### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ‘ fin - to - carcass’ ratio is established , however , following processing operations , fins and bodies can be landed in different ports . in such cases the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g ; species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation measures , is hampered . ### regulation no 1185 / 2003 allows member states to issue special fishing permits allowing processing on board , whereby shark fins can be removed from the bodies . in order to ensure the correspondence between the weight of fins and bodies , a ' fin - to - carcass ' ratio is established . however , the ratio is theoretical , because it is based on the weight ratio of shark fins to whole sharks , while sharks are usually landed ' dressed ' . therefore , shark fins and carcasses cannot be directly compared against the ratio , and monitoring must rely on species - specific conversion factors , complicating enforcement . the ratio is also higher than the average fin - to - carcass weight for some species . furthermore , following processing operations , fins and bodies can be landed in different ports . for these reasons , the use of the ratio becomes ineffective and gives scope for shark finning to occur . under these circumstances , the collection of data , e . g . species identification , populations structure , underpinning scientific advice for the establishment of fisheries conservation and management measures , as well as the enforcement of the regulation and punishment for non - compliance , are hampered .


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


### patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls . ### patients who are implanted with a device must be given clear and easily accessible essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls .


### where no harmonised standards exist or where relevant harmonised standards are not sufficient , the commission shall be empowered to adopt common technical specifications in respect of the general safety and performance requirements set out in annex i , the technical documentation set out in annex ii or the clinical evaluation and post - market clinical follow - up set out in annex xiii . the cts shall be adopted by means of implementing acts in accordance with the examination procedure referred to in article 88 . ### where no harmonised standards exist or where there is a need to address public health concerns , the commission shall be empowered to adopt common technical specifications in respect of the general safety and performance requirements set out in annex i , the technical documentation set out in annex ii or the clinical evaluation and post - market clinical follow - up set out in annex xiii . the cts shall be adopted by means of implementing acts in accordance with the examination procedure referred to in article 88 .


### the commission may , at the request of a member state , on its own initiative , by means of implementing acts , decide on the application of the classification criteria set out in annex vii to a given device , or category or group of devices , with a view to determining their classification . ### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , decide on the application of the classification criteria set out in annex vii to a given device , or category or group of devices , with a view to determining their classification . such decision should in particular be taken in order to resolve diverging decisions between member states .


### 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 information which shall be submitted to the healthcare professional implanting the device who will be responsible for : - submitting this information to the patient ; and - recording this information in the patient ' s medical records .


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


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


### member states may notify only conformity assessment bodies which satisfy the requirements set out in annex vi . ### member states may notify only conformity assessment bodies which satisfy the requirements set out in annex vi and which have successfully passed an initial assessment performed by the joint assessment team according to article 32 .


### in the case of implantable devices and devices falling within class iii , clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone . demonstration of equivalence in accordance with section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph . ### in the case of implantable devices and devices falling within class iii , clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone . for novel products , demonstration of equivalence in accordance with section 4 shall not be considered as sufficient justification within the meaning of the first sentence of this paragraph . however , for iteration of devices already on the market and for which clinical data are available and for which the data from the post - market surveillance are not indicating any safety concerns , demonstration of equivalence may be considered as a sufficient justification . for devices submitted to the scientific assessment foreseen in this regulation , demonstration of equivalence shall be assessed by the mdcg .


### where the member state has not notified the sponsor according to paragraph 2 within three days following receipt of the comments or of the completed application , the clinical investigation shall be considered as falling within the scope of this regulation and the application shall be considered complete . ### where the member state has not notified the sponsor according to paragraph 2 within six days following receipt of the comments or of the completed application , the clinical investigation shall be considered as falling within the scope of this regulation and the application shall be considered complete .


### 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 .


### equipment for liposuction ; ### equipment for liposuction and lipolysis ;


### - the product identification procedures drawn up and kept up to date from drawings , specifications or other relevant documents at every stage of manufacture ; ### - the product identification and traceability procedures drawn up and kept up to date from drawings , specifications or other relevant documents at every stage of manufacture ;


### the competent authorities shall perform appropriate checks on the characteristics and performance of devices including , where appropriate , review of documentation and physical or laboratory checks on the basis of adequate samples . they shall take account of established principles regarding risk assessment and risk management , vigilance data and complaints . the competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and , where necessary and justified , enter the premises of economic operators and take the necessary samples of devices . they may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary . ### the competent authorities shall perform appropriate checks on the characteristics and performance of devices including , where appropriate , review of documentation and physical or laboratory checks on the basis of adequate samples . they shall take account of established principles regarding risk assessment and risk management , vigilance data and complaints . the competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and enter the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory . they may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary .


### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission and to the notified bodies . ### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission , to the notified bodies and also to manufacturers where the information pertains to their own product .


### there is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices . in order to ensure a high level of health protection , free movement of goods and legal certainty for manufacturers , it is necessary to introduce a uniform definition for nanomaterials based on commission recommendation 2011 / 696 / eu of 18 october 2011 on the definition of nanomaterial , with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at union and international level . in the design and manufacture of medical devices , the manufacturers should take special care when using nanoparticles that can be released to the human body and those devices should be subject to the most severe conformity assessment procedure . ### there is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices . in order to ensure a high level of health protection , free movement of goods and legal certainty for manufacturers , it is necessary to introduce a uniform definition for nanomaterials based on commission recommendation 2011 / 696 / eu of 18 october 2011 on the definition of nanomaterial , with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at union and international level . in the design and manufacture of medical devices , the manufacturers should take special care when using nanoparticles which are intended to be intentionally released in the human body should be subject to the most severe conformity assessment procedure .


### three years after notification of a notified body , and again every third year thereafter , the assessment to determine whether the notified body still satisfies the requirements set out in annex vi shall be conducted by the national authority responsible for notified bodies of the member state in which the body is established and a joint assessment team designated in accordance with the procedure described in article 32 and . at the request of the commission or of a member state , the mdcg may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body with the requirements set out in annex vi . ### two years after notification of a notified body , and again every second year thereafter , the assessment to determine whether the notified body still satisfies the requirements set out in annex vi shall be conducted by the national authority responsible for notified bodies of the member state in which the body is established and a joint assessment team designated in accordance with the procedure described in article 32 and . at the request of the commission or of a member state , the mdcg may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body with the requirements set out in annex vi .


### 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 . ### 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 , when necessary , as for example when for a same product the decisions taken at national level vary between member states , 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 .


### 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 .


### at least 14 days prior to any decision , the competent authority shall notify the mdcg and the commission of its envisaged decision . ### at least 14 days prior to any decision , the competent authority shall notify the mdcg and the commission of its envisaged decision . the final decision shall be made publically available in the eudamed .


### an article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered a device . ### an article that is intended specifically to replace a part or component of a device and that changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this regulation .


### the sponsor of a clinical investigation shall submit an application to the member state in which the investigation is to be conducted accompanied by the documentation referred to in chapter ii of annex xiv . within six days after receipt of the application , the member state concerned shall notify the sponsor whether the clinical investigation falls within the scope of this regulation and whether the application is complete . ### the sponsor of a clinical investigation shall submit an application to the member state in which the investigation is to be conducted accompanied by the documentation referred to in chapter ii of annex xiv . within 14 days after receipt of the application , the member state concerned shall notify the sponsor whether the clinical performance study falls within the scope of this regulation and whether the application is complete .


### 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 in sterile packaging shall provide in advance to the relevant health professional , together with the device , an implant card which shall be made available to the particular patient who has been implanted with the device . the implanter shall be responsible for making the card available to the patient and entering the data in the relevant database . the following types of implant shall be exempt : stitches , clips , screws , plates and accessories to orthopaedic implants . the commission , by means of implementing acts , shall regularly review and update this list of exempted implants . those implementing acts shall be adopted in accordance with article 88 .


### the traceability of medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase - policy and stock - management by hospitals . ### the traceability of medical devices by means of a unique device identification system based on international guidance should significantly enhance the effectiveness of the post - market safety of medical devices due to improved incident reporting , targeted field safety corrective actions and better monitoring by competent authorities . it should also help to reduce medical errors and to fight against counterfeit devices . use of the udi system should also improve purchase - policy and stock - management by hospitals , wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings .


### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . ### the member states shall coordinate between them the development of standard web - based structured forms for reporting of serious incidents by healthcare professionals , users and patients . the member states shall also provide healthcare professionals , users and patients with another forms for reporting of suspected incidents to national 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 healthcare professionals have full access to the electronic system and that the public have an appropriate level of access to it .


### 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 . ### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates , these substances shall be phased out within 8 years from the entry into force of this regulation , unless no safer alternatives are available . in the case that no safer alternatives exist , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , 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 . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , phthalates should be banned as of 1st january 2020 , 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 substances shall be labelled on the device itself and / or on the packaging for each unit as devices containing substances which are classified as cmrs 1a or 1b or as edcs .


### there is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices . in order to ensure a high level of health protection , free movement of goods and legal certainty for manufacturers , it is necessary to introduce a uniform definition for nanomaterials based on commission recommendation 2011 / 696 / eu of 18 october 2011 on the definition of nanomaterial , with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at union and international level . in the design and manufacture of medical devices , the manufacturers should take special care when using nanoparticles that can be released to the human body and those devices should be subject to the most severe conformity assessment procedure . ### there is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices . in order to ensure a high level of health protection , free movement of goods and legal certainty for manufacturers , it is necessary to introduce a uniform definition for nanomaterials based on commission recommendation 2011 / 696 / eu of 18 october 2011 on the definition of nanomaterial , with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at union and international level . in the design and manufacture of medical devices , the manufacturers should take special care when using nanoparticles which are intended to be intentionally released in the human body and those devices should be subject to the most severe conformity assessment procedure .


### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission and to the notified bodies . ### the information collated and processed by the electronic system shall be accessible to the competent authorities of the member states , to the commission , and without prejudice to the preservation of intellectual property and commercially sensitive information to the notified bodies healthcare professionals and independent medical societies and to manufacturers relating to information about their own devices . the data referred to in points to of article 62 shall not be considered commercially confidential information unless the mdcg issues a contrary opinion .


### 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 . ### the commission may on its own initiative or shall at the request of a member state 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 .


### 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 .


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


### ‘ active device’ means any device , the operation of which depends on a source of electrical energy or any source of power other than that directly generated by gravity and which acts by changing the density of or converting this energy . devices intended to transmit energy , substances or other elements between an active device and the patient , without any significant change , shall not be considered to be active devices . stand alone software shall be considered an active device ; ### ‘ active device’ means any device , the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy . devices intended to transmit energy , substances or other elements between an active device and the patient , without any significant change , shall not be considered to be active devices . stand alone software shall be considered an active device ;


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


### the manufacturer and , where applicable , the importer have complied with the requirements set out in article 24 and article 11 respectively . ### the manufacturer and , where applicable , the importer have complied with the requirements set out in article 11 .


### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without significantly changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states . ### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without significantly changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . when the article is a part of an implantable device , the natural or legal person who makes it available on the market shall cooperate with the manufacturer of the device to ensure its compatibility with the functioning part of the device in order to avoid the replacement of the whole device and its consequences for patient safety . substantiating evidence shall be kept available to the competent authorities of the member states .


### an expert committee , the medical device coordination group , composed of persons designated by the member states based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established to fulfil the tasks conferred on it by this regulation and by regulation [ … / … ] on in vitro diagnostic medical devices , to provide advice to the commission and to assist the commission and the member states in ensuring a harmonised implementation of this regulation . ### an expert committee , the medical device coordination group , composed of persons designated by the member states based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established to fulfil the tasks conferred on it by this regulation and by regulation [ … / … ] on in vitro diagnostic medical devices , to provide advice to the commission and to assist the commission and the member states in ensuring a harmonised implementation of this regulation . that experts committee should be supported by a scientific advisory board composed of expert panels for specific medical disciplines in order to proceed with the assessment of high risk device and provide guidelines and common technical specifications for clinical evaluation .


### ‘ sponsor’ means an individual , company , institution or organisation which takes responsibility for the initiation and management of a clinical investigation ; ### ‘ sponsor’ means an individual , company , institution or organisation which takes responsibility for the initiation and management , conduct or financing of a clinical investigation ;


### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission in respect of the products subject to this regulation that are similar to medical devices but do not necessarily have a medical purpose ; adaptation of the definition of nanomaterial to technical progress and to developments at union and international level ; adaptation to technical progress of the general safety and performance requirements , of the elements to be addressed in the technical documentation , of the minimum content of the eu declaration of conformity and of the certificates issued by notified bodies , of the minimum requirements to be met by notified bodies , of the classification rules , of the conformity assessment procedures , and of the documentation to be submitted for the approval of clinical investigations ; the establishment of the udi system ; the information to be submitted for the registration of medical devices and certain economic operators ; the level and structure of fees for the designation and monitoring of notified bodies ; the publicly available information in respect of clinical investigations ; the adoption of preventive health protection measures at eu level ; and the tasks of and criteria for european union reference laboratories and the level and structure of fees for scientific opinions delivered by them . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council . ### in order to maintain a high level of health and safety , the power to adopt acts in accordance with article 290 tfeu should be delegated to the commission in respect of the products subject to this regulation that are similar to medical devices but do not necessarily have a medical purpose ; adaptation of the definition of nanomaterial to technical progress and to developments at union and international level ; adaptation to technical progress of the general safety and performance requirements , of the elements to be addressed in the technical documentation , of the minimum content of the eu declaration of conformity and of the certificates issued by notified bodies , of the minimum requirements to be met by notified bodies , of the classification rules , of the conformity assessment procedures , and of the documentation to be submitted for the approval of clinical investigations ; the establishment of the udi system ; the information to be submitted for the registration of medical devices and certain economic operators ; the level and structure of fees for the designation and monitoring of notified bodies ; the publicly available information in respect of clinical investigations ; the adoption of preventive health protection measures at eu level ; and the tasks of and criteria for european union reference laboratories and the level and structure of fees for scientific opinions delivered by them . however , basic aspects of this regulation such as general safety and performance requirements , stipulations on technical documentation and the requirements for ce mark certification , as well as any amendments or additions to it , should be provided for only through the ordinary legislative procedure . it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level . the commission , when preparing and drawing up delegated acts , should ensure a simultaneous , timely and appropriate transmission of relevant documents to the european parliament and to the council .


### by way of derogation from directives 90 / 385 / eec and 93 / 42 / eec , conformity assessment bodies which comply with this regulation may be designated and notified before its date of application . notified bodies which are designated and notified in accordance with this regulation may apply the conformity assessment procedures laid down in this regulation and issue certificates in accordance with this regulation before its date of application . ### by way of derogation from directives 90 / 385 / eec and 93 / 42 / eec , conformity assessment bodies which comply with this regulation may be designated and notified before its date of application . notified bodies which are designated and notified in accordance with this regulation may apply the conformity assessment procedures laid down in this regulation and issue certificates in accordance with this regulation before its date of application if it has been ensured that the relevant delegated legal acts and implementing acts have been implemented .


### manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices . the expert knowledge shall be demonstrated by either of the following qualifications : ### manufacturers shall have available within their organisation at least one qualified person who possesses the requisite expertise in the field of medical devices . the requisite expertise shall be demonstrated by either of the following qualifications :


### rules on market surveillance should be included in this regulation to reinforce the rights and obligations of the national competent authorities , to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures . ### rules on market surveillance should be included in this regulation to reinforce the rights and obligations of the national competent authorities , to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures . the commission should clearly define the way these inspections should be conducted in order to ensure a full and harmonized implementation within the union .


### 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 :


### any serious incident in respect of devices made available on the union market ; ### any incident in respect of devices made available on the union market ;


### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without significantly changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states . ### any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re - establish the function of the device without changing its performance or safety characteristics , shall ensure that the article does not adversely affect the safety and performance of the device . substantiating evidence shall be kept available to the competent authorities of the member states .


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


### an article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered a device . ### an article that is intended specifically to replace a part or component of a device and that changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this regulation .


### importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately inform the manufacturer and his authorised representative and , if appropriate , take the necessary corrective action to bring that device into conformity , withdraw or recall it . 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 and , if applicable , the notified body that issued a certificate in accordance with article 45 for the device in question , giving details , in particular , of the non - compliance and of any corrective action taken . ### importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this regulation shall immediately inform the manufacturer , and where applicable his authorised representative and , if appropriate , ensure that the necessary corrective action to bring that device in conformity , withdraw or recall it , is taken and , implement that action . 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 and , if applicable , the notified body that issued a certificate in accordance with article 45 for the device in question , giving details , in particular , of the non - compliance and of any corrective action they have implemented .


### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . ### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . such information shall be publicly available


### the competent authorities shall perform appropriate checks on the characteristics and performance of devices including , where appropriate , review of documentation and physical or laboratory checks on the basis of adequate samples . they shall take account of established principles regarding risk assessment and risk management , vigilance data and complaints . the competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and , where necessary and justified , enter the premises of economic operators and take the necessary samples of devices . they may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary . ### the competent authorities shall perform appropriate checks on the characteristics and performance of devices including , where appropriate , review of documentation and physical or laboratory checks on the basis of adequate samples . they shall take account of established principles regarding risk assessment and risk management , vigilance data and complaints . the competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and enter the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory . they may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary .


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


### 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 . ### 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 . in the interests of legal certainty , clear reasons should be given for such decisions and the manufacturers concerned should be consulted as part of the decision - making process . 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 .


### the documentation shall contain a summary of ### the documentation shall contain all available information concerning :


### findings regarding non - compliance of a body with the requirements set out in annex vi shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application . divergent opinions shall be identified in the assessment report of the national authority responsible . ### findings regarding non - compliance of a body with the requirements set out in annex vi shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application . in the event of a disagreement , a separate opinion drawn up by the assessment team setting out its reservations regarding notification shall be appended to the assessment report of the national authority responsible .


### the commission shall be empowered to adopt delegated acts in accordance with article 89 determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessible to allow interoperability with the eu database for clinical trials on medicinal products for human use set up by regulation no [ … / … ] . article 52 and shall apply . ### the commission shall be empowered to adopt implementing acts in accordance with article 88 determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessible to allow interoperability with the eu database for clinical trials on medicinal products for human use set up by regulation no [ … / … ] . article 52 and shall apply .


### 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 . ### contain , in a concentration of 0 . 1% by mass of the plasticised material or above , phthalates , these substances shall be phased out within 8 years from the entry into force of this regulation , unless no safer alternatives are available . in the case that no safer alternatives exist , the manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements , 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 . if the intended use of such devices includes treatment of children or treatment of pregnant or nursing women , phthalates should be banned as of 1st january 2020 , 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 substances shall be labelled on the device itself and / or on the packaging for each unit as devices containing substances which are classified as cmrs 1a or 1b or as edcs .


### ‘ health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health ; ### ‘ health institution’ means an organisation whose primary purpose is the care or treatment of patients ;


### 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 .


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


### ‘ clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety and performance of the device when used as intended by the manufacturer ; ### ‘ clinical evaluation’ means the assessment and analysis of clinical data pertaining to a device in order to verify the safety , performance and clinical benefits of the device when used as intended by the manufacturer ;


### 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


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


### manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices . the expert knowledge shall be demonstrated by either of the following qualifications : ### manufacturers shall have available within their organisation at least one qualified person who possesses the requisite expertise in the field of medical devices . the requisite expertise shall be demonstrated by either of the following qualifications :


### to allow economic operators , notified bodies , member states and the commission to adapt to the changes introduced by this regulation , it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements to be taken for its proper application . it is particularly important that by the date of application , a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market . ### to allow economic operators , especially smes , to adapt to the changes introduced by this regulation and to ensure its proper application , it is appropriate to provide for a sufficient transitional period for the organisational arrangements to be taken . however , parts of the regulation that affect directly member sates and the commission should be implemented as soon as possible . it is particularly important that by the date of application , a sufficient number of notified bodies are designated in accordance with the new requirements to avoid any shortage of medical devices on the market . also at the date of application , existing notified bodies that handle class iii devices , shall be subject to an application for notification in accordance with article 31 .


### 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 , sterile - packaged device shall make available in advance to the healthcare professional or where relevant , to the particular patient who is going to be implanted with the device , the information to be included in an implant passport or in an implant card .


### where the funds in the account designated in the eapo pursuant to paragraph 1 consist of financial instruments , their value shall be determined by reference to the relevant market rate applicable on the day of implementation . ### where the funds in the account designated in the eapo pursuant to paragraph 1 consist of financial instruments , their value shall be determined by reference to the relevant market rate applicable on the day of implementation . where the funds in the account exceed the amounts specified in the preservation order , the bank shall determine the financial instruments to which the preservation order shall apply .


### 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 is replaced by the following : 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 union industry , and if the union interest calls for intervention to prevent such injury . the provisional duties shall be imposed within seven months of the initiation of the proceedings , or no later than nine months in exceptional circumstances for which evidence is provided and of which the interested parties shall be informed .


### 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 . ### 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 union industry , and if the union interest calls for intervention to prevent such injury . the provisional duties shall be imposed only in the last week of the seven - month period starting from the initiation of the proceedings .


### provisional duties shall not be applied within a period of two weeks after the information is sent to interested parties under article 19a . the provision of such information shall not prejudice any subsequent decision that may be taken by the commission . ### provisional duties shall not be applied to products in the process of transit to the union . products shall be deemed to be in the process of transit to the union if they : left the country of origin before the date on which the draft implementing act is submitted to the advisory committee , pursuant to article 15 , informing of the regulation imposing provisional measures ; are transported from the place of loading in the country of origin to the place of unloading in the union under cover of a valid transport document issued before the date on which the draft implementing act is submitted to the advisory committee , pursuant to article 15 , informing of the regulation imposing provisional measures ; the goods have been shipped to be directly imported and put to consumption without transiting through a custom warehouse ; the transport documents clearly establish that from the outset these merchandise were solely and exclusively destined to the eu ; and arrive to the place of unloading within four weeks of the draft implementing act is submitted to the advisory committee , pursuant to article 15 .


### 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 . ' ### in article 12 , the second subparagraph shall be replaced by the following : ' the provisional duties shall be imposed in the seven - month period starting 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 . '


### provisional duties shall not be applied within a period of two weeks after the information is sent to interested parties under article 29b . the provision of such information shall not prejudice any subsequent decision that may be taken by the commission . ### provisional duties shall not be applied to products in the process of shipment to the union . products shall be deemed to be in the process of shipment to the union if they : left the country of origin before the date on which the regulation imposing provisional measures applies ; and are shipped from the place of loading in the country of origin to the place of unloading in the union under cover of a valid transport document issued before the date on which the regulation imposing provisional measures applies .


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


### support for main actors , such as support for member states when implementing union law and policies ; support for key european level networks whose activities are linked to the implementation of the objectives of the programme ; networking among specialised bodies and organisations , national , regional and local authorities at european level ; funding of experts ' networks ; funding of european level observatories . ### support for main actors , such as support for member states when implementing union law and policies ; support for key european level networks and harmonised services of social value , including those using pan - european numbers , organisations , including ngos , 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 ; establishment and implementation of programmes of assistance to victims and groups at risk in the field of the prevention and the fight against violence ; funding of european level observatories .


### 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


### the communication from the commission on europe 20207 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 discrimination and inequalities , notably in the labour market with a view of implementing the principle of equal treatment , 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 .


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


### 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 the effective implementation of the principles of non discrimination on the grounds in particular of sex , racial or ethnic origin , language , membership of a national minority , 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 ;


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


### 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 .


### 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 ;


### this regulation establishes the european union programme on rights and citizenship , hereinafter referred to as ' the programme ' . ### this regulation establishes the european union programme on equality , rights and citizenship , hereinafter referred to as ' the programme ' .


### 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 .


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


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


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed and that the commission comes up with a proposal for targets beyond 2020 before the expiration of this regulation . in order to guarantee planning security , such a proposal shall not take place before 2018 , since the implementation of such targets shall be based on a new test cycle and the relevant test procedures , to be applied for the purpose of measuring specific co2 emissions and for monitoring the target only after 2020 .


### 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 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 . the aim of this review shall be to set an average emissions target for the fleet of new light vehicles for the period after 2025 which falls within a range of 100 to 115 g co2 / km . on the basis of this review , which shall include an overall assessment of the impact on the car 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 .


### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation should be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction in line with the union ' s long term climate goals and the implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . ### to enable the automotive industry to carry out long - term investments and innovation it is desirable to provide indications of how this regulation can be amended for the period beyond 2020 . these indications should be based on an assessment of the necessary rate of reduction and its implications for the development of cost effective co2 reducing technology for cars . it is therefore desirable for these aspects to be reviewed , the commission to make a report and if appropriate proposals made for targets beyond 2020 . the eu ' s long - term reduction targets are conditional on the conclusion of a global agreement on reducing greenhouse gas emissions .


### 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 . in order to enable the provision of specialised services to end - users , providers of content , applications and services and providers of electronic communications to the public shall be free to enter into agreements with each other to transmit the related data volumes or traffic as specialised services with a defined quality of service or dedicated capacity . the provision of specialised services shall not impair in a recurring or continuous manner the general quality of internet access services . ### national regulatory authorities shall ensure that end - users are free to enjoy specialised services delivered by providers of electronic communications services or providers of content , applications and services . providers of electronic communication services or providers of content , applications and services shall be allowed to offer specialised services in addition to internet access services , provided that such offers are not to the detriment of internet access services , or their performance , affordability , or quality .


### the exercise of the freedoms provided for in paragraphs 1 and 2 shall be facilitated by the provision of complete information in accordance with article 25 , article 26 , and article 27 and . ### end - users shall be provided with complete information in accordance with article 20 , article 21 and article 21a of directive 2002 / 22 / ec , including information on any reasonable traffic management measures applied that might affect access to and distribution of information , content , applications and services as specified in paragraphs 1 and 2 .


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


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