shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of two months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by four months at the initiative of the european parliament or the council .


### in article 10 , the full stop at the end of point is replaced by a semicolon , and the following is added after point : ' or by 15 december 2011 , for a request under article 9 , or by 15 june 2013 for a request under article 9 . ” ### article 10 is amended as follows : article 10 is replaced by the following : “1 . the commission shall examine the request accompanied by the information referred to in article 9 . when examining the request the commission shall take account of the findings of the relevant international organisations and agencies . it may ask the requesting country any questions which it considers relevant , and may verify the information received with the requesting country or with any other relevant sources , including the european parliament and representatives of civil society such as the social partners . ” in paragraph 3 , the full stop at the end of point is replaced by a semicolon , and the following is added after point : or by 15 december 2011 , for a request under article 9 , or by 15 june 2013 for a request under article 9 . ”


### proposal for a regulation of the european parliament and of the council establishing for the period 2014 to 2020 the rights and citizenship programme ### proposal for a regulation of the european parliament and of the council establishing for the period 2014 to 2020 the rights , equality and citizenship programme


### citizens should be able to exercise fully the rights deriving from the citizenship of the union . they should be able to exercise their right to move and reside freely in the union , their right to vote for and stand as a candidate in european parliament and municipal elections , their right to consular protection and their right to petition the european parliament . they should feel at ease about living , travelling and working in another member state , trusting that their rights are protected , no matter where in the union they happen to be . ### citizens should be able to exercise fully the rights deriving from the citizenship of the union . they should be able to exercise their right to move and reside freely in the union , their right to vote for and stand as a candidate in european parliament and municipal elections , their right to consular protection , their right to petition and submit citizens’ initiatives to the european parliament in any of the treaty languages and their right to lodge complaints with the european ombudsman against any act of maladministration . they should feel at ease about living , travelling , studying and working in another member state , trusting that they will enjoy equal access and the full enforceability and protection of their rights without discrimination , no matter where in the union they happen to be .


### citizens should be able to exercise fully the rights deriving from the citizenship of the union . they should be able to exercise their right to move and reside freely in the union , their right to vote for and stand as a candidate in european parliament and municipal elections , their right to consular protection and their right to petition the european parliament . they should feel at ease about living , travelling and working in another member state , trusting that their rights are protected , no matter where in the union they happen to be . ### eu citizens should be able to exercise fully the rights deriving from the citizenship of the union and from international conventions ratified by the european union , such as the united nations convention on the rights of persons with disabilities . they should be able to exercise their right to move and reside freely in the union , their right to vote for and stand as a candidate in european parliament and municipal elections in the country in which they reside , their right to consular protection and their right to petition the european parliament in any of the treaty languages . they should feel at ease about living , travelling , studying and working in another member state , trusting that their rights are protected , no matter where in the union they happen to be .


### non - discrimination based on sex , racial or ethnic origin religion or belief , disability , age or sexual orientation and equality between women and men are values common to the member states . combating all forms of discrimination is an ongoing goal which requires coordinated action , including by the allocation of funding . ### pursuant to articles 10 and 19 tfeu , the union is to aim to combat discrimination based on sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation and mainstream equality . non - discrimination is also enshrined in article 21 of the charter of fundamental rights of the european union . combating all forms of discrimination which require coordinated action , including by the allocation of funding .


### non - discrimination based on sex , racial or ethnic origin religion or belief , disability , age or sexual orientation and equality between women and men are values common to the member states . combating all forms of discrimination is an ongoing goal which requires coordinated action , including by the allocation of funding . ### non - discrimination based on sex , racial or ethnic origin religion or belief , disability , age or sexual orientation , protection of children and equality between women and men , as enshrined in articles 2 and 3 of the treaty on european union , articles 8 , 10 and 19 of the treaty on the functioning of the european union and articles 21 , 23 and 24 of the charter of fundamental rights of the european union , are values common to the member states . combating all forms of discrimination is an ongoing goal which requires coordinated action , including by the allocation of funding .


### non - discrimination based on sex , racial or ethnic origin religion or belief , disability , age or sexual orientation and equality between women and men are values common to the member states . combating all forms of discrimination is an ongoing goal which requires coordinated action , including by the allocation of funding . ### pursuant to articles 2 and 3 of the treaty on european union , articles 8 , 10 and 19 of the treaty on the functioning of the european union and article 21 of the charter , the union must combat all forms of discrimination , whether they are based on , for example , sex , racial or ethnic origin religion or belief , language , nationality or membership of a national minority , disability , age or sexual orientation and promote equality between women and men . it must guarantee respect for the values underpinning the union . mainstreaming equality and building an inclusive society by combating all forms of discrimination , intolerance and hatred are ongoing goals which require coordinated action , including by the allocation of sufficient funding .


### the communication from the commission on europe 2020 sets out a strategy for smart , sustainable and inclusive growth . supporting and promoting the rights of persons within the union , tackling discrimination and inequalities and promoting citizenship contribute to the promotion of the specific objectives and flagship initiatives of the europe 2020 strategy . ### the communication from the commission on europe 2020 sets out a strategy for smart , sustainable and inclusive growth . supporting and promoting the rights of persons within the union , promoting equality between women and men , tackling discrimination and inequalities , and promoting citizenship , contribute to the promotion of the specific objectives and flagship initiatives of the europe 2020 strategy .


### supporting and promoting the rights of persons within the union , tackling discrimination and inequalities and promoting citizenship contribute to the promotion of the specific objectives and flagship initiatives of the europe 2020 strategy . ### supporting and promoting the rights of persons within the union , tackling discrimination and inequalities and promoting union citizenship contribute to the promotion of the specific objectives and flagship initiatives of the europe 2020 strategy .


### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the european perception of the respect , exercise and implementation of these rights and the number of complaints . ### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the european perception of the respect , exercise and implementation of these rights , improved position of member states in internationally recognized human rights indices , and the number of successfully resolved complaints .


### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the european perception of the respect , exercise and implementation of these rights and the number of complaints . ### the indicators to measure the achievement of the objectives set out in paragraph 1 shall be , inter alia , the european perception of the respect , exercise and implementation of these rights , as well as the number and subjects of complaints and petitions regarding failures in their protection .


### training activities , such as staff exchanges , workshops , seminars , train - the - trainers events , development of online / other training modules ; ### training activities , such as staff exchanges , workshops , seminars , train - the - trainers events , development of online / other training modules , which are designed in close cooperation with civil society organisation and experts , include a global , cross - cutting gender dimension ; where relevant , these activities shall include the gender and anti - discrimination perspective and aim at preventing , combating and acknowledging gender - based violence and promoting equality between men and women ;


### support for main actors , such as support for member states when implementing union law and policies ; support for key european level networks whose activities are linked to the implementation of the objectives of the programme ; networking among specialised bodies and organisations , national , regional and local authorities at european level ; funding of experts ' networks ; funding of european level observatories . ### support for main actors , such as support for member states when implementing and applying union law and policies ; support for key european level networks , whose activities are linked to the implementation of the objectives of the programme ; networking among specialised bodies and organisations , national , regional and local authorities at european level ; improving the coordination of existing networks ; funding of experts ' networks ; funding of european level observatories .


### the commission , in cooperation with the member states , shall ensure overall consistency and complementarity and synergies with other union instruments , inter alia , with the justice programme , the europe for citizens programme and with programmes in the areas of home affairs ; employment and social affairs ; health and consumer protection ; education , training , youth and sport ; information society ; enlargement , in particular the instrument for pre - accession assistance and the funds operating under the common strategic framework . ### the commission , in cooperation with the member states , shall ensure overall consistency and complementarity and synergies with other union instruments , inter alia , with the justice programme , the europe for citizens programme and with programmes in the areas of home affairs ; employment and social affairs ; health and consumer protection ; education , training , youth and sport ; information society ; enlargement , in particular the instrument for pre - accession assistance and the funds operating under the common strategic framework . the commission shall also ensure overall consistency , complementarity and synergies with the eu agencies whose mandates cover the same domains as the programme .


### ‘ from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . ’ ### ' from 2020 : indicative specific emissions of co2 = 147 + a × where : m = mass of the vehicle in kilograms m0 = the value adopted pursuant to article 13 a = 0 , 096 . '


### the application of various national policies creates inconsistencies and fragmentation of the internal market which hamper the roll - out of union - wide services and the completion of the internal market for wireless broadband communications . it could in particular create unequal conditions for access to such services , hamper competition between undertakings established in different member states and stifle investments in more advanced networks and technologies and the emergence of innovative services , thereby depriving citizens and businesses of ubiquitous integrated high - quality services and wireless broadband operators of increased efficiency gains from large - scale more integrated operations . therefore , action at union level regarding certain aspects of radio spectrum assignment should accompany the development of wide integrated coverage of advanced wireless broadband communications services throughout the union . at the same time , member states should retain the right to adopt measures to organise their radio spectrum for public order , public security purposes and defence . ### the eu telecom package as revised in 2009 establishes the principles for spectrum management . it recognizes member states ' competence with respect to cultural and audiovisual policies and generally leaves them the necessary scope for action . therefore , action at union level regarding certain aspects of radio spectrum assignment should continue to endorse a dynamic approach to spectrum management , which recognizes member states ' competence in this field and respects the cultural , audiovisual and media policies of each member state . sufficient flexibility is needed to accommodate specific national requirements and member states should retain the right to adopt measures to organise their radio spectrum for public order , public security purposes and defence . in cases of disputes between member states over spectrum use , the commission may coordinate and support dispute settlement .


### in an open internet , providers of electronic communications to the public should , within contractually agreed limits on data volumes and speeds for internet access services , not block , slow down , degrade or discriminate against specific content , applications or services or specific classes thereof except for a limited number of reasonable traffic management measures . such measures should be transparent , proportionate and non - discriminatory . reasonable traffic management encompasses prevention or impediment of serious crimes , including voluntary actions of providers to prevent access to and distribution of child pornography . minimising the effects of network congestion should be considered reasonable provided that network congestion occurs only temporarily or in exceptional circumstances . ### in an open internet , providers of electronic communications to the public should not block , slow down , degrade or discriminate against specific content , applications or services or specific classes thereof except for a limited number of reasonable traffic management measures . such measures should be transparent , proportionate and non - discriminatory . reasonable traffic management encompasses prevention or impediment of serious crimes , including voluntary actions of providers to prevent access to and distribution of child pornography . minimising the effects of network congestion should be considered reasonable in demonstrated punctual cases of acute network congestion , provided that equivalent types of traffic are treated equally .


### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on flexible quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such flexible quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not substantially impair the general quality of internet access services . ### in addition , there is demand on the part of content , applications and services providers , for the provision of transmission services based on quality parameters , including lower levels of priority for traffic which is not time - sensitive . the possibility for content , applications and service providers to negotiate such special quality of service levels with providers of electronic communications to the public is necessary for the provision of specialised services and is expected to play an important role in the development of new services such as machine - to - machine communications . at the same time such arrangements should allow providers of electronic communications to the public to better balance traffic and prevent network congestion . providers of content , applications and services and providers of electronic communications to the public should therefore be free to conclude specialised services agreements on defined levels of quality of service as long as such agreements do not impair the general quality of open internet access services .


### in order to avoid bill shocks , end - users should be able to define maximum financial limits for the charges related to their usage of calls and internet access services . this facility should be available free of charge , with an appropriate notification that can be consulted again subsequently , when the limit is being approached . upon reaching the maximum limit , end - users should no longer receive or be charged for those services unless they specifically request the continued provision as agreed with the provider . ### in order to avoid bill shocks , end - users should be able to define maximum financial limits for the charges related to their usage of calls and internet access services . this facility should be available free of charge , with an appropriate notification that can be consulted again subsequently , when the limit is being approached .


### in addition , the significant reduction in mobile termination rates throughout the union in the recent past should now allow the elimination of additional roaming charges for incoming calls . ### in order to provide clarity and legal certainty , a date should be set for the final phasing out of retail roaming surcharges which reduction began with regulation no 717 / 2007 . in advance of that final abolition of retail surcharges , the wholesale rates should be further decreased and mobile termination rates should be harmonised , throughout the eu , in order to allow for a true level playing field for telecom operators .