### the composition of the eit bodies should be simplified . the functioning of the eit governing board should be streamlined and the respective roles and tasks of the governing board and the director should be further clarified . ### the composition of the eit bodies should be simplified . the functioning of the eit governing board should be streamlined and the respective roles and tasks of the governing board and the director should be further clarified . the governing board and the director must act in the interests of the eit in an independent , impartial and transparent way .


### the kics should broaden their educational activities , by providing professional training courses . ### the kics should broaden their educational activities , by providing professional and summer training courses , distance learning courses and internships . the eit should invest in cultivating a world - class eit brand - name in the area of innovative entrepreneurial education .


### cooperation on the organisation the monitoring and evaluations of the kics between the commission and the eit is required to ensure coherence with overall eu level monitoring and evaluation system . ### cooperation on the organisation of the monitoring and evaluations of the kics between the commission and the eit is required to ensure coherence with overall eu level monitoring and evaluation system . cross - kic coordination and cooperation should be exercised by the eit in order to ensure synergies and added - value creation from the multitude of eit partners .


### the eit triennial work programme should take into account the commission ' s opinion concerning the eit ' s specific objectives , as defined in horizon 2020 , and its complementarities with european union policies and instruments . ### the eit triennial work programme should take into account the opinions of the commission , the european parliament and the councilconcerning the eit ' s specific objectives , as defined in horizon 2020 , and its complementarities with european union policies and instruments . these eu institutions should be adequately involved when this programme is established .


### the evaluation of the eit should provide timely input to the evaluation of horizon 2020 in 2017 and 2023 . ### the evaluation of the eit should allow for direct comparisons of performance and key - indicators with relevant horizon 2020 instruments and should provide timely input to the evaluation of horizon 2020 in 2017 and 2023 .


### stakeholder forum means a meeting open to representatives of national and regional authorities , organized interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from across the knowledge triangle . ### stakeholder forum means a platform , involving physical and virtual conferences and events , open to representatives of national and regional authorities , organized interests and individual entities from business , education , and research , associations , civil society and cluster organisations , as well as other interested parties from across the knowledge triangle .


### stakeholder forum means a meeting open to representatives of national and regional authorities , organized interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from across the knowledge triangle . ### stakeholder forum means a meeting open to representatives of national and regional authorities , organized interests and individual entities from business , higher education , and research , cluster organisations , as well as other interested parties from civil society and from across the knowledge triangle .


### “kic added value activities” : means activities carried out by partner organisations contributing to the integration of the knowledge triangle of research , innovation and higher education , including establishment , administrative and coordination activities of the kics . ### “kic added value activities” : means activities carried out by partner organisations contributing to the integration of the knowledge triangle of research , innovation and higher education , including establishment , administrative and coordination activities of the kics and contributing to the overall objectives of eit .


### the eit ' s mission is to contribute to sustainable european economic growth and competitiveness by reinforcing the innovation capacity of the member states and the union . it shall do this by promoting and integrating higher education , research and innovation of the highest standards the eit ' general objectives , specific objectives and result indicators for the period 2014 - 2020 are defined in horizon 2020 ' . ### the eit ' s mission is to contribute to sustainable european economic and social development and competitiveness by reinforcing the innovation and entrepreneurship capacity of the member states and the union . it shall do this by promoting and integrating higher education , research , innovation and entrepreneurship of the highest standards the eit ' general objectives , specific objectives and result indicators for the period 2014 - 2020 are defined in horizon 2020 ' .


### education and training activities at masters and doctoral level , as well as professional training courses , in disciplines with the potential to meet future european socio - economic needs and which promote the development of innovation - related skills , the improvement of managerial and entrepreneurial skills and the mobility of researchers and students ; ### education and training activities at masters and doctoral level , as well as professional training courses , in disciplines with the potential to meet the future needs of the union’s employment market and which promote the development of innovation - related skills , the improvement of managerial and entrepreneurial skills and the mobility of researchers and students ;


### education and training activities at masters and doctoral level , as well as professional training courses , in disciplines with the potential to meet future european socio - economic needs and which promote the development of innovation - related skills , the improvement of managerial and entrepreneurial skills and the mobility of researchers and students ; ### education and training activities at masters and doctoral level , as well as professional training courses , in disciplines with the potential to meet future european socio - economic needs and which expand the eu ' s talent base , promote the development of innovation - related skills , the improvement of managerial and entrepreneurial skills , the attraction and retention of top - talent , and the mobility of researchers and students


### the eit , shall on the basis of key performance indicators and in cooperation with the commission , organise continuous monitoring and periodic external evaluations of the outputs , results and impact of each kic . ### the eit , shall on the basis of key performance indicators and in cooperation with the commission , organise continuous monitoring and periodic external evaluations of the outputs , results and impact of each kic , in a way that will be directly comparable to the contribution of relevant instruments of the rest of the horizon 2020 and which will be published in the yearly eit scoreboard .


### a rolling triennial work programme , based on the sia , once it is adopted , containing a statement of the major priorities and planned initiatives of the eit and the kics , including an estimate of financing needs and sources . it shall also contain appropriate indicators for monitoring the kics and eit activities . the preliminary rolling triennial work programme shall be submitted by the eit to the commission by 31 december each n - 2 . the commission shall deliver an opinion within three months with regard to eit specific objectives as defined in horizon 2020 and its complementarities with union policies and instruments . the eit shall take a due account of the commission opinion , and in case of disagreement justify its position . the final work programme shall be transmitted by the eit to the european parliament , the council , the commission , the european economic and social committee and the committee of the regions for information ; ### a rolling triennial work programme , based on the sia , once it is adopted , containing a statement of the major priorities and planned initiatives of the eit and the kics , including an estimate of financing needs and sources taking into account the financial viability of each kic . it shall also contain appropriate indicators for monitoring the kics and eit activities . the preliminary rolling triennial work programme shall be submitted by the eit to the european parliament , the council and the commission by 31 december each n - 2 . the european parliament , the council and the commission shall deliver an opinion within three months with regard to eit specific objectives as defined in horizon 2020 and its complementarities with union policies and instruments . the eit shall take a due account of these opinions , and in case of disagreement justify its position . the final work programme shall be transmitted by the eit to the european parliament , the council , the commission , the european economic and social committee and the committee of the regions for information ;


### in paragraph 2 , the word ' five ' is replaced by the word ' three ' ; ### paragraph 2 is replaced by the following : ‘ 2 . by june 2011 , and every three years after the entry into force of a new financial framework , the commission , after consulting stakeholders at both european and national level , shall present a report on the evaluation of the activities of the eit and the kics . the report shall assess the criteria for determining the added value of the eit and also assess its impact and the effectiveness , sustainability , efficiency and relevance of the activities pursued and their relationship , consistency and / or complementarity with existing national and community policies to support higher education , research and innovation . ’


### the financial envelope from horizon 2020 for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 is set at eur 3 . 182 , 230 million the annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope . ### the financial envelope for the implementation of this regulation during the period from 1 january 2014 to 31 december 2020 shall be laid down by article 6 of regulation no [ xxx / xxxx ] establishing horizon 2020 - the framework programme for research and innovation . annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework . the eit financial contribution to the kics shall be provided under this financial envelope .


### the commission shall have regard to the balance between higher education , research , innovation and business experience as well as to gender balance and an appreciation of the higher education , research and innovation environments across the union . ### the commission shall have regard to the balance between higher education , research , innovation and business experience and an appreciation of the higher education , research and innovation environments across the union .


### the commission shall have regard to the balance between higher education , research , innovation and business experience as well as to gender balance and an appreciation of the higher education , research and innovation environments across the union . ### the commission shall have regard to the balance between higher education , research , innovation and business experience as well as to gender balance and the widening participation of the higher education , research and innovation environments across the union .


### the commission shall appoint the member and inform the european parliament and the council about the selection process and the final appointment of those members of the governing board . ### the commission shall appoint the member after informing the european parliament and the council about the selection process and the final appointment of those members of the governing board . before the commission makes any such appointments , parliament and the council may express an opinion concerning the candidates selected .


### the governing board members shall act in the interests of the eit , safeguarding its goals and mission , identity and coherence , in an independent way . ### the governing board members shall act in the interests of the eit , safeguarding its goals and mission , identity and coherence , in an independent way . they shall carry out their duties on an exclusive , full - time basis .


### the governing board members shall act in the interests of the eit , safeguarding its goals and mission , identity and coherence , in an independent way . ### the governing board members shall act in the interests of the eit , safeguarding its goals and mission , identity , autonomy and coherence , in an independent , transparent and impartial way .


### decide on eit’s language regime , taking into account the existing principles on multilingualism and the practical requirements of its operations ; ### ensure the eit complies with the existing principles on multilingualism ;


### decide on eit’s language regime , taking into account the existing principles on multilingualism and the practical requirements of its operations ; ### decide on eit’s language regime , taking into account the existing legislation and principles on multilingualism ;


### promote the eit globally , so as to raise its attractiveness and make it a world - class body for excellence in higher education , research and innovation . ### promote the eit globally , so as to raise its scientific , academic and in particular business attractiveness and make it a world - class body for excellence in higher education , research and innovation .


### the financial means referred to in paragraphs 1 , 2 and 3 of this article shall principally be used in order to repay depositors pursuant to this directive . ### the financial means referred to in paragraphs 1 , 2 and 3 of this article shall principally be used in order to protect and repay depositors pursuant to this directive .


### they may however also be used in order to finance the transfer of deposits to another credit institution , provided that the costs borne by the deposit guarantee scheme do not exceed the amount of covered deposits at the credit institution concerned . in this case , the deposit guarantee scheme shall , within one month from the transfer of deposits , submit a report to the european banking authority proving that the limit referred to above was not exceeded . ### they may however also be used in order to finance the transfer of deposits to another credit institution , provided that the costs borne by the deposit guarantee scheme do not exceed the amount of covered deposits at the credit institution concerned . in this case , the deposit guarantee scheme shall , within one month from the transfer of deposits , submit a report to the relevant national banking authority proving that the limit referred to above was not exceeded .


### member states may allow deposit guarantee schemes to use their financial means in order to avoid a bank failure without being restricted to financing the transfer of deposits to another credit institution , provided that the following conditions are met : ### guarantee schemes may use their financial means also in order to avoid a bank failure without being restricted to financing the transfer of deposits to another credit institution , provided that the guarantee schemes intended to monitor the risk situation of their members can bring sufficient influence to bear and have adequate alternative financing arrangements in place to enable them to obtain short - term funding where necessary to meet claims against them .


### the other deposit guarantee schemes shall act as lending schemes . for this purpose , member states in which more than one scheme is established shall designate one scheme acting as the lending scheme of this member state and inform the european banking authority thereof . member states may decide if and how the lending scheme is reimbursed by other deposit guarantee schemes established in the same member state . ### the other deposit guarantee schemes shall act as lending schemes . for this purpose , member states in which more than one scheme is established shall designate one scheme acting as the lending scheme of this member state and inform the european banking authority thereof . member states may decide if and how the lending scheme is reimbursed by other deposit guarantee schemes established in the same member state . in cases where the national schemes do not reach agreement on the designation of one of them as the lending scheme of the member state concerned , the european banking authority shall make the designation based on the creditworthiness of the individual systems .


### the contributions to deposit guarantee schemes referred to in article 9 shall be determined for each member on the basis of the degree of risk incurred by it . credit institutions shall not pay less than 75% or more than 200% of the amount that a bank with an average risk would have to contribute . member states may decide that members of schemes referred to in article 1 and pay lower contributions to deposit guarantee schemes but not less than 37 . 5% of the amount that a bank with an average risk would have to contribute . ### the contributions to deposit guarantee schemes referred to in article 9 shall be determined for each member on the basis of the degree of risk incurred by it . credit institutions shall not pay less than 75% or more than 200% of the amount that a bank with an average risk would have to contribute . member states may decide that members of schemes referred to in article 1 and pay lower contributions to deposit guarantee schemes but not less than 37 . 5% of the amount that a bank with an average risk would have to contribute , or 20% for deposits with mortgage banks .


### the responsible deposit guarantee scheme is [ insert name and address , telephone , e - mail and web site ] . it will repay your deposits within six weeks at the latest , from 31 december 2013 within one week . ### the responsible deposit guarantee scheme is [ insert name and address , telephone , e - mail and web site ] . it will repay your deposits within six weeks at the latest , from 31 december 2013 within four weeks .


### 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 .


### 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 .


### the findings of the scientific committee on emerging and newly identified health risks , established by commission decision 2008 / 721 / ec of 5 august 2008 setting up an advisory structure of scientific committees and experts in the field of consumer safety , public health and the environment and repealing decision 2004 / 210 / ec , in its scientific opinion of 15 april 2010 on the safety of reprocessed medical devices marketed for single - use , and of the commission in its report of 27 august 2010 to the european parliament and the council on the issue of reprocessing of medical devices in the european union , in accordance with article 12a of directive 93 / 42 / eec , call for regulation of the reprocessing of single - use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions . by reprocessing a single - use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device . ### the findings of the scientific committee on emerging and newly identified health risks , established by commission decision 2008 / 721 / ec of 5 august 2008 setting up an advisory structure of scientific committees and experts in the field of consumer safety , public health and the environment and repealing decision 2004 / 210 / ec , in its scientific opinion of 15 april 2010 on the safety of reprocessed medical devices marketed for single - use , and of the commission in its report of 27 august 2010 to the european parliament and the council on the issue of reprocessing of medical devices in the european union , in accordance with article 12a of directive 93 / 42 / eec , call for regulation of the reprocessing of single - use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions . by reprocessing a single - use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device . for more clarity , only ' intended single - use device ' should be reprocessed and not ' single - use device ' . therefore , with regard to reprocessing , ' multiple - use device ' , ' intended single - use device ' and ' single - use device ' should be defined in this regulation and those terms should be distinguished one from another .


### 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 going to be implanted with a device should be given beforehand 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 .


### 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 , and , where possible , the system should be compatible with the other authentication systems already in place in such environments .


### for high risk medical devices , authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right , on scientifically valid grounds , to scrutinise the preliminary assessment conducted by notified bodies , in particular regarding novel devices , devices for which a novel technology is being used , devices belonging to a category of devices with increased serious incident rates , or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices . the process foreseen in this regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body . ### for innovative high risk medical devices , competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right , in absence of common technical specification or guideline for the conduct of clinical evaluation , to assess clinical data and proceed with a scientific assessment in particular regarding novel devices , devices for which a novel technology is being used , devices belonging to a category of devices with increased serious incident rates , or devices for which significant discrepancies in the conformity assessments by different notified bodies have been identified in respect of substantially similar devices . the process foreseen in this regulation does not prevent a manufacturer from informing voluntarily a competent authority of his intention to file an application for conformity assessment for a high risk medical device before submitting the application to the notified body .


### 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 .


### 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 .


### 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 of the treaty on the functioning of the european union should be delegated to the commission in respect of the minimum requirements to be met by notified bodies , of the classification rules and of the documentation to be submitted for the approval of clinical performance studies ; 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 performance studies ; 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 , substantial elements of this regulation such as general safety and performance requirements , elements to be addressed in technical documentation , the minimum content of the eu declaration of conformity , amending or supplementing the conformity assessment procedures , should only be amended 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 .


### 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 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 .


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


### ‘ single - use device’ means a device that is intended to be used on an individual patient during a single procedure . the single procedure may involve several uses or prolonged use on the same patient ; ### ' single - use device ' means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse . the single procedure may involve several uses or prolonged use on the same patient ;


### ‘ 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 ;


### 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 .


### 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 . ### 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 .


### manufacturers shall ensure that the device is accompanied by the information to be supplied in accordance with section 19 of annex i in an official union language which can be easily understood by the intended user or patient . the language of the information to be supplied by the manufacturer may be determined by the law of the member state where the device is made available to the user or patient . ### manufacturers shall ensure that the device is accompanied by the instructions and safety information to be supplied in accordance with section 19 of annex i in a language which can be easily understood by the intended user or patient , as determined by the member - state concerned .


### manufacturers shall , in response to a reasoned request from a competent authority , provide it with all the information and documentation necessary to demonstrate the conformity of the device , in an official union language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service . ### manufacturers shall , in response to a reasoned request from a competent authority , provide it with all the information and documentation necessary to demonstrate the conformity of the device , in an official union language which can be easily understood by that authority . they shall cooperate with that authority , at its request , on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service . if a competent authority considers or has reason to believe that a device has caused damages , it shall ensure that the potentially harmed user , the user ' s successor in title , the user ' s health insurance company or other third parties affected by the damage caused to the user may request the information referred to in the first subparagraph from the manufacturer .


### that an authorised representative in accordance with article 9 has been designated by the manufacturer ; ### that the manufacturer is identified and that an authorised representative in accordance with article 9 has been designated by the manufacturer


### 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 .


### single - use devices and their reprocessing ### intended single - use devices and their reprocessing


### any natural or legal person who reprocesses a single - use device to make it suitable for further use within the union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this regulation . ### any natural or legal person who reprocesses an intended single - use device to make it suitable for further use within the union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this regulation .


### only single - use devices that have been placed on the union market in accordance with this regulation , or prior to [ date of application of this regulation ] in accordance with directive 90 / 385 / eec or directive 93 / 42 / eec may be reprocessed . ### only intended single - use devices that have been placed on the union market in accordance with this regulation , or prior to [ date of application of this regulation ] in accordance with directive 90 / 385 / eec or directive 93 / 42 / eec may be reprocessed .


### in the case of reprocessing of single - use devices for critical use , only reprocessing that is considered safe according to the latest scientific evidence may be carried out . ### in the case of reprocessing of intended single - use devices for critical use , only reprocessing that is considered safe according to the latest scientific evidence may be carried out .


### the commission , by means of implementing acts , shall establish and regularly update a list of categories or groups of single - use devices for critical use which may be reprocessed in accordance with paragraph 3 . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission , by means of delegated acts , shall establish and regularly update a list of categories or groups of intended single - use devices for critical use which may be reprocessed in accordance with paragraph 3 . those delegated acts shall be adopted in accordance article 89 .


### the name and address of the manufacturer of the original single - use device shall no longer appear on the label , but shall be mentioned in the instructions for use of the reprocessed device . ### the name and address of the manufacturer of the original intended single - use device shall no longer appear on the label , but shall be mentioned in the instructions for use of the reprocessed device .


### the reprocessing of single - use devices and the transfer of single - use devices to another member state or to a third country with a view to their reprocessing ; ### the reprocessing of intended single - use devices and the transfer of intended single - use devices to another member state or to a third country with a view to their reprocessing ;


### the making available of reprocessed single - use devices . ### the making available of reprocessed intended single - use devices .


### 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 .


### 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 is implanted with the device . ### the manufacturer of an implantable 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 .


### 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 . for devices composed of more than one implantable part , it shall also be ensured that the article does not require the replacement of the whole device due to incompatibility with the functioning part of the device . substantiating evidence shall be kept available to the competent authorities of the member states .


### before a device , other than a custom - made or investigational device , is placed on the market the manufacturer or his authorised representative shall submit to the electronic system the information referred to in paragraph 1 . ### before a device , other than a custom - made or investigational device , is placed on the market the manufacturer or his authorised representative shall submit to the electronic system the information referred to in paragraph 1 . it shall be ensured that besides the european registration no national registrations in individual member states can additionally be required .


### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance . it shall be written in a way that is clear to the intended user . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body . ### in the case of devices classified as class iii and implantable devices , other than custom - made or investigational devices , the manufacturer shall draw up a summary of safety and clinical performance and shall update it with the conclusions of the post market clinical follow - up evaluation report referred to in point 3 of part b of annex xiii . it shall be written in a way that is clear to the intended use and in the language of the country where the medical device is made available on the market . the draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with article 42 and shall be validated by that body .


### notified bodies shall satisfy the organisational and general requirements and the quality management , resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this regulation . minimum requirements to be met by notified bodies are set out in annex vi . ### notified bodies shall satisfy the organisational and general requirements and the quality management , resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this regulation . requirements to be met by notified bodies are set out in annex vi .


### 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 and have been awarded a positive recommendation by the mdcg according to article 44a .


### the notification shall clearly specify the scope of the designation indicating the conformity assessment activities , the conformity assessment procedures and the type of devices which the notified body is authorised to assess . ### the notification shall clearly specify the scope of the designation indicating the conformity assessment activities , the conformity assessment procedures , the risk - class and the type of devices which the notified body is authorised to assess .


### the commission may , by means of implementing acts , set up a list of codes and the corresponding types of devices to define the scope of the designation of notified bodies which the member states shall indicate in their notification . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 . ### the commission may , by means of implementing acts , set up a list of codes and the corresponding risk - classes and types of devices to define the scope of the designation of notified bodies which the member states shall indicate in their notification . those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 88 .


### 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 .


### 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 .


### manufacturers of devices classified as class iii , other than custom - made or investigational devices , shall be subject to a conformity assessment based on full quality assurance and design dossier examination as specified in annex viii . alternatively , the manufacturer may choose to apply a conformity assessment based on type examination as specified in annex ix coupled with a conformity assessment based on product conformity verification as specified in annex x . ### manufacturers of devices classified as class iii , other than custom - made or investigational devices , shall be subject to a conformity assessment based on type examination as specified in annex ix coupled with a conformity assessment based on product conformity verification as specified in annex x .


### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application may not be lodged in parallel with more than one notified body for the same conformity assessment activity ### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application shall not be lodged in parallel with more than one notified body for the same conformity assessment activity


### mechanism for scrutiny of certain conformity assessments ### scientific assessment provided by mdcg


### notified bodies shall notify the commission of applications for conformity assessments for devices classified as class iii , with the exception of applications to supplement or renew existing certificates . the notification shall be accompanied by the draft instructions for use referred to in section 19 . 3 of annex i and the draft summary of safety and clinical performance referred to in article 26 . in its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed . the commission shall immediately transmit the notification and the accompanying documents to the mdcg . ### for implantable devices , classified as class iii , the notified body , before delivering the certificate of conformity , shall request a scientific assessment provided by mdcg on the clinical evaluation and the post - market clinical follow - up . notwithstanding subparagraph 1 of article 44 , this requirement shall not apply to devices for which specifications referred to in articles 6 and 7 have been published for the clinical evaluation and the post - market clinical follow - up and devices for which the application for certification only aims at supplementing or renewing existing certificates .


### within 28 days of receipt of the information referred to in paragraph 1 , the mdcg may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate . upon suggestion by any of its members or by the commission , the mdcg shall decide on making such request in accordance with the procedure set out in article 78 . in its request the mdcg shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment . when selecting a specific file for submission , the principle of equal treatment shall be duly taken into account . ### the mdcg shall communicate the result of its scientific assessment at the latest 45 days after submission of the clinical evaluation report as referred to in part a of annex xiii , including the results of clinical investigations as referred to in annex xiv ; the post - market clinical follow - up referred to in part b of annex xiii ; the draft instructions for use referred to in section 19 . 3 of annex i and the draft summary of safety and clinical performance referred to in article 26 and the technical documentation related to annex xiii . within that time period and at the latest 45 days after submission of those documents , the mdcg may request the submission of additional information necessary for the scientific assessment . until the submission of additional information , that time period of 45 days shall be suspended . subsequent requests of mdgc for additional information shall not suspend the period for mdcg scientific assessment .


### the mdcg may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary . within that period and at the latest 30 days after submission , the mdcg may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body ' s preliminary conformity assessment . this may include a request for samples or an on - site visit to the manufacturer ' s premises . until submission of the additional information requested , the period for comments referred to in the first sentence of this subparagraph shall be suspended . subsequent requests for additional information from the mdcg shall not suspend the period for the submission of comments . ### the mdcg scientific assessment is based on an assessment of the dossier by the scientific advisory board referred to in article 80a . if for a device concerned , the manufacturer requested a scientific advice following the procedure referred to in article 82a , the outcome of that procedure shall be submitted together with the notification or as soon as that procedure is completed . the scientific advice shall be duly taken into account by the mdcg and the commission in the course of the implementation of this article .


### the notified body shall give due consideration to any comments received in accordance with paragraph 3 . it shall convey to the commission an explanation of how they have been taken into consideration , including any due justification for not following the comments received , and its final decision regarding the conformity assessment in question . the commission shall immediately transmit this information to the mdcg . ### in case of a favourable scientific assessment , the notified body may proceed with the certification . however , if the favourable scientific assessment is dependant on the application of specific measures , the notified body shall issue the certificate of conformity only on the condition that those measures are implemented . in case of unfavourable scientific assessment , the notified body shall not deliver the certificate of conformity . nevertheless , the notified body may submit new information in response to the explanation included in the mdcg scientific assessment . at the request of the manufacturer , the commission shall organise a hearing allowing discussion on the scientific grounds for the unfavourable scientific assessment and any action that the manufacturer may take or data that may be submitted to address the mdcg concerns


### where deemed necessary for the protection of patient safety and public health , the commission , may determine , by means of implementing acts , specific categories or groups of devices , other than devices of class iii , to which paragraphs 1 to 4 shall apply during a predefined period of time . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### where deemed necessary for the protection of patient safety and public health , the commission , may determine , by means of implementing acts , specific devices , categories or groups of devices , other than devices referred to in paragraph 1 to which paragraphs 1 to 4 shall apply during a predefined period of time . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof ; ### technological novelty or new therapeutic use , which can have significant clinical or public health impact ;


### 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 ;


### 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 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 .


### 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 .


### if in the case of reports received in accordance with article 61 the competent authority ascertains that the reports relate to a serious incident it shall notify without delay those reports to the electronic system referred to in article 62 , unless the same incident has already been reported by the manufacturer ### if in the case of reports received in accordance with article 61 the competent authority ascertains that the reports relate to an incident it shall notify without delay those reports to the electronic system referred to in article 62 ,


### 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 .


### to contribute to the scrutiny of certain conformity assessments pursuant to article 44 ; ### to provide a scientific assessment on certain types of medical devices pursuant to article 44 ;


### 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 .


### 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 .


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


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


### minimum requirements to be met by notified bodies ### requirements to be met by notified bodies


### – are intended specifically for use in direct contact with the central nervous system , in which case they are in class iii , ### – are active or implantable devices intended specifically to control , diagnose , monitor or correct a defect of the central nervous system through direct contact with these parts of the body , in which case they are in class iii ,


### – are intended specifically for use in direct contact with the central nervous system , in which case they are in class iii , ### – are active or implantable devices intended specifically for use in direct contact with the central nervous system , in which case they are in class iii ,


### – are spinal disc replacement implants and implantable devices that come into contact with the spinal column , in which case they are in class iii . ### – are spinal disc replacement implants , in which case they are in class iii .


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


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


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


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


### - 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 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 must not be disclosed to the manufacturer . at the time of such inspections , the notified body shall carry out the tests or ask to carry them in order to check that the quality management system is working properly . it shall provide the manufacturer with an inspection report and with a test report .


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


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


### economic operators should be responsible for the compliance of electrical equipment in relation to their respective roles in the supply chain , so as to ensure a high level of protection of public interests , such as health and safety , and the protection of consumers and to guarantee fair competition on the union market . ### economic operators should be responsible for the compliance of electrical equipment in relation to their respective roles in the supply chain , so as to ensure a high level of protection of public interests , such as health and safety , and the protection of consumers , including a high level of protection of vulnerable consumers in those cases where the electrical equipment is not intended for professional use , and to guarantee fair competition on the union market .


### the existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to products presenting a risk to the health and safety of persons or to other aspects of public interest protection . it should also allow market surveillance authorities , in cooperation with the relevant economic operators , to act at an earlier stage in respect of such products . ### the existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to products presenting a risk to the health and safety of persons , including the safety of children , the elderly and persons with disabilities in those cases where the electrical equipment is not intended for professional use , or to other aspects of public interest protection . it should also allow market surveillance authorities , in cooperation with the relevant economic operators , to act at an earlier stage in respect of such products .


### ' placing on the market ' means the first making available of electrical equipment on the union market ; ### ' making available on the market ' means the supply of electrical equipment for distribution , consumption or use on the union market in the course of a commercial activity , whether in return for payment or free of charge ;


### ‘ making available on the market’ means any supply of electrical equipment for distribution , consumption or use on the union market in the course of a commercial activity , whether in return for payment or free of charge ; ### ' placing on the market ' means the first making available of electrical equipment on the union market ;


### ‘ economic operators’ means the manufacturer , the authorised representative , the importer and the distributor ; ### ‘ economic operator’ means a manufacturer , an authorised representative , an importer or a distributor ;


### ‘ harmonised standard’ means harmonised standard as defined in article 2 of regulation no [ . . / . . ] [ on european standardisation ] ; ### ‘ harmonised standard’ means a standard as defined in article 2 of regulation no [ . . / . . ] [ on european standardisation ] ;


### electrical equipment may be made available on the market only if , having been constructed in accordance with good engineering practice in safety matters in force in the union , it does not endanger the safety of persons , domestic animals or property when properly installed and maintained and used in applications for which it was made . ### electrical equipment may be made available on the market only if , having been constructed in accordance with good engineering practice in safety matters in force in the union , it does not endanger the safety of persons , domestic animals or property when properly installed and maintained and used in applications for which it was made or in applications which can be reasonably foreseen .


### supply of electricity ### prohibition of stricter safety requirements for the supply of electricity


### in relation to electrical equipment , the member states shall ensure that stricter safety requirements than those laid down in article m3 and annex i are not imposed by electricity supply bodies for connection to the grid , or for the supply of electricity to users of electrical equipment . ### in relation to electrical equipment , the member states shall ensure that stricter safety requirements than those laid down in article 3 and annex i are not imposed by electricity supply bodies for connection to the grid , or for the supply of electricity to users of electrical equipment .


### when deemed appropriate with regard to the risks presented by electrical equipment , manufacturers shall , to protect the safety of consumers , carry out sample testing of electrical equipment made available on the market , investigate , and , if necessary , keep a register of complaints , of non - conforming electrical equipment and electrical equipment recalls , and shall keep distributors informed of any such monitoring . ### when deemed appropriate with regard to the risks presented by electrical equipment , manufacturers shall , to protect the health and safety of consumers , carry out sample testing of electrical equipment made available on the market , investigate , and , if necessary , keep a register of complaints , of non - conforming electrical equipment and electrical equipment recalls , and shall keep distributors informed of any such monitoring .


### when deemed appropriate with regard to the risks presented by electrical equipment , importers shall , to protect the safety of consumers , carry out sample testing of electrical equipment made available on the market , investigate and , if necessary , keep a register of complaints , of non - conforming electrical equipment and electrical equipment recalls , and shall keep distributors informed of such monitoring . ### when deemed appropriate with regard to the risks presented by electrical equipment , importers shall , to protect the health and safety of consumers , carry out sample testing of electrical equipment made available on the market , investigate and , if necessary , keep a register of complaints , of non - conforming electrical equipment and electrical equipment recalls , and shall keep distributors informed of such monitoring .


### manufacturers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the electrical equipment or , where that is not possible , on its packaging or in a document accompanying the electrical equipment . the address must indicate a single point at which the manufacturer can be contacted . ### manufacturers shall indicate their name , registered trade name or registered trade mark , their web address in a language easily understood by customers and market surveillance authorities , and the address at which they can be contacted on the electrical equipment or , where that is not possible , on its packaging or in a document accompanying the electrical equipment . the address must indicate a single point at which the manufacturer can be contacted .


### manufacturers shall ensure that the electrical equipment is accompanied by safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . ### manufacturers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . such instructions and safety information as well as any labelling shall be clear , understandable and intelligible .


### importers shall ensure that the electrical equipment is accompanied by safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned . ### importers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end - users , as determined by the member state concerned .


### importers shall indicate their name , registered trade name or registered trade mark and the address at which they can be contacted on the electrical equipment or , where that is not possible , on its packaging or in a document accompanying the electrical equipment . ### importers shall indicate their name , registered trade name or registered trade mark , their web address in a language easily understood by customers and market surveillance authorities , and the address at which they can be contacted on the electrical equipment or , where that is not possible , on its packaging or in a document accompanying the electrical equipment .


### before making electrical equipment available on the market distributors shall verify that the electrical equipment bears the ce marking , that it is accompanied by the safety information in a language which can be easily understood by consumers and other end - users in the member state in which the electrical equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and 6 and article 8 . ### before making electrical equipment available on the market distributors shall verify that the electrical equipment bears the ce marking , that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other end - users in the member state in which the electrical equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and 6 and article 8 .


### economic operators shall , on request , identify the following to the market surveillance authorities : ### economic operators shall , on request , specify the following to the market surveillance authorities :


### economic operators shall be able to present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the electrical equipment and for a period of 10 years after they have supplied the electrical equipment . ### economic operators shall present the information referred to in the first paragraph for a period of 10 years after they have been supplied with the electrical equipment and for a period of 10 years after they have supplied the electrical equipment . economic operators shall not be required to update that information after supply is finalised .


### where harmonised standards referred to in article 12 have not been drawn up and published , the member states shall take all appropriate measures to ensure that , for the purposes of making available on the market or free movement as referred to in articles 3 and 4 respectively , their competent administrative authorities shall also regard as complying with article 3 and annex i electrical equipment which complies with the safety provisions of the international electrotechnical commission 2 . the safety provisions referred to in paragraph 1 shall be notified to the member states by the commission . the commission , after consulting the member states , shall state the provisions and in particular the variants which it recommends to be published . ### where harmonised standards referred to in article 12 have not been drawn up and published , the member states shall take all appropriate measures to ensure that , for the purposes of making available on the market or free movement as referred to in articles 3 and 4 respectively , their competent administrative authorities shall also regard as complying with article 3 and annex i electrical equipment which complies with the safety provisions of the international electrotechnical commission which have been published in accordance with paragraphs 2 and 3 of this article . the safety provisions referred to in paragraph 1 shall be notified to the member states by the commission . the commission , after consulting the member states , shall state the provisions and in particular the variants which it recommends to be published .


### the eu declaration of conformity shall have the model structure set out in annex iv of this directive , shall contain the elements specified in the module a as set out in annex iii of this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the electrical equipment is placed or made available . ### the eu declaration of conformity shall have the model structure set out in annex iv of this directive , shall contain the elements specified in the module a as set out in annex iii of this directive and shall be continuously updated . it shall be translated into the language or languages required by the member state in which market the electrical equipment is placed or made available . upon the request of the market surveillance authorities , the economic operator shall provide a copy of the eu declaration of conformity in paper form or by electronic means .


### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of the electrical equipment . ### by drawing up the eu declaration of conformity , the manufacturer shall assume responsibility for the compliance of the electrical equipment with the requirements laid down in this directive .


### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that electrical equipment covered by this directive presents a risk to the safety of persons , domestic animals or property , they shall carry out an evaluation in relation to the electrical equipment concerned covering all the requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities . ### where the market surveillance authorities of one member state have taken action pursuant to article 20 of regulation no 765 / 2008 , or where they have sufficient reason to believe that electrical equipment covered by this directive presents a risk to the health or safety of persons , domestic animals or property , they shall carry out an evaluation in relation to the electrical equipment concerned covering all the relevant requirements laid down in this directive . the relevant economic operators shall cooperate as necessary with the market surveillance authorities .


### failure of the electrical equipment to meet requirements relating to the safety of persons , domestic animals or property ; ### failure of the electrical equipment to meet requirements relating to the health or safety of persons , domestic animals or property ;


### where , within two months of receipt of the information referred to in paragraph 4 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified . ### where , within three months of receipt of the information referred to in paragraph 4 , no objection has been raised by either a member state or the commission in respect of a provisional measure taken by a member state , that measure shall be deemed justified .


### member states shall ensure that appropriate restrictive measures are taken in respect of the electrical equipment concerned without delay . ### member states shall ensure that appropriate restrictive measures are taken in respect of the electrical equipment concerned , such as withdrawal of the electrical equipment from their market , without delay .


### compliant electrical equipment which present a risk to safety ### compliant electrical equipment which present a risk to health and safety


### where , having performed an evaluation under article 19 , a member state finds that although electrical equipment is in compliance with this directive , it presents a risk to the safety of persons , it shall require the relevant economic operator to take all appropriate measures to ensure that the electrical equipment concerned , when placed on the market , no longer presents that risk , to withdraw the electrical equipment from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe . ### where , having performed an evaluation under article 19 , a member state finds that although electrical equipment is in compliance with this directive , it presents a risk to the health or safety of persons and safety of domestic animals and property , it shall require the relevant economic operator to take all appropriate measures to ensure that the electrical equipment concerned , when placed on the market , no longer presents that risk , to withdraw the electrical equipment from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe .


### member states shall lay down rules on penalties for economic operators , applicable to infringements of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . ### member states shall build upon existing mechanisms to ensure correct application of the regime governing the ce marking and shall take appropriate action in the event of improper use of the marking . member states shall lay down rules on penalties applicable to infringements by economic operators of the national provisions adopted pursuant to this directive and shall take all measures necessary to ensure that they are enforced . such rules may include criminal penalties for serious infringements .


### the penalties provided for shall be effective , proportionate and dissuasive . ### the penalties referred to in the first paragraph shall be effective , proportionate to the seriousness of the offence , and dissuasive .


### member states shall notify those provisions to the commission by [ insert date – the date set out in the second subparagraph of article 25 ] at the latest and shall notify it without delay of any subsequent amendment affecting them . ### member states shall notify those provisions to the commission by [ insert date – the date set out in the second subparagraph of article 25 ] and shall notify it without delay of any subsequent amendment affecting them . the commission shall make those provisions publicly available by publishing them on the internet .


### member states shall communicate to the commission the texts of the main provisions of national laws which they adopt in the field covered by this directive . ### member states shall communicate to the commission the texts of the main provisions of national laws which they adopt in the field covered by this directive . the commission shall make those texts publicly available by publishing them on the internet .


### the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the electrical equipment with the technical documentation referred to in point 2 and with the requirements of this directive . ### the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured electrical equipment with the technical documentation referred to in point 2 and with the requirements of this directive .