### 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 . 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 . special attention shall be given to the recommendations from the ec scientific committees on their discussion paper ' addressing the new challenges for risk assessment – oct 2012 ' and reach review 49 final – feb 2013 ) which both acknowledged that ' toxicology is undergoing a transition towards a more mechanistic , pathway - based , cell - and computer - based approach assessing a substance ' s toxic mode of action ' .


### summary of safety and clinical performance in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 . ### safety and clinical performance report in the case of devices submitted for marketing authorisation procedure , other than custom - made or investigational devices , the manufacturer shall draw up a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation . the manufacturer shall also draw up a summary of that report which shall be written in a way that is easy for a lay person to understand . the draft of this report shall be part of the documentation to be submitted to and validated by the national authority or the agency , as relevant , involved in the marketing authorisation procedure . . 1a . the summary referred to in paragraph 1 shall be made available to the public via eudamed in accordance with provisions under article 27 and annex v , part a , point 18 . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in both the report and the summary referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 .


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


### products that contain or consist of biological substances or organisms other than those referred to in points and that are viable , including living micro - organisms , bacteria , fungi or virus ; ### products that contain or consist of biological substances or organisms other than those referred to in points and that are viable and that achieve their intended purpose by pharmacological , immunological or metabolic means , including certain living micro - organisms , bacteria , fungi or virus ;


### 1 . general 3 . 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 . in particular , it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified . 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 . 3 . 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . 3 . 1 . 3 . the notified body shall clearly document the extent and the limits of the duties , responsibilities and authorities in relation of the personnel involved in conformity assessment activities and inform the personnel concerned about it . ### 1 . general 3 . 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 . in particular , it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified . this presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified , having regard to the requirements of this regulation and , in particular , those set out in annex i . 3 . 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with pharmacological , medical and technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . 3 . 1 . 3 . the notified body shall clearly document the extent and the limits of the duties , responsibilities and authorities in relation of the personnel involved in conformity assessment activities and inform the personnel concerned about it . 3 . 1 . 3a . the notified body shall make available the list of its personnel and their expertise to the commission and , upon request , to other parties . that list shall be kept up to date .


### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing phthalates . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , 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 . ### shall not contain , in a concentration of 0 . 1% or above by mass per homogeneous material , substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , or substances identified as endocrine disrupters pursuant to the first subparagraph , unless the manufacturer can show that there are no suitable safer substances or devices without these substances . where the manufacturer can show that there are no suitable safer substances or devices without these substances , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b or substances identified as endocrine disrupters . the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for patients and , if applicable , on appropriate precautionary measures .


### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , giving details , in particular , of the non - compliance and of any corrective action taken . ### distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this regulation shall immediately inform the manufacturer and , where applicable , his authorised representative , the importer and the notified body responsible for monitoring the product if it is a class iia , iib or iii medical device , and the competent national authority . they shall make sure , within the scope of their respective activities , that the necessary corrective action to bring that device into conformity , withdraw or recall it , if appropriate , is taken . where the device presents a risk , they shall also immediately inform the competent authorities of the member states in which they made the device available , as well as the notified body responsible for evaluating the device if it is a class iia , iib or iii product , giving details , in particular , of the non - compliance and of any corrective action taken .


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


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


### 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 . 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 or 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 , or are known or presumed endocrine disrupters pursuant to commission recommendation on criteria for the identification of endocrine disrupters .


### 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 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 .


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


### all the information collated and processed by eudamed shall be accessible to the member states and to the commission . the information shall be accessible to notified bodies , economic operators , sponsors and the public to the extent defined in the provisions referred to in paragraph 2 . ### all the information collated and processed by eudamed shall be accessible to the member states and to the commission . the information shall be accessible to the agency , notified bodies , economic operators , sponsors , healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2 .


### the scope of application of this regulation should be clearly delimited from other union harmonisation legislation concerning products , such as in vitro diagnostic medical devices , medicinal products , cosmetics and food . therefore , regulation no 178 / 2002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law , establishing the european food safety authority and laying down procedures in matters of food safety should be amended to exclude medical devices from its scope . ### the scope of application of this regulation should be clearly delimited from other union harmonisation legislation concerning products , such as in vitro diagnostic medical devices , medicinal products , cosmetics and food . since in some cases it is difficult to distinguish between medical devices and cosmetic , medicinal or food products , the possibility to take an eu - wide decision regarding the regulatory status of a product should be introduced in regulation no 1223 / 2009 on cosmetic products , directive 2004 / 27 / ec on medicinal products for human use , regulation no 178 / 2002 on food law and food safety and directive 2002 / 46 / ec on food supplements . those union acts should therefore be amended .


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . 2 . the commission shall ensure the sharing of expertise between member states in the fields of medical devices , in vitro diagnostic medical devices , medicinal products , human tissues and cells , cosmetics , biocides , food and , if necessary , other products in order to determine the appropriate regulatory status of a product , or category or group of products . ### the commission may , at the request of a member state or on its own initiative , by means of implementing acts and on the basis of the opinion of the advisory committee referred to in article 78a , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' and if so , it shall determine the risk classification on the basis of the actual risk and scientific evidence . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### this regulation establishes rules to be complied with by medical devices and accessories to medical devices that are placed on the market or put into service in the union for human use . ### this regulation establishes rules to be complied with by medical devices for human use , accessories to medical devices and medical devices for aesthetic purposes that are placed on the market or put into service in the union .


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


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


### 2 . 4 . notified bodies shall have available personnel with clinical expertise . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : - identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts ; - appropriately train external clinical experts in the relevant requirements of this regulation , delegated and / or implementing acts , harmonised standards , cts and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided ; - be able to discuss the clinical data contained within the manufacturer ' s clinical evaluation with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation ; - be able to scientifically challenge the clinical data presented , and the results of the external clinical experts ' assessment of the manufacturer ' s clinical evaluation ; - be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts ; - be able to make an objective clinical judgement about the assessment of the manufacturer ' s clinical evaluation and make a recommendation to the notified body ' s decision maker . ### 2 . 4 . clinical experts : notified bodies shall have available , on a permanent basis , personnel with expertise in clinical investigation design , medical statistics , clinical patient management , good clinical practice in the field of clinical investigations and pharmacology . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : - identify when specialist input is required for the assessment of the clinical investigation plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts ; - appropriately train external clinical experts in the relevant requirements of this regulation , delegated and / or implementing acts , harmonised standards , cts and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided ; - be able to discuss the rationale of the planned study design , the clinical investigation plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation ; - be able to scientifically challenge the clinical investigation plans and the clinical data presented , and the results of the external clinical experts ' assessment of the manufacturer ' s clinical evaluation ; - be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts ; - be able to make an objective clinical judgement about the assessment of the manufacturer ' s clinical evaluation and make a recommendation to the notified body ' s decision maker . - provide an understanding of active substances .


### summary of safety and clinical performance ### safety and clinical performance report


### summary of safety and clinical performance in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 . ### safety and clinical performance report in the case of devices submitted for marketing authorisation procedure , other than custom - made or investigational devices , the manufacturer shall draw up a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation . the manufacturer shall also draw up a summary of that report which shall be written in a way that is easy for a lay person to understand . the draft of this report shall be part of the documentation to be submitted to and validated by the national authority or the agency , as relevant , involved in the marketing authorisation procedure . . 1a . the summary referred to in paragraph 1 shall be made available to the public via eudamed in accordance with provisions under article 27 and annex v , part a , point 18 . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in both the report and the summary referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 .


### the data shall be entered into eudamed by the member states , notified bodies , economic operators and sponsors as specified in the provisions concerning the electronic systems referred to in paragraph 2 . ### the data shall be entered into eudamed by the agency , the member states , notified bodies , economic operators , sponsors and healthcare professionals as specified in the provisions concerning the electronic systems referred to in paragraph 2 .


### in the single application , the sponsor shall propose one of the member states concerned as coordinating member state . if that member state does not wish to be the coordinating member state , it shall agree , within six days of submission of the single application , with another member state concerned that the latter shall be the coordinating member state . if no other member state accepts to be the coordinating member state , the member state proposed by the sponsor shall be the coordinating member state . if another member state than the one proposed by the sponsor becomes coordinating member state , the deadline referred to in article 51 shall start on the day following the acceptance . ### concerned member states shall agree , within six days of submission of the single application , which member state shall be the coordinating member state . member states and the commission shall agree , in the framework of the attributions of the mdcg , on clear rules for designating the coordinating member state .


### after the expiry of 35 days after the validation date referred to in paragraph 4 , unless the member state concerned has notified the sponsor within that period of its refusal based on considerations of public health , patient safety or public policy . ### after the expiry of 60 days after the validation date referred to in paragraph 4 , unless the member state concerned has notified the sponsor within that period of its refusal based on considerations of public health , patient safety or public policy .


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


### at least once a year , the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in annex vi . this assessment shall include an on - site visit to each notified body . ### at least once a year , the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in annex vi , and whether the body’s subsidiaries and subcontractors satisfy those requirements . this assessment shall include an on - site visit to each notified body , and to any subsidiaries or subcontractors it has , within or outside the union .


### experts and other third parties invited by the mdcg on a case - by - case basis shall be requested to declare their interests in the issue in question . ### experts participating in the advisory committee referred to in article 78a shall be requested to declare their interests in the issue in question .


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


### transparency and better information are essential to empower patients and healthcare professionals and to enable them to make informed decisions , to provide a sound basis for regulatory decision - making and to build confidence in the regulatory system . ### transparency and adequate access to information , appropriately presented for the intended user , are essential to empower patients , users and healthcare professionals and to enable them to make informed decisions , to provide a sound basis for regulatory decision - making and to build confidence in the regulatory system .


### the manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device . ### the manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device . the implant card shall also be made available in an electronic format , and member states shall ensure that hospitals and clinics keep an electronic version on record , so that it can be easily forwarded at the request of a patient .


### 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 . for class iii medical devices , the manufacturer ' s pmcf evaluation report shall be reviewed by an independent scientific body , such as an academic institution or a medical society . in order to conduct its review , the manufacturer shall provide the relevant data to the independent scientific body . both the manufacturer ' s pmcf evaluation report and its review by an independent scientific body shall be part of the technical documentation for class iii medical devices .


### it should be the responsibility of the member states to decide on a case - by - case basis whether or not a product falls within the scope of this regulation . if necessary , the commission may decide , on a case - by - case basis , whether or not a product falls within the definition of a medical device or of an accessory to a medical device . since in some cases it is difficult to distinguish between medical devices and cosmetic products , the possibility to take an eu - wide decision regarding the regulatory status of a product should also be introduced in regulation no 1223 / 2009 of the european parliament and of the council of 30 november 2009 on cosmetic products ### in order to ensure consistent classification across all member states , particularly with regards to borderline cases , it should be the responsibility of the commission to decide on a case - by - case basis whether or not a product or groups of products fall within the scope of this regulation .


### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing phthalates . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , 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 . ### shall not contain , in a concentration of 0 . 1% or above by mass per homogeneous material , substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , or substances identified as endocrine disrupters pursuant to the first subparagraph , unless the manufacturer can show that there are no suitable safer substances or devices without these substances . in case the manufacturer can show that there are no suitable safer substances or devices without these substances , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b or substances identified as endocrine disrupters . the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for patients and , if applicable , on appropriate precautionary measures .


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


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


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


### the implantable or other invasive products , intended to be used for human beings , which are listed in annex xv shall be considered medical devices , regardless of whether or not they are intended by the manufacturer to be used for a medical purpose . ### the implantable or other invasive products , as well as products using external physical agents , intended to be used for human beings , which are listed on a non - exhaustive basis in annex xv , shall be considered medical devices for the purposes of this regulation , regardless of whether or not they are intended by the manufacturer to be used for a medical purpose .


### the scope of application of this regulation should be clearly delimited from other union harmonisation legislation concerning products , such as in vitro diagnostic medical devices , medicinal products , cosmetics and food . therefore , regulation no 178 / 2002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law , establishing the european food safety authority and laying down procedures in matters of food safety should be amended to exclude medical devices from its scope . ### the scope of application of this regulation should be clearly delimited from other union harmonisation legislation concerning products , such as in vitro diagnostic medical devices , medicinal products , cosmetics and food . since in some cases it is difficult to distinguish between medical devices and cosmetic , medicinal or food products , the possibility to take an eu - wide decision regarding the regulatory status of a product should be introduced in regulation no 1223 / 2009 on cosmetic products , directive 2004 / 27 / ec on medicinal products for human use , regulation no 178 / 2002 on food law and food safety and directive 2002 / 46 / ec on food supplements . those union acts should therefore be amended .


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


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


### devices incorporating a substance considered to be a medicinal product and devices composed of substances or combination of substances intended to be ingested , inhaled or administered rectally or vaginally ### devices incorporating a substance considered to be a medicinal product


### labels shall be provided in a human - readable format but may be supplemented by machine - readable forms , such as radio - frequency identification or bar codes . ### labels shall be provided in a human - readable format and shall be supplemented by machine - readable forms , such as radio - frequency identification or bar codes .


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


### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing phthalates . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , 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 . ### shall not contain , in a concentration of 0 . 1% or above by mass per homogeneous material , substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b in accordance with part 3 of annex vi to regulation no 1272 / 2008 , or substances identified as endocrine disrupters pursuant to the first subparagraph , unless the manufacturer can show that there are no suitable safer substances or devices without these substances . where the manufacturer can show that there are no suitable safer substances or devices without these substances , these devices shall be labelled on the device itself and / or on the packaging for each unit or , where appropriate , on the sales packaging as devices containing substances which are classified as carcinogenic , mutagenic or toxic to reproduction of category 1a or 1b or substances identified as endocrine disrupters . the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , in particular of this paragraph , within the technical documentation and , within the instructions for use , information on residual risks for patients and , if applicable , on appropriate precautionary measures .


### 1 . general 3 . 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 . in particular , it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified . 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 . 3 . 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . 3 . 1 . 3 . the notified body shall clearly document the extent and the limits of the duties , responsibilities and authorities in relation of the personnel involved in conformity assessment activities and inform the personnel concerned about it . ### 1 . general 3 . 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 . in particular , it shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified . this presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified , having regard to the requirements of this regulation and , in particular , those set out in annex i . 3 . 1 . 2 . at all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified , a notified body shall have within its organisation the necessary administrative , technical and scientific personnel with pharmacological , medical and technical knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks , including the assessment of clinical data . 3 . 1 . 3 . the notified body shall clearly document the extent and the limits of the duties , responsibilities and authorities in relation of the personnel involved in conformity assessment activities and inform the personnel concerned about it . 3 . 1 . 3a . the notified body shall make available the list of its personnel and their expertise to the commission and , upon request , to other parties . that list shall be kept up to date .


### 2 . 4 . notified bodies shall have available personnel with clinical expertise . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : - identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts ; - appropriately train external clinical experts in the relevant requirements of this regulation , delegated and / or implementing acts , harmonised standards , cts and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided ; - be able to discuss the clinical data contained within the manufacturer ' s clinical evaluation with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation ; - be able to scientifically challenge the clinical data presented , and the results of the external clinical experts ' assessment of the manufacturer ' s clinical evaluation ; - be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts ; - be able to make an objective clinical judgement about the assessment of the manufacturer ' s clinical evaluation and make a recommendation to the notified body ' s decision maker . ### 2 . 4 . clinical experts : notified bodies shall have available , on a permanent basis , personnel with expertise in clinical investigation design , medical statistics , clinical patient management , good clinical practice in the field of clinical investigations and pharmacology . this personnel shall be integrated in the notified body ' s decision - making process in a steady way in order to : - identify when specialist input is required for the assessment of the clinical investigation plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts ; - appropriately train external clinical experts in the relevant requirements of this regulation , delegated and / or implementing acts , harmonised standards , cts and guidance documents and ensure that the external clinical experts are fully aware of the context and implication of their assessment and advice provided ; - be able to discuss the rationale of the planned study design , the clinical investigation plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation ; - be able to scientifically challenge the clinical investigation plans and the clinical data presented , and the results of the external clinical experts ' assessment of the manufacturer ' s clinical evaluation ; - be able to ascertain the comparability and consistency of the clinical assessments conducted by clinical experts ; - be able to make an objective clinical judgement about the assessment of the manufacturer ' s clinical evaluation and make a recommendation to the notified body ' s decision maker . - provide an understanding of active substances .


### invasive laser equipment intended to be used on the human body ; ### laser equipment intended to be used on the human body ;


### summary of safety and clinical performance in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 . ### safety and clinical performance report in the case of devices submitted for marketing authorisation procedure , other than custom - made or investigational devices , the manufacturer shall draw up a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation . the manufacturer shall also draw up a summary of that report which shall be written in a way that is easy for a lay person to understand . the draft of this report shall be part of the documentation to be submitted to and validated by the national authority or the agency , as relevant , involved in the marketing authorisation procedure . . 1a . the summary referred to in paragraph 1 shall be made available to the public via eudamed in accordance with provisions under article 27 and annex v , part a , point 18 . 2 . the commission may , by means of implementing acts , set out the form and the presentation of the data elements to be included in both the report and the summary referred to in paragraph 1 . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 .


### the member states shall take all appropriate measures to encourage healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . the manufacturer shall ensure the appropriate follow - up . the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . ### the member states shall take all appropriate measures , including targeted information campaigns , to encourage and enable healthcare professionals , users and patients to report to their competent authorities suspected serious incidents referred to in point of paragraph 1 . they shall inform the commission of those measures . the competent authorities of the member states shall record such reports centrally at national level . where a competent authority of a member state obtains such reports , it shall inform the manufacturer of the device concerned without delay . the manufacturer shall ensure the appropriate follow - up . where a competent authority of a member state ascertains that the reports received pursuant to the first subparagraph relate to a serious incident it shall notify those reports to the electronic system referred to in article 62 without delay , unless the same incident has already been reported by the manufacturer . the commission , in cooperation with the member states and in consultation with relevant partners including patient and consumer organisations , shall develop standard forms for electronic and non - electronic reporting of serious incidents by healthcare professionals , users and patients .


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


### the data shall be entered into eudamed by the member states , notified bodies , economic operators and sponsors as specified in the provisions concerning the electronic systems referred to in paragraph 2 . ### the data shall be entered into eudamed by the agency , the member states , notified bodies , economic operators , sponsors and healthcare professionals as specified in the provisions concerning the electronic systems referred to in paragraph 2 .


### provisional duties may be imposed if : proceedings have been initiated in accordance with article 10 ; a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with the second subparagraph of article 10 ; a provisional affirmative determination has been made that the imported product benefits from countervailable subsidies and of consequent injury to the community industry ; and the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ### in article 12 , the first and second subparagraph shall be replaced by the following : provisional duties shall be imposed if : proceedings have been initiated in accordance with article 10 ; a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with the second subparagraph of article 10 ; a provisional affirmative determination has been made that the imported product benefits from countervailable subsidies and of consequent injury to the community industry ; and the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings .


### ’’the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ### in article 12 , the second sub - paragraph is replaced by the following : ‘ the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings . ’


### provisional duties may be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the community industry , and if the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ### article 7 shall be replaced by the following : provisional duties shall be imposed if proceedings have been initiated in accordance with article 5 , if a notice has been given to that effect and interested parties have been given adequate opportunities to submit information and make comments in accordance with article 5 , if a provisional affirmative determination has been made of dumping and consequent injury to the community industry , and if the community interest calls for intervention to prevent such injury . the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings .


### ' the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than nine months from the initiation of the proceedings . ' ### article 12 , subparagraph 2 shall be replaced by the following : ' the provisional duties shall be imposed no earlier than 60 days from the initiation of the proceedings but no later than six months from the initiation of the proceedings . '


### this regulation shall enter into force on the day following that of its publication in the official journal of the european union . it shall apply on 1 january 2014 . this regulation shall be binding in its entirety and directly applicable in all member states . ### this regulation shall enter into force on the day following that of its publication in the official journal of the european union . it shall apply on 1 january 2016 . this regulation shall be binding in its entirety and directly applicable in all member states .


### the delegation of power referred to in article 2a shall be conferred on the commission for an indeterminate period of time from the entry into force of this regulation . ### the delegation of power referred to in article 2a shall be conferred on the commission for a period of five years from . . . * . the commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five - year period . the delegation of power shall be tacitly extended for periods of an identical duration , unless the european parliament or the council opposes such extension not later than three months before the end of each period . __________ * oj : please insert the date of entry into force of this regulation .


### 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 teu , articles 8 , 10 , 18 and 19 tfeu and article 21 of the charter , the union should take effective action to combat discrimination based on any grounds such as sex , gender identity , racial or ethnic origin , language , nationality or membership of a national minority , religion or belief , disability , age or sexual orientation and ensure equality between women and men , as well as the protection of the rights of persons with disabilities as an obligation derived from the accession of the union to the un convention on the rights of persons with disabilities . mainstreaming equality and building an inclusive society by combating all forms of discrimination , intolerance and hatred , promoting tolerant and inclusive workplaces and recognising the rights of all to be treated with dignity within the workplace and society in general are ongoing goals which require coordinated action , including by the allocation of sufficient funding . pursuant to articles 2 and 3 teu and article 8 tfeu , equality between women and men is a fundamental value and objective of the eu and the eu should promote gender equality in all its activities . equality between women and men is also enshrined in article 23 of the charter of fundamental rights of the european union . promoting gender equality across the eu is done through a dual approach of specific actions and effective gender mainstreaming in both policies and budgetary allocations .


### non - discrimination 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 should combat discrimination on any grounds , in particular sex , racial or ethnic origin , language , nationality or membership of a national minority , religion or belief , disability , age or sexual orientation and ensure equality between women and men , as well as the protection of the rights of persons with disabilities , which is an obligation derived from the accession of the union to the un convention on the rights of persons with disabilities . 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 .


### to promote the effective implementation of the principles of non discrimination on the grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , including equality between women and men and the rights of persons with disabilities and of the elderly ; ### to promote equal treatment and the effective implementation of the principles of non discrimination on any grounds such as sex , gender identit , racial or ethnic origin , religion or belief , disability , age , sexual orientation , including equality between women and men and the rights of persons with disabilities and of the elderly , recognising the rights of all persons to be treated with dignity ; to combat bullying harassment and intolerant treatment , especially in the workplace ; to abolish discrimination based on nationality between workers from different member states especially as regards employment , remuneration and working conditions ;


### 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 equality , rights and citizenship programme


### 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 whose activities contribute to the implementation of the objectives of the programme , such as support for member states when implementing union law and policies ; support with action grants and operating grants for key european organisations and networks ; support actions and networking activities of cross - border nature ; funding of experts ' networks ; funding of european level observatories .


### 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 and their right to petition the european parliament . 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 any discrimination , no matter where in the union they happen to be .


### 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 . ### to measure the achievement of the objectives set out in paragraph 1 quantitative and qualitative data shall be collected on the respect , exercise and implementation of these rights and the number of complaints .


### 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 , the equality between women and men , tackling all forms of discrimination and inequalities , protecting the rights of persons with disabilities and promoting citizenship contribute to the promotion of the specific objectives and flagship initiatives of the europe 2020 strategy .


### to promote the effective implementation of the principles of non discrimination on the grounds of sex , racial or ethnic origin , religion or belief , disability , age or sexual orientation , including equality between women and men and the rights of persons with disabilities and of the elderly ; ### to promote and mainstream equality for all and the effective implementation of the principles of non discrimination on any grounds including sex , racial or ethnic origin , language , nationality or membership of a national minority , religion or belief , disability , age and sexual orientation equally ;


### by 31 december 2014 , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 . ### by 31 december 2015 , based on the new world light duty test procedure , the commission shall review the specific emissions targets , modalities and other aspects of this regulation in order to establish the co2 emission targets for new light commercial vehicles for the period beyond 2020 , with the aim of reaching , by the year 2025 , a target within an indicative range of 100 g co2 / km to 115 g co2 / km , unless a lower target is duly justified in the light of the use of low - emission technologies and their uptake by the market . on the basis of this review , which shall include an overall assessment of the impact on the automotive industry and its dependent industries , the commission shall , if appropriate , make a proposal to amend this regulation in a way which is cost - effective and as neutral as possible from the point of view of competition and ensures the achievement of the union ' s long term objectives in combating climate change .


### indicative specific emissions of co2 = 147 + a × ### indicative specific emissions of co2 = 128 + a ×


### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . ### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in the view of this , and given that the existing test cycle does not sufficiently reflect the actual emissions of cars and vans on the road , the swift development of an improved test cycle is crucial . when the current test procedures , set out in annex i to regulation no 443 / 2009 , which establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 , are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles .


### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe but is not yet complete . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles . ### the regulation requires the commission to carry out an impact assessment in order to review the test procedures to reflect adequately the real co2 emissions behaviour of cars . this work is proceeding through the development of a world light duty test procedure in the framework of the united nations economic commission for europe , which should be integrated , as soon as possible after it has been finalised , into union legislation . the commission should consider the need to supplement the wltp by additional provisions when integrating it into union law in order to ensure that test procedures reflect adequately the emissions generated by real driving on the road . in view of this , annex i to regulation no 443 / 2009 establishes emission limits for 2020 as measured according to regulation no 715 / 2007 and annex xii to regulation no 692 / 2008 . when the test procedures are amended , the limits set in annex i should be adjusted to ensure comparable stringency for manufacturers and classes of vehicles .


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : ### providers of internet access services shall not restrict the rights and freedoms of end - users provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to :


### ' specialised service ' means an electronic communications service or any other service that provides the capability to access specific content , applications or services , or a combination thereof , and whose technical characteristics are controlled from end - to - end or provides the capability to send or receive data to or from a determined number of parties or endpoints ; and that is not marketed or widely used as a substitute for internet access service ; ### ' specialised service ' means an electronic communications service or any other service that operates within a closed electronic communications network using the internet protocol , relying on admission control , and that is not used as a substitute for internet access service ; furthermore , its function is different from services that are provided via the public internet .


### “article 26 single european emergency call number member states shall ensure that , in addition to any other national emergency call numbers specified by the national regulatory authorities , all end - users of publicly available telephone services , including users of public pay telephones , are able to call the emergency services free of charge , by using the single european emergency call number &#8220 ; 112&#8221 ; . 2 . member states , in consultation with national regulatory authorities , emergency services and providers , shall ensure that undertakings providing end - users with an electronic communications service for originating national calls to a number or numbers in a national telephone numbering plan provide access to emergency services . 3 . member states shall ensure that calls to the single european emergency call number “112” are appropriately answered and handled in the manner best suited to the national organisation of emergency systems . such calls shall be answered and handled at least as expeditiously and effectively as calls to the national emergency number or numbers , where these continue to be in use . 4 . member states shall ensure that access for disabled end - users to emergency services is equivalent to that enjoyed by other end - users . measures taken to ensure that disabled end - users are able to access emergency services whilst travelling in other member states shall be based to the greatest extent possible on european standards or specifications published in accordance with the provisions of article 17 of directive 2002 / 21 / ec , and they shall not prevent member states from adopting additional requirements in order to pursue the objectives set out in this article . 5 . member states shall ensure that undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority . this shall apply to all calls to the single european emergency call number ' 112 ' . member states may extend this obligation to cover calls to national emergency numbers . competent regulatory authorities shall lay down criteria for the accuracy and reliability of the caller location information provided . 6 . member states shall ensure that citizens are adequately informed about the existence and use of the single european emergency call number ' 112 ' , in particular through initiatives specifically targeting persons travelling between member states . 7 . in order to ensure effective access to “112” services in the member states , the commission , having consulted berec , may adopt technical implementing measures . however , these technical implementing measures shall be adopted without prejudice to , and shall have no impact on , the organisation of emergency services , which remains of the exclusive competence of member states . those measures , designed to amend non - essential elements of this directive by supplementing it , shall be adopted in accordance with the regulatory procedure with scrutiny referred to in article 37 . ' ### article 26 is modified as follows : ' article 26 single european emergency call number member states shall ensure that all end - users of the service referred to in paragraph&#160 ; 2 , including users of public pay telephones and of private telecommunications networks , are able to call the emergency services free of charge and without having to use any means of payment , by using the single european emergency call number ' 112 ' and any national emergency call number specified by member&#160 ; states . 2 . member states , in consultation with national regulatory authorities , emergency services and providers , shall ensure that undertakings providing end - users with an electronic communications service for originating national calls to a number or numbers in a national telephone numbering plan provide access to emergency services . end - users must also be able to reach “112” directly when calling from a private telecommunications network . 3 . member states shall ensure that calls to the single european emergency call number ”112” are appropriately answered and handled in the manner best suited to the national organisation of emergency systems . such calls shall be answered and handled at least as expeditiously and effectively as calls to the national emergency number or numbers , where these continue to be in use . the commission , having consulted the national regulatory authorities and emergency services , must define the compulsory performance indicators applicable to the member states . 4 . member states shall ensure that access for disabled end - users to emergency services is equivalent to that enjoyed by other end - users . measures taken to ensure that disabled end - users are able to access emergency services whilst travelling in other member states shall be based to the greatest extent possible on european standards or specifications published in accordance with the provisions of article 17 of directive 2002 / 21 / ec , and they shall not prevent member states from adopting additional requirements in order to pursue the objectives set out in this article . 5 . member states shall ensure that undertakings concerned make caller location information available free of charge to the authority handling emergency calls as soon as the call reaches that authority . this shall apply to all calls to the single european emergency call number ' 112 ' , including calls from private telecommunications networks and roaming calls . member states may extend this obligation to cover calls to national emergency numbers . by * ) at the latest , berec , having consulted the stakeholders and in close collaboration with the commission , shall set the obligatory criteria for the accuracy and reliability of the caller location information to be provided to the emergency services . the member states must be in compliance with these criteria no later than one year after their publication . the commission must also guarantee by ** ) that the levels of accuracy and reliability of caller location information for a call made to “112” from a gnss - enabled mobile terminal are equivalent to the levels for an ecall call . 6 . member states and the commission shall ensure that citizens are adequately informed about the existence and use of the single european emergency call number “112” , in particular through initiatives specifically targeting persons travelling between member states . the commission shall support and supplement the actions of the member states . 7 . in order to ensure effective access to “112” services in the member states , the commission , having consulted berec , shall adopt technical implementing measures . these measures must , inter alia , enable the deployment of an interoperable , next generation 112 service , including multimedia applications , no later than *** . however , these technical implementing measures shall be adopted without prejudice to , and shall have no impact on , the organisation of emergency services , which remains of the exclusive competence of member states . 7 a . the commission shall maintain a database of e . 164 european emergency service numbers in order to ensure that they can be contacted in one member state from another . __________________ * regulation no xxx / 20xx of the european parliament and of the commission of … laying down measures concerning the european single market for electronic communications and to achieve a connected continent , and amending directives 2002 / 20 / ec , 2002 / 21 / ec and 2002 / 22 / ce and regulations no 1211 : / 2009 and no 531 / 2012 . ** regulation no xxx / 20xx of the european parliament and of the commission of … laying down measures concerning the european single market for electronic communications and to achieve a connected continent , and amending directives 2002 / 20 / ec , 2002 / 21 / ec and 2002 / 22 / ce and regulations no 1211 : / 2009 and no 531 / 2012 . *** regulation no xxx / 20xx of the european parliament and of the commission of … laying down measures concerning the european single market for electronic communications and to achieve a connected continent , and amending directives 2002 / 20 / ec , 2002 / 21 / ec and 2002 / 22 / ce and regulations no 1211 : / 2009 and no 531 / 2012 . ”


### end - users shall be free to access and distribute information and content , run applications and use services of their choice via their internet access service . ### end - users shall the right to access , transfer and distribute information and content , run applications , connect hardware and use services and software of their choice . internet access providers cannot block , discriminate against , impair or degrade , including through price surcharge or preferential treatment , the ability of any end - user to use a service to access , use , send , post , receive or offer any content , application or service of their choice , irrespective of source or target . providers of internet access services may however offer agreements that differentiate according to data volumes and speeds , as long as no discrimination based on the content , application or service themselves , or specific classes thereof , is put in place . providers of internet access services shall not make the prices of these services dependent on the content , applications and services that are offered or used via these internet access services .


### ' 1 . member states shall ensure that , when subscribing to services providing connection to a public communications network and / or publicly available electronic communications services , consumers , and other end - users so requesting , have a right to a contract with an undertaking or undertakings providing such connection and / or services . the contract shall specify in a clear , comprehensive and easily accessible form at least : the identity and address of the undertaking ; the services provided , including in particular , whether or not access to emergency services and caller location information is being provided , and any limitations on the provision of emergency services under article 26 , information on any other conditions limiting access to and / or use of services and applications , where such conditions are permitted under national law in accordance with community law , — the minimum service quality levels offered , namely the time for the initial connection and , where appropriate , other quality of service parameters , as defined by the national regulatory authorities , — information on any procedures put in place by the undertaking to measure and shape traffic so as to avoid filling or overfilling a network link , and information on how those procedures could impact on service quality , — the types of maintenance service offered and customer support services provided , as well as the means of contacting these services , — any restrictions imposed by the provider on the use of terminal equipment supplied ; where an obligation exists under article 25 , the subscriber’s options as to whether or not to include his or her personal data in a directory , and the data concerned ; details of prices and tariffs , the means by which up - to - date information on all applicable tariffs and maintenance charges may be obtained , payment methods offered and any differences in costs due to payment method ; the duration of the contract and the conditions for renewal and termination of services and of the contract , including : any minimum usage or duration required to benefit from promotional terms ; — any charges related to portability of numbers and other identifiers , — any charges due on termination of the contract , including any cost recovery with respect to terminal equipment , any compensation and the refund arrangements which apply if contracted service quality levels are not met ; the means of initiating procedures for the settlement of disputes in accordance with article 34 ; the type of action that might be taken by the provider in reaction to security or integrity incidents or threats and vulnerabilities . member states may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content , and on the means of protection against risks to personal security , privacy and personal data , referred to in article 21 and relevant to the service provided . ' ### article 20c is amended as follows : ' 1 . member states shall ensure that , when subscribing to services providing connection to a public communications network and / or publicly available electronic communications services , consumers , and other end - users so requesting , have a right to a contract with an undertaking or undertakings providing such connection and / or services . the contract shall specify in a clear , comprehensive and easily accessible form at least : the identity , address and contact information of the undertaking and , if different , the address and contact information for any complaints ; the main characteristics of the services provided , in particular : – the specific tariff plan or tariff plans to which the contract applies and , for each such tariff plan , the types of services offered , including the volumes of communications ; – in the case of tariff plans with a pre - set volume of communications , the possibility for consumers to defer any unused volume from the preceding billing period ; – access to emergency services and caller location information for all relevant services offered , any limitations on the provision of emergency services under article 26 , and any changes thereto ; – the minimum service quality levels offered , namely the time for the initial connection and , where appropriate , other quality of service parameters , as defined by the national regulatory authorities ; – the types of after - sales services , maintenance service and customer support services provided , the conditions and charges for these services , as well as the means of contacting these services ; any restrictions imposed by the provider on the use of terminal equipment supplied , including information on unlocking the terminal equipment and any charges involved if the contract is terminated before the end of the minimum contract period ; – on demand , free of charge , and provided that no technical incompatibility has been identified , the technical information necessary for the end - user to ensure the proper functioning of his or her chosen terminal equipment for all the services foreseen in his or her contract ; where an obligation exists under article 25 , the subscriber’s options as to whether or not to include his or her personal data in a directory , and the data concerned ; details of prices and tariffs , including taxes and additional charges that may possibly be levied , the means by which up - to - date information on all applicable tariffs and maintenance charges may be obtained ; payment methods offered and any differences in costs due to payment method , and available facilities to safeguard bill transparency and monitor the level of consumption ; the duration of the contract and the conditions for renewal and termination of services and of the contract , including : – any minimum usage or duration required to benefit from promotional terms ; – any charges related to switching and portability of numbers and other identifiers , including compensation arrangements for delay or abuse of switching ; – any charges due on early termination of the contract , including any cost recovery with respect to terminal equipment and other promotional advantages ; any compensation and the refund arrangements , including , where applicable , an explicit reference to statutory rights of the consumer which apply if contracted service quality levels are not met ; the means of initiating procedures for the settlement of disputes , including cross - border disputes , in accordance with article 34 ; details on how disabled end - users can obtain information on products and services designed for them ; the type of action that might be taken by the provider in reaction to security or integrity incidents or threats and vulnerabilities . member states may also require that the contract include any information which may be provided by the relevant public authorities for this purpose on the use of electronic communications networks and services to engage in unlawful activities or to disseminate harmful content , and on the means of protection against risks to personal security , privacy and personal data , referred to in article 21 and relevant to the service provided . '


### end - users shall be free to access and distribute information and content , run applications and use services of their choice via their internet access service . ### open internet access shall be fully guaranteed in accordance with article 2 , so as to enable end - users to access and distribute any information and content they choose , run applications and use services and terminal devices of their choice via their open internet access service , irrespective of the source or destination of such information , content , applications or services . access network operators shall be subject to a general forwarding obligation in accordance with the best effort principle .


### end - users shall also be free to agree with either providers of electronic communications to the public or with providers of content , applications and services on the provision of specialised services with an enhanced quality of service . ### end - users shall also have the right to agree with either providers of electronic communications to the public or with providers of content , applications and services on the provision of specialised services with an enhanced quality of service .


### within the limits of any contractually agreed data volumes or speeds for internet access services , providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by blocking , slowing down , degrading or discriminating against specific content , applications or services , or specific classes thereof , except in cases where it is necessary to apply reasonable traffic management measures . reasonable traffic management measures shall be transparent , non - discriminatory , proportionate and necessary to : implement a legislative provision or a court order , or prevent or impede serious crimes ; b ) preserve the integrity and security of the network , services provided via this network , and the end - users ' terminals ; c ) prevent the transmission of unsolicited communications to end - users who have given their prior consent to such restrictive measures ; d ) minimise the effects of temporary or exceptional network congestion provided that equivalent types of traffic are treated equally . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this paragraph . ### providers of internet access services shall not restrict the freedoms provided for in paragraph 1 by discriminating against , restricting , or otherwise interfering with the transmission of internet traffic except in cases where it is necessary to apply reasonable traffic management measures or to implement a court order . such measures shall be set by transparent procedures , not be maintained longer than strictly necessary and provide adequate safeguards ; in particular to ensure that any restrictions are limited to what is necessary , non - discriminatory and proportionate . those safeguards shall be subject to periodic review and include the possibility of judicial redress . reasonable traffic management shall only entail processing of data that is necessary and proportionate to achieve the purposes set out in this article .


### implement a legislative provision or a court order , or prevent or impede serious crimes ; ### implement a legislative provision or a court order ;