### the board shall adopt its rules of procedure by unanimous decision containing , inter alia , the decision - making arrangements of the board , the provisions on the appointment and term of office of the chair and vice - chairs of the network . the board shall adopt by majority decision the annual work programme including the setting up of working groups and the language arrangements of the network meetings , and the annual network report that should be published . ### the board shall adopt its rules of procedure by unanimous decision containing , inter alia , the decision - making arrangements of the board , the provisions on the appointment and term of office of the chair and vice - chairs of the network . the board shall adopt by majority decision the annual work programme including the setting up of working groups and the language arrangements of the network meetings , and the annual network report that should be published and sent to parliament and to the council .


### the global resources for the implementation of this decision shall be established within the framework of the programme for social change and innovation , the annual appropriations of which shall be authorised by the budgetary authority within the limits of the financial framework . ### the global resources for the implementation of this decision shall be established within the framework of the programme for employment and innovation , the annual appropriations of which shall be authorised by the budgetary authority within the limits of the financial framework .


### a delegated act adopted pursuant to article 7 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 2 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 2 months at the initiative of the european parliament or the council . ### a delegated act adopted pursuant to article 7 shall enter into force only if no objection has been expressed either by the european parliament or the council within a period of 3 months of notification of that act to the european parliament and the council or if , before the expiry of that period , the european parliament and the council have both informed the commission that they will not object . that period shall be extended by 3 months at the initiative of the european parliament or the council .


### four years after its entry into force , the commission shall submit a report on the application of this decision to the european parliament , the council , the european economic and social committee and the committee of regions . the report shall in particular assess to what extent the network has contributed to the achievement of the objectives set out in article 2 and whether it fulfilled its tasks . ### four years after its entry into force , the commission shall submit a report on the application of this decision to the european parliament , the council , the european economic and social committee and the committee of regions . the report shall in particular assess to what extent the network has contributed to the achievement of the objectives set out in article 2 and whether it fulfilled its tasks . where necessary , the commission shall submit a proposal for a review of this decision .


### the european union and its more than 50 institutions and agencies should be equipped with a high - quality european public administration , so as to enable it to perform its tasks to the highest possible standard in accordance with the treaties and to meet the challenges , both internal and external , that it will face in the future . ### the european union , and its more than 50 institutions and agencies , should continue to be equipped with a high - quality european public administration , so as to enable it to achieve its objectives , implement its policies and activities and perform its tasks to the highest possible standard in accordance with the treaties to meet the challenges , both internal and external , that it will face in the future and to serve the citizens of the union .


### consequently , it is necessary to provide a framework for the recruitment of high calibre staff in terms of productivity and integrity , drawn on the widest possible geographical basis from among citizens of the member states , and to enable such staff to carry out their duties as effectively and efficiently as possible . ### consequently , it is necessary to ensure a framework for attracting , recruiting and maintaining highly - qualified and multilingual staff , drawn on the widest possible geographical basis from among citizens of the member states , independent and adhering to the highest professional standards , and to enable such staff to carry out their duties as effectively and efficiently as possible .


### 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 council , ### the commission , when preparing and drawing - up delegated acts , should ensure a simultaneous , timely and appropriate transmission of all the relevant documents to the european parliament and council ,


### the establishment plan appended to the section of the budget related to each institution shall indicate the number of posts in each grade and function group . each institution ' s establishment plan shall reflect the obligations set out in the multi - annual financial framework and the inter - institutional agreement on its implementation . 2 . without prejudice to the principle of promotion based on merit as laid down in article 45 , this plan shall ensure that for each institution , the number of vacant positions at every grade of the establishment plan on 1 january of each year corresponds to the number of officials in the lower grade in active employment on 1 january of the preceding year , multiplied by the rates laid down in annex i , point b , for that grade . these rates shall be applied on a five - year average basis as from 1 january 2013 . 3 . the rates laid down in annex i , section b , shall be reviewed at the end of a five - year period starting on 1 january 2013 on the basis of a report , submitted by the commission to the european parliament and the council , and a proposal by the commission . the european parliament and the council shall decide in accordance with article 336 of the treaty on the functioning of the european union . 4 . after the same five - year period , the commission shall report to the european parliament and to the council on the implementation of the provisions on the function group ast / sc and of the transitional provisions laid down in article 30 of annex xiii , taking into account the evolution of the need for staff carrying out secretarial and clerical tasks in all institutions and the evolution of permanent and temporary posts in function group ast and of the number of contract agents in function group ii . ### the establishment plan appended to the section of the budget related to each institution shall indicate the number of posts in each grade and function group . 2 . without prejudice to the principle of promotion based on merit as laid down in article 45 , this plan shall ensure that for each institution , the number of vacant positions at every grade of the establishment plan on 1 january of each year corresponds to the number of officials in the lower grade in active employment on 1 january of the preceding year , multiplied by the rates laid down in annex i , point b , for that grade . these rates shall be applied on a five - year average basis as from 1 january 2013 . 3 . the rates laid down in annex i , section b , shall be reviewed at the end of a five - year period starting on 1 january 2013 on the basis of a report , submitted by the commission to the european parliament and the council , and a proposal by the commission . the european parliament and the council shall decide in accordance with article 336 of the treaty on the functioning of the european union . 4 . after the same five - year period , the commission shall report to the european parliament and to the council on the implementation of the provisions on the function group ast / sc and of the transitional provisions laid down in article 30 of annex xiii , taking into account the evolution of the need for staff carrying out secretarial and clerical tasks in all institutions and the evolution of permanent and temporary posts in function groups ast and ast / sc .


### without prejudice to article 29 , officials shall be recruited only at grades sc 1 , ast 1 to ast 4 or ad 5 to ad 8 . ### without prejudice to article 29 , officials shall be recruited only at grades sc 1 to sc 3 , ast 1 to ast 4 or ad 5 to ad 8 .


### unless the procedure laid down in articles 4 and 29 is applied , officials may only be promoted if they occupy a post which corresponds to one of the types of post set out in annex i , section a , for the next higher grade . ### officials of grade ast 9 may be promoted to grade ast 10 only in accordance with the procedure laid down in articles 4 and 29 .


### officials not covered by point who were before 1 may 2004 in the former category b or who were before 1 may 2004 in the former category c or d and have become member of function group ast without restriction shall be classified as assistant . ### officials not covered by point who were before 1 may 2004 in the former category b or who were before 1 may 2004 in the former category c or d and have become members of function group ast without restriction , as well as officials recruited since 1 may 2004 , shall be classified as assistant .


### officials who were authorised , on the basis of article 55 of the staff regulations and article 4 of annex iva to the staff regulations , to work part time for a period starting before 1 january 2013 and extending beyond that date may continue to work part time under the same conditions during a maximum overall period of five years . ### officials who were authorised , on the basis of article 55a of the staff regulations and article 4 of annex iva to the staff regulations , to work part time for a period starting before 1 january 2013 and extending beyond that date may continue to work part time under the same conditions during a maximum overall period of five years .


### the establishment and allocation of fishing opportunities and the fixing of the biological references are measures of prime importance in the common fisheries policy and have a direct impact on the socio - economic situation of the fishing fleets of the member states . it is appropriate that the council should reserve to itself the right to exercise directly implementing powers in relation to these specific matters . ### the establishment and allocation of fishing opportunities and the fixing of the biological references are measures of prime importance in the common fisheries policy and have a direct impact on the socio - economic situation of the fishing fleets of the member states , also needing , in particular , to take account of sales of fresh fish for human consumption from the small - scale coastal fleets directly linked to coastal fishery areas that are highly fisheries - dependent . it is appropriate that the council should reserve to itself the right to exercise directly implementing powers in relation to these specific matters .


### civil - military ssa user requirements were defined in the commission staff working paper ‘ european space situational awareness high - level civil - military user requirements’14 endorsed by the member states in the political and security committee of the council on 18 november 201115 . the provision of sst services should serve only civilian purposes . purely military requirements should not be addressed by this decision . __________________ 14 sec 1247 final , 12 . 10 . 2011 . 15 council document 15715 / 11 , 24 . 10 . 2011 . ### civil - military ssa user requirements were defined in the commission staff working paper ‘ european space situational awareness high - level civil - military user requirements’14 endorsed by the member states in the political and security committee of the council on 18 november 201115 . the provision of sst services should serve both civilian and military purposes . a thorough analysis should be conducted on how eu member states ' military capabilities will benefit from sst services as well as on sst services contribution to safeguard the implementation of the outer space treaty . __________________ 14 sec 1247 final , 12 . 10 . 2011 . 15 council document 15715 / 11 , 24 . 10 . 2011 .


### by 1 july 2018 , the commission shall submit an evaluation report on the implementation of the sst support programme to the european parliament and the council . that report shall include recommendations on the renewal , modification or suspension of the actions supported by the sst support programme taking into account the following : ### each year the commission shall submit an evaluation report on the implementation of the sst support programme to the european parliament and the council . that report shall include recommendations on the renewal , modification or suspension of the actions supported by the sst support programme taking into account the following :


### to support legal migration to the union in line with the economic and social needs of member states and promote the effective integration of third - country nationals , including of asylum seekers and beneficiaries of international protection ; ### to support legal migration to the union in line with the economic and social needs of member states and promote the effective integration of third - country nationals and to strengthen the respect of human rights of migrants , including of asylum seekers and beneficiaries of international protection ;


### to enhance the solidarity and responsibility sharing between the member states , in particular towards those most affected by migration and asylum flows . ### to enhance the solidarity and responsibility sharing between the member states , in particular towards those most affected by migration and asylum flows and to support a constant dialogue with civil society organisations for the development of national programmes .


### fish belonging to the taxon elasmobranchii , which includes sharks , skates , rays and similar species are generally very vulnerable to exploitation due to their life - cycle characteristics of slow growth , late maturity and small number of young . in recent years , some shark populations have been severely targeted and put under serious threat as a result of a dramatic increase in demand for shark products , fins in particular . ### fish belonging to the taxon elasmobranchii , which includes sharks , skates , rays and similar species are generally very vulnerable to exploitation due to their life - cycle characteristics of slow growth , late maturity and small number of young . non - sustainable shark fishing has endangered the balance of marine ecosystems and , in recent years , some shark populations have been severely targeted by vessels flying the flag of a member state or third country in maritime waters under the sovereignty or the jurisdiction of member states or in other maritime waters and put under serious threat as a result of a dramatic increase in demand for shark products , fins in particular . growing demand for shark fin preparations and the high price they fetch have also led to an increase in illegal fishing .


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


### in 1999 the food and agriculture organisation of the united nations adopted the international action plan for the conservation and management of sharks , which was the basis for the 2009 commission communication on a european community action plan for the conservation and management of sharks , whereby the union committed itself to adopt all necessary measures for the conservation of sharks and to minimize waste and discards from shark catches . the council endorsed the overall approach and specific objectives of the union as set out in that communication . ### in 1999 the food and agriculture organisation of the united nations adopted the international action plan for the conservation and management of sharks , which was the basis for the 5 february 2009 commission communication on a european community action plan for the conservation and management of sharks , whereby the union committed itself to adopt all necessary measures for the conservation of sharks and to minimize waste and discards from shark catches . the council endorsed the overall approach and specific objectives of the union as set out in that communication , and encouraged the commission to pay particular attention to the question of the removal of fins and to present as soon as possible amendments to regulation no 1185 / 2003 , notably with reference to the exemptions and the associated conditions laid down therein .


### regional fisheries management organisations are increasingly addressing the issue of shark finning and their scientific bodies are showing preference for the landing of sharks with their fins naturally attached to the body . ### regional fisheries management organisations are increasingly addressing the issue of shark finning and their scientific bodies are showing preference for the landing of sharks with their fins naturally attached to the body . the annual resolutions on sustainable fisheries issued by united nations general assembly since 2007 , the 2008 iucn ' s global policy against shark finning and the 2010 meeting of the fish stocks agreement review conference have called upon nations to take measures to require that all sharks be landed with their fins naturally attached .


### where fishing vessels flying the flag of a member state catch , retain on board , tranship or land sharks , the flag member state shall send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance of vessels with the regulation , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided : ### a member state in which fishing vessels catch , retain on board , tranship or land sharks , and / or a member state in which fishing vessels flying the flag of a third country tranship or land sharks shall send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance of vessels with the regulation , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided , pursuant to council regulation no 1224 / 2009 of 20 november 2009 establishing a community control system for ensuring compliance with the rules of the common fisheries policy1 and to commission implementing regulation no 404 / 2011 of 8 april 2011 laying down detailed rules for the implementation of council regulation no 1224 / 2009 establishing a community control system for ensuring compliance with the rules of the common fisheries policy2 : __________________ 1 oj l 343 , 22 . 12 . 2009 , p . 1 . 2 oj l 112 , 30 . 04 . 11 , p . 1 .


### where fishing vessels flying the flag of a member state catch , retain on board , tranship or land sharks , the flag member state shall send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance of vessels with the regulation , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided : ### where fishing vessels flying the flag of a member state catch , retain on - board , tranship or land sharks , the flag member state shall , in accordance with regulations n&#186 ; 1224 / 2009 establishing a community control system for ensuring compliance with the rules of the common fisheries policy and n&#186 ; 404 / 2011 laying down detailed rules for the implementation of the above regulation , send to the commission , by 1 may at the latest , a comprehensive annual report on the implementation of this regulation during the previous year . the report shall describe the monitoring of compliance with the regulation of vessels in the eu and non - eu waters , and the enforcement measures taken by member states in cases of non - compliance . in particular , the following information shall be provided :


### – the number of inspections carried out ; ### – the number , date and place of inspections carried out ;


### this regulation aims to ensure the functioning of the internal market as regards medical devices , taking as a base a high level of protection of health . at the same time , this regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products . both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other . as regards article 114 tfeu , this regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the union market which may then benefit from the principle of free movement of goods . as regards article 168 tfeu , this regulation sets high standards of quality and safety for those medical devices by ensuring , among other things , that data generated in clinical investigations is reliable and robust and that the safety of the subjects participating in a clinical investigation is protected . ### this regulation aims to ensure the functioning of the internal market as regards medical devices , taking as a base a high level of protection of health for patients , users and operators . at the same time , this regulation sets high standards of quality and safety for medical devices to meet common safety concerns as regards these products . both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other . as regards article 114 tfeu , this regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the union market which may then benefit from the principle of free movement of goods . as regards article 168 tfeu , this regulation sets high standards of quality and safety for those medical devices by ensuring , among other things , that data generated in clinical investigations is reliable and robust and that the safety of the subjects participating in a clinical investigation is protected .


### key elements of the existing regulatory approach , such as the supervision of notified bodies , conformity assessment procedures , clinical investigations and clinical evaluation , vigilance and market surveillance should be significantly reinforced , whilst provisions ensuring transparency and traceability regarding devices should be introduced , to improve health and safety . ### key elements of the existing regulatory approach , such as the supervision of notified bodies , conformity assessment procedures , clinical investigations and clinical evaluation , vigilance and market surveillance should be significantly reinforced , whilst provisions ensuring transparency and traceability regarding devices should be introduced , to improve health and safety for health professionals , patients , users and operators , including in the waste disposal chain .


### key elements of the existing regulatory approach , such as the supervision of notified bodies , conformity assessment procedures , clinical investigations and clinical evaluation , vigilance and market surveillance should be significantly reinforced , whilst provisions ensuring transparency and traceability regarding devices should be introduced , to improve health and safety . ### key elements of the existing regulatory approach , such as the supervision of notified bodies , conformity assessment procedures , clinical investigations and clinical evaluation , vigilance and market surveillance should be significantly reinforced , whilst provisions relating to the marketing authorisation procedure ensuring transparency and traceability regarding devices should be introduced , to improve health and safety .


### like for products that contain viable tissues or cells of human or animal origin , that are explicitly excluded from directives 90 / 385 / eec and 93 / 42 / eec and hence from this regulation , it should be clarified that products that contain living biological substances of other origin are also not covered by this regulation . ### like for products that contain viable tissues or cells of human or animal origin , that are explicitly excluded from directives 90 / 385 / eec and 93 / 42 / eec and hence from this regulation , it should be clarified that products that contain living biological substances of other origin that achieve their intended purpose by pharmacological , immunological or metabolic means are also not covered by this regulation .


### 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 and safety protection for health professionals , operators and patients , as well as free movement of goods , legal certainty for manufacturers and responsibility on their part , 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 .


### to recognise the important role of standardisation in the field of medical devices , compliance with harmonised standards as defined in regulation no [ … / … ] on european standardisation should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements , such as quality and risk management . ### to recognise the important role of standardisation and traceability in the field of medical devices , compliance with harmonised standards as defined in regulation no [ … / … ] on european standardisation should be a means for manufacturers to demonstrate conformity with the general safety and performance requirements and other legal requirements , such as quality and risk management .


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


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


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


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


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


### the proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection and citizens ' confidence in the system . designation and monitoring of notified bodies by the member states , in accordance with detailed and strict criteria , should therefore be subject to controls at union level . ### the proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection for health professionals , users and operators , including in the waste disposal chain , and for ensuring citizens’ confidence in the system . designation and monitoring of notified bodies by the member states , in accordance with detailed and strict criteria , should therefore be subject to controls at union level .


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


### in order to better protect health and safety regarding devices on the market , the vigilance system for medical devices should be made more effective by creating a central portal at union level for reporting serious incidents and field safety corrective actions . ### in order to better protect the health and safety of health professionals , patients , users and operators , including in the waste disposal chain , regarding devices on the market , the vigilance system for medical devices should be made more effective by creating a central portal at union level for reporting serious incidents and field safety corrective actions .


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


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


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


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


### an expert committee , the medical device coordination group , composed of persons designated by the member states based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established 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 . ### a medical device coordination group , composed of persons designated by the member states based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices should be established 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 .


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


### for the purposes of this regulation , medical devices and accessories to medical devices shall hereinafter be referred to as ‘ devices’ . ### for the purposes of this regulation , medical devices , accessories to medical devices and devices for aesthetic purposes shall hereinafter be referred to as ‘ devices’ .


### ‘ accessory to a medical device’ means an article which , whilst not being a medical device , is intended by its manufacturer to be used together with one or several particular medical device to specifically enable or assist the device to be used in accordance with its / their intended purpose ; ### ‘ accessory to a medical device’ means an article which is intended by its manufacturer to be used together with one or several particular medical device to specifically enable or assist the device to be used in accordance with its / their intended purpose ;


### ‘ clinical data’ means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following : ### ‘ clinical data’ means all the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following :


### ‘ 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 a device , as defined in points 1 to 6 of this paragraph , including malfunction , use errors or inadequacy in the information supplied by the manufacturer ;


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


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


### member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto . ### the ultimate responsibility for the notified bodies and the national authority responsible for notified bodies lies with the member state in which they are located . the member state is required to check that the designated national authority responsible for notified bodies performs its work on the assessment , designation and notification of conformity assessment bodies and for the monitoring of the notified bodies properly and that the designated national authority responsible for notified bodies works impartially and objectively . member states shall provide the commission and the other member states with information on their procedures for the assessment , designation and notification of conformity assessment bodies and for the monitoring of notified bodies , and of any changes thereto .


### the national authority responsible for notified bodies shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks . without prejudice to article 33 , where a national authority is responsible for the designation of notified bodies in the field of products other than medical devices , the competent authority for medical devices shall be consulted on all aspects specifically related to medical devices . ### the national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel ' in house ' , for the proper performance of its tasks . compliance with that requirement shall be assessed in the peer - review referred to in paragraph 8 . in particular , the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3 . 2 . 5 . of annex vi . similarly , the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer ' s quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3 . 2 . 6 . of annex vi . where a national authority is responsible for the designation of notified bodies in the field of products other than medical devices , the competent authority for medical devices shall be consulted on all aspects specifically related to medical devices .


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


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


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


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


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


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


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


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


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


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


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


### notified bodies shall respond without delay to requests relating to conformity assessments they have carried out , submitted by their or another member state ' s authority or by the commission . the national authority responsible for notified bodies of the member state in which the body is established shall enforce requests submitted by authorities of any other member state or by the commission unless there is a legitimate reason for not doing so in which case both sides may consult the mdcg . the notified body or their national authority responsible for notified bodies may request that any information transmitted to the authorities of another member state or to the commission shall be treated confidential . ### notified bodies shall respond without delay , and at least within 15 days to requests relating to conformity assessments they have carried out , submitted by their or another member state ' s authority or by the commission . the national authority responsible for notified bodies of the member state in which the body is established shall enforce requests submitted by authorities of any other member state or by the commission . where there is a legitimate reason for not doing so , the notified bodies shall explain these reasons and shall consult the mdcg , which shall then issue a recommendation . the national authority responsible for notified bodies shall comply with the mdcg ' s recommendation .


### the national authority responsible for notified bodies shall immediately inform the commission and the other member states of any suspension , restriction or withdrawal of a notification . ### the national authority responsible for notified bodies shall immediately inform the commission , the other member states and the relevant manufacturers and health professionals of any suspension , restriction or withdrawal of a notification .


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


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


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


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


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


### the commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices , including in vitro diagnostic medical devices . ### the commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices , including in vitro diagnostic medical devices . this group shall meet on a regular basis and at least twice a year .


### the commission shall be empowered to adopt delegated acts in accordance with article 89 setting out the structure and the level of the fees referred to in paragraph 1 , taking into account the objectives of protection of human health and safety , support of innovation and cost - effectiveness . particular attention shall be paid to the interests of notified bodies that submitted a valid certificate delivered by the national accreditation body as referred to in article 31 and notified bodies that are small and medium - sized enterprises as defined by commission recommendation 2003 / 361 / ec . ### the commission shall be empowered to adopt delegated acts in accordance with article 89 setting out the structure and the comparable level of the fees referred to in paragraph 1 , taking into account the objectives of protection of human health and safety , support of innovation cost - effectiveness and the need to create a level - playing field across member states . particular attention shall be paid to the interests of notified bodies that submitted a valid certificate delivered by the national accreditation body as referred to in article 31 and notified bodies that are small and medium - sized enterprises as defined by commission recommendation 2003 / 361 / ec .


### in the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in articles 61 to 75 , the commission shall be empowered to adopt delegated acts in accordance with article 89 as regards the following : ### in the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in articles 61 to 75 , the commission , having consulted relevant stakeholders , including healthcare professionals ' organisations , shall be empowered to adopt delegated acts in accordance with article 89 as regards the following :


### manufacturers of devices classified as class iia , other than custom - made or investigational devices , shall be subject to a conformity assessment based on full quality assurance as specified in annex viii , except for its chapter ii , with assessment of the design documentation within the technical documentation on a representative basis . alternatively , the manufacturer may choose to draw up the technical documentation set out in annex ii coupled with a conformity assessment based on product conformity verification as specified in section 7 of part a or section 8 of part b of annex x . ### by way of derogation from article 41a , manufacturers of devices classified as class iia , other than custom - made or investigational devices , shall be subject to a conformity assessment based on full quality assurance as specified in annex viii , except for its chapter ii , with assessment of the design documentation within the technical documentation on a representative basis . alternatively , the manufacturer may choose to draw up the technical documentation set out in annex ii coupled with a conformity assessment based on product conformity verification as specified in section 7 of part a or section 8 of part b of annex x .


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


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


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


### where a member state has refused , suspended or terminated a clinical investigation , or has called for a substantial modification or temporary halt of a clinical investigation , or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds , that member state shall communicate its decision and the grounds therefor to all member states and the commission by means of the electronic system referred to in article 53 . ### where a member state has refused , suspended or terminated a clinical investigation , or has called for a substantial modification or temporary halt of a clinical investigation , or has been notified by the sponsor of the early termination of a clinical investigation on safety or efficacy grounds , that member state shall communicate its decision and the grounds for that decision to all member states and the commission by means of the electronic system referred to in article 53 .


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


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


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


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


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


### member states shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory , and that is brought to their knowledge in accordance with article 61 is , at national level , evaluated centrally by their competent authority , if possible together with the manufacturer . ### member states shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory , and that is brought to their knowledge in accordance with article 61 is , at national level , evaluated centrally by their competent authority , if possible together with the manufacturer . the competent authority shall take into account the views of all relevant stakeholders , including patient and healthcare professionals ' organisations .


### the national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions , taking into account criteria such as causality , detectability and probability of recurrence of the problem , frequency of use of the device , probability of occurrence of harm and severity of harm , clinical benefit of the device , intended and potential users , and population affected . they shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action . they shall monitor the manufacturer ' s investigation of the incident . ### the national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions , taking into account criteria such as causality , detectability and probability of recurrence of the problem , frequency of use of the device , probability of occurrence of harm and severity of harm , clinical benefit of the device , intended and potential users , and population affected . they shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action . they shall monitor the manufacturer ' s investigation of the incident , as well as they shall take into account patients ' opinions .


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


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


### chapter ii making available of devices , obligations of economic operators , reprocessing , ce marking , free movement ### chapter vi making available of devices , obligations of economic operators , reprocessing , ce marking , free movement articles under this chapter : 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 16 , 17 , 18 , 19 , 20 , 21 , 22


### chapter iii identification and traceability of devices , registration of devices and of economic operators , summary of safety and clinical performance , european databank on medical devices ### chapter viii identification and traceability of devices , registration of devices and of economic operators , european databank on medical devices articles under this chapter : 23 , 24 , 25 , 27


### chapter iv notified bodies ### chapter iv notified bodies articles under this chapter : 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 40a , 43


### chapter v classification and conformity assessment ### chapter ii classification of medical devices articles under this chapter : 41


### chapter vi clinical evaluation and clinical investigations ### chapter v clinical evaluation and clinical investigations articles under this chapter : 49 , 50 , 50a , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60


### chapter vii vigilance and market surveillance ### chapter ix vigilance and market surveillance articles under this chapter : 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75


### chapter viii cooperation between member states , medical device coordination group , eu reference laboratories , device registers ### chapter x cooperation between member states , medical device coordination group , eu reference laboratories , device registers articles under this chapter : 76 , 77 , 78 , 78a , 79 , 80 , 81 , 82 , 83


### chapter ix confidentiality , data protection , funding , penalties ### chapter xi confidentiality , data protection , funding , penalties articles under this chapter : 84 , 85 , 86 , 87


### in the case of biological substances other than those referred to in sections 10 . 1 . and 10 . 2 . , the processing , preservation , testing and handling of those substances shall be carried out so as to provide optimal safety for patients , users and , where applicable , other persons . in particular , safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process . ### in the case of biological substances other than those referred to in sections 10 . 1 . and 10 . 2 . , the processing , preservation , testing and handling of those substances shall be carried out so as to provide optimal safety for patients , users and , where applicable , other persons , including in the waste disposal chain . in particular , safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or inactivation in the course of the manufacturing process .


### if the device is reusable , information on the appropriate processes to allow reuse , including cleaning , disinfection , decontamination , packaging and , where appropriate , the validated method of re - sterilisation . information should be provided to identify when the device should no longer be reused , e . g . signs of material degradation or the maximum number of allowable reuses . ### if the device is reusable , information on the appropriate processes to allow reuse , including cleaning , disinfection , decontamination , packaging , the maximum number of allowable reuses and , where appropriate , the validated method of re - sterilisation . information should be provided to identify when the device should no longer be reused , e . g . signs of material degradation .


### if the device bears an indication that the device is for single use , information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re - used . if in accordance with point c ) of section 19 . 1 no instructions for use are needed , the information shall be made available to the user upon request . ### with the exception of devices referred to in article 15b , if the device bears an indication that the device is for single use , all information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re - used . if in accordance with point c ) of section 19 . 1 no instructions for use are needed , the information shall be made available to the user upon request .


### the pmcf plan and pmcf evaluation report in accordance with part b of annex xiii or any justification why a pmcf is not deemed necessary or appropriate . ### the pmcf plan and pmcf evaluation report , including a review of the pmcf evaluation report by an independent scientific body for class iii medical devices , in accordance with part b of annex xiii or any justification why a pmcf is not deemed necessary or appropriate .


### 1 . 4 . the organisational structure , distribution of responsibilities and operation of the notified body shall be such that it assures confidence in the performance and results of the conformity assessment activities conducted . the organisational structure and the functions , responsibilities and authority of its top - level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented . ### 1 . 4 . the organisational structure , distribution of responsibilities and operation of the notified body shall be such that it assures confidence in the performance and results of the conformity assessment activities conducted . the organisational structure and the functions , responsibilities and authority of its top - level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented . this information shall be made publicly available .


### 2 . 3 . the notified body , its top - level management and the personnel responsible for carrying out the conformity assessment tasks shall not : - be the designer , manufacturer , supplier , installer , purchaser , owner , user or maintainer of the products , nor the authorised representative of any of those parties . this shall not preclude the purchase and use of assessed products that are necessary for the operations of the notified body , the conduct of the conformity assessment or the use of such products for personal purposes ; - be directly involved in the design , manufacture or construction , the marketing , installation , use or maintenance of the products which they assess , or represent the parties engaged in those activities . they shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified ; - offer or provide any service which may jeopardise the confidence in their independence , impartiality or objectivity . in particular , they shall not offer or provide consultancy services to the manufacturer , his authorised representative , a supplier or a commercial competitor as regards the design , construction , marketing or maintenance of the products or processes under assessment . this does not preclude general training activities relating to medical device regulations or related standards that are not client specific . ### 2 . 3 . the notified body , its top - level management and the personnel responsible for carrying out the conformity assessment tasks shall not : - be the designer , manufacturer , supplier , installer , purchaser , owner , user or maintainer of the products , nor the authorised representative of any of those parties . this shall not preclude the purchase and use of assessed products that are necessary for the operations of the notified body , the conduct of the conformity assessment or the use of such products for personal purposes ; - be directly involved in the design , manufacture or construction , the marketing , installation , use or maintenance of the products which they assess , or represent the parties engaged in those activities . they shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified ; - offer or provide any service which may jeopardise the confidence in their independence , impartiality or objectivity . in particular , they shall not offer or provide consultancy services to the manufacturer , his authorised representative , a supplier or a commercial competitor as regards the design , construction , marketing or maintenance of the products or processes under assessment . this does not preclude general training activities relating to medical device regulations or related standards that are not client specific . the notified body shall provide evidence to the national authority that there are no conflicts of interest in compliance with this point . the national authority shall to the commission twice a year in full transparency .


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


### 3 . confidentiality the personnel of a notified body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this regulation , except in relation to the national authorities responsible for notified bodies , competent authorities or the commission . proprietary rights shall be protected . to this end , the notified body shall have documented procedures in place . ### 3 . confidentiality the personnel of a notified body shall observe professional secrecy with regard to information obtained in carrying out their tasks under this regulation , only in justified cases and except in relation to the national authorities responsible for notified bodies , competent authorities or the commission . proprietary rights shall be protected . to this end , the notified body shall have documented procedures in place . where information and data are requested by the public or healthcare professionals , the notified body shall make publicly available the reasons for such information being subject to non - disclosure .


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