### it is necessary to provide for transitional arrangements that allow the making available on the market and the putting into service of pressure equipment which complies with directive 97 / 23 / ec . ### it is necessary to provide for reasonable transitional arrangements that allow the making available on the market and putting into service , without the need to comply with further product requirements , of pressure equipment that has already been placed on the market in accordance with directive 97 / 23 / ec before the date of application of national measures transposing this directive . distributors should therefore be able to supply pressure equipment that has been placed on the market , namely stock that is already in the distribution chain , before the date of application of national measures transposing this directive .


### member states should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant to this directive and ensure that they are implemented . those penalties must be effective , proportionate and dissuasive . ### member states should lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this directive and ensure that these rules are enforced . the penalties provided for should be effective , proportionate and dissuasive .


### the obligation to transpose this directive into national law should be confined to those provisions which represent a substantive change as compared with directive 97 / 23 / ec . the obligation to transpose the provisions which are unchanged arises under directive 97 / 23 / ec . ### the obligation to transpose this directive into national law should be confined to those provisions which represent a substantive amendment as compared to the earlier directive . the obligation to transpose the provisions which are unchanged arises under the earlier directive .


### for the purposes of this directive the following definitions apply : ### for the purposes of this directive the following definitions shall apply :


### ‘ accreditation’ means accreditation as defined in article 2 of regulation no 765 / 2008 ; ### ‘ accreditation’ means accreditation as defined in point 10 of article 2 of regulation no 765 / 2008 ;


### ‘ national accreditation body’ means national accreditation body as defined in article 2 of regulation no 765 / 2008 ; ### ‘ national accreditation body’ means national accreditation body as defined in point 11 of article 2 of regulation no 765 / 2008 ;


### ‘ recall’ means any measure aimed at achieving the return of pressure equipment that has already been made available to the user ; ### ‘ recall’ means any measure aimed at achieving the return of pressure equipment that has already been made available to the consumers or other users ;


### this directive shall not affect member states ' entitlement to lay down such requirements as they may deem necessary to ensure that persons and , in particular , workers are protected during use of the pressure equipment in question provided that this does not mean modifications to such equipment in a way not specified in this directive . ### this directive shall not affect member states ' entitlement to lay down such requirements as they may deem necessary to ensure that persons and , in particular , workers are protected during use of the pressure equipment or assemblies in question provided that this does not mean modifications to such equipment or assemblies in a way not specified in this directive .


### member states may require , to the extent that it is needed for safe and correct use of pressure equipment , the information referred to in points 3 . 3 and 3 . 4 of annex i to be provided in the official language of the union which may be determined by the member state in which the equipment reaches the user . ### member states may require , to the extent that it is needed for safe and correct use of pressure equipment , the information referred to in points 3 . 3 and 3 . 4 of annex i to be provided in a language easily understood by consumers , other users and market surveillance authorities .


### for pressure equipment referred to in article 4 and , manufacturers shall draw up the technical documentation referred to in annex ii and carry out the conformity assessment procedure referred to in article 14 or have it carried out . ### for pressure equipment referred to in article 4 and , manufacturers shall draw up the technical documentation referred to in annex ii and have the relevant conformity assessment procedure referred to in article 14 carried out .


### manufacturers shall ensure that procedures are in place for series production to remain in conformity . changes in pressure equipment design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of pressure equipment is declared shall be adequately taken into account . ### manufacturers shall ensure that procedures are in place for series production to remain in conformity with this directive . changes in pressure equipment design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of pressure equipment is declared shall be adequately taken into account .


### manufacturers shall ensure that their pressure equipment bear a type , batch or serial number or other element allowing their identification , or , where the size or nature of the equipment does not allow it , that the required information is provided on the packaging or in a document accompanying the equipment . ### manufacturers shall ensure that the pressure equipment which they have placed on the market bear a type , batch or serial number or other element allowing their identification , or , where the size or nature of the equipment does not allow it , that the required information is provided on the packaging or in a document accompanying the equipment .


### manufacturers shall indicate their name , registered trade name or registered trade mark , the postal address , and , if available , the website address at which they can be contacted on the pressure equipment or , where that is not possible , on their packaging or in a document accompanying the equipment . the address must indicate a single point at which the manufacturer can be contacted . ### manufacturers shall indicate on the pressure equipment their name , registered trade name or registered trade mark and the postal address at which they can be contacted or , where that is not possible , on their packaging or in a document accompanying the equipment . the address shall indicate a single point at which the manufacturer can be contacted . the contact details shall be in a language easily understood by consumers , other users and market surveillance authorities .


### the obligations laid down in article 6 and the drawing up of technical documentation shall not form part of the authorised representative ' s mandate . ### the obligations laid down in article 6 and the obligation to draw up technical documentation referred to in article 6 shall not form part of the authorised representative ' s mandate .


### before making pressure equipment referred to in article 4 and available on the market distributors shall verify that the pressure equipment bears the ce marking , that it is accompanied by the required documents and by instructions and safety information in accordance with points 3 . 3 and 3 . 4 of annex i , in a language which can be easily understood by consumers and other users in the member state in which the pressure equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 . ### before making pressure equipment referred to in article 4 and available on the market distributors shall verify that the pressure equipment bears the ce marking , that it is accompanied by the required documents and by instructions and safety information in accordance with points 3 . 3 and 3 . 4 of annex i , in a language which can be easily understood by consumers and other users in the member state in which the pressure equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 respectively .


### before making pressure equipment referred to in article 4 available on the market distributors shall verify that the pressure equipment is accompanied by adequate instructions for use , in a language which can be easily understood by consumers and other users in the member state in which the pressure equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 . ### before making pressure equipment referred to in article 4 available on the market distributors shall verify that the pressure equipment is accompanied by adequate instructions for use , in a language which can be easily understood by consumers and other users in the member state in which the pressure equipment is to be made available on the market , and that the manufacturer and the importer have complied with the requirements set out in article 6 and and article 8 respectively .


### distributors who consider or have reason to believe that pressure equipment which they have made available on the market is not in conformity with this directive shall make sure that the corrective measures necessary to bring that equipment into conformity , to withdraw it or recall it , if appropriate , are taken . furthermore , where the pressure equipment presents a risk , distributors shall immediately inform the competent national authorities of the member states in which they made the equipment available to that effect , giving details , in particular , of the non - compliance and of any corrective measures taken . ### distributors who consider or have reason to believe that pressure equipment which they have made available on the market is not in conformity with this directive shall make sure that the corrective measures necessary to bring that equipment into conformity , to withdraw it or recall it , if appropriate , are taken . furthermore , where the pressure equipment presents a risk , distributors shall immediately inform the competent national authorities of the member states in which they made the equipment available on the market to that effect , giving details , in particular , of the non - compliance and of any corrective measures taken .


### where pressure equipment is subject to more than one union act requiring an eu declaration of conformity , a single eu declaration of conformity shall be drawn up in respect of all such union acts . that declaration shall contain the identification of the acts concerned including the publication references . ### where pressure equipment is subject to more than one union act requiring an eu declaration of conformity , a single eu declaration of conformity shall be drawn up in respect of all such union acts . that declaration shall contain the identification of the union acts concerned including their publication references .


### a conformity assessment body shall be established under national law and have legal personality . ### a conformity assessment body shall be established under national law of a member state and have legal personality .


### it shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities . ### a conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities .


### the personnel responsible for carrying out conformity assessment activities shall have the following : ### the personnel responsible for carrying out conformity assessment tasks shall have the following :


### the impartiality of the conformity assessment bodies , their top level management and of the assessment personnel shall be guaranteed . ### the impartiality of the conformity assessment bodies , their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed .


### the remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments . ### the remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments .


### conformity assessment bodies shall participate in , or ensure that their assessment personnel are informed of , the relevant standardisation activities and the activities of the notified body coordination group established under the relevant union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group . ### conformity assessment bodies shall participate in , or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of , the relevant standardisation activities and the activities of the notified body coordination group established under the relevant union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group .


### presumption of conformity ### presumption of conformity of notified bodies


### that application shall be accompanied by a description of the conformity assessment activities , the conformity assessment module or modules and the pressure equipment for which that body claims to be competent , as well as by an accreditation certificate , where one exists , issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in article 24 or 25 . ### the application for notification shall be accompanied by a description of the conformity assessment activities , the conformity assessment module or modules and the pressure equipment for which that body claims to be competent , as well as by an accreditation certificate , where one exists , issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in article 24 or 25 .


### the commission shall make publicly available the list of the notified bodies under this directive , including the identification numbers that have been allocated to them and the activities for which they have been notified . ### the commission shall make publicly available the list of the bodies notified under this directive , including the identification numbers that have been assigned to them and the activities for which they have been notified .


### the commission shall ensure that that list is kept up to date . ### the commission shall ensure that the list is kept up to date .


### the notifying member state shall provide the commission , on request , with all information relating to the basis for the notification or the maintenance of the competence of the body concerned . ### the notifying member state shall provide the commission , on request , with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned .


### where a conformity assessment body finds that essential safety requirements set out in annex i or corresponding harmonised standards have not been met by a manufacturer , it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate . ### where a notified body finds that essential safety requirements set out in annex i or corresponding harmonised standards or other technical specifications have not been met by a manufacturer , it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate .


### any circumstances affecting the scope of and conditions for notification ; ### any circumstances affecting the scope of or conditions for notification ;


### amendments of annexes ### delegated power


### the commission shall be empowered to adopt delegated acts in accordance with article 41 concerning the reclassification of pressure equipment when it has any of the following considerations : ### in order to take into account technical developments in pressure equipment technology , the commission shall be empowered to adopt delegated acts in accordance with article 41 reclassifying pressure equipment so as to :


### an item or family of pressure equipment referred to in article 4 should be subject to the requirements of article 4 ; ### make an item or family of pressure equipment referred to in article 4 subject to the requirements of article 4 ;


### an assembly or family of assemblies referred to in article 4 should be subject to the requirements of article 4 ; ### make an assembly or family of assemblies referred to in article 4 subject to the requirements of article 4 ; or


### an item or family of pressure equipment should be classified , by way of derogation from the requirements of annex ii , in another category . ### classify an item or family of pressure equipment , by way of derogation from the requirements of annex ii , in another category .


### member states shall adopt and publish by 1 march 2015 at the latest , the laws , regulations and administrative provisions necessary to comply with articles 2 to , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 17 , 18 , 19 to , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 42 , 43 and annexes iii and iv . they shall forthwith communicate to the commission the text of those measures . ### member states shall adopt and publish , by 1 march 2015 , the laws , regulations and administrative provisions necessary to comply with article 2 to , articles 6 to 12 , 17 and 18 , article 19 , and , articles 20 to 38 , 42 and 43 and annexes iii and iv . they shall forthwith communicate the text of those measures to the commission .


### eu declaration of conformity ### eu declaration of conformity 1 _________________ 1 it is optional for the manufacturer to assign a number to the declaration of conformity .


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


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


### it is appropriate to set out clearly the general obligations of the different economic operators , including importers and distributors as laid down in the new legislative framework for the marketing of products , without prejudice to the specific obligations laid down in the different parts of this regulation , to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators . ### it is appropriate to set out clearly the general obligations of the different economic operators , including importers and distributors as laid down in the new legislative framework for the marketing of products , without prejudice to the specific obligations laid down in the different parts of this regulation , to enhance understanding of the legal requirements and thus to improve regulatory compliance by the relevant operators . conditions enabling small and medium - sized enterprises with smart specialisation to have easier access to this market should be established .


### patients who are implanted with a device should be given essential information related to the implanted device allowing it to be identified and containing any necessary warnings or precautions to be taken , for example indications as to whether or not it is compatible with certain diagnostic devices or with scanners used for security controls . ### patients who are going to be implanted with a device should be given beforehand essential information related to the implanted device allowing it to be identified and containing information about the main characteristic of the device , the potential adverse effects , a warning of the potential health risks , post - operative follow - up care measures and 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 . member states may introduce national provisions requiring that the implant card also includes information on post - operative follow - up care measures and that it is signed by both the patient and the surgeon responsible for the surgery .


### medical devices should , as a general rule , bear the ce marking to indicate their conformity with this regulation so that they can move freely within the union and be put into service in accordance with their intended purpose . member states should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this regulation . ### medical devices should , as a general rule , bear the ce marking to indicate their conformity with this regulation so that they can move freely within the union and be put into service in accordance with their intended purpose . member states should not create obstacles to their placing on the market or putting into service for reasons related to the requirements laid down in this regulation . however member states should be allowed to decide whether to restrict the use of any specific type of medical device in relation to aspects that are not covered by this regulation .


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


### for high - risk medical devices , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available . ### for high - risk medical devices , in the interests of increased transparency , manufacturers should summarise the main safety and performance aspects of the device and the outcome of the clinical evaluation in a document that should be publicly available .


### the conformity assessment procedures should be simplified and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field . ### the conformity assessment procedures should be strengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field .


### the rules on clinical investigations should be in line with major international guidance in this field , such as the international standard iso 14155 : 2011 on good clinical practice for clinical investigations of medical devices for human subjects and the most recent version of the world medical association declaration of helsinki on ethical principles for medical research involving human subjects to ensure that clinical investigations conducted in the union are accepted elsewhere and that clinical investigations conducted outside the union in accordance with international guidelines can be accepted under this regulation . ### the rules on clinical investigations should be in line with major international guidance in this field , such as the international standard iso 14155 : 2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent version of the world medical association declaration of helsinki on ethical principles for medical research involving human subjects to ensure that clinical investigations conducted in the union are accepted elsewhere and that clinical investigations conducted outside the union in accordance with international guidelines can be accepted under this regulation .


### sponsors should report certain adverse events occurring during clinical investigations to the member states concerned , which should have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation . such information should be communicated to the other member states . ### sponsors should report adverse events occurring during clinical investigations to the member states concerned , which shall have the possibility to terminate or suspend the investigations if considered necessary to ensure a high level of protection of the subjects enrolled in a clinical investigation . such information shall be communicated to the other member states , the mdcg and the commission .


### 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 shall be empowered to report suspected serious incidents at national level using harmonised formats . the national competent authorities shall inform manufacturers and , if appropriate , their subsidiaries and sub - contractors , and share the information with their peers , other member states , the mdcg and the commission when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents .


### the assessment of reported serious incidents and field safety corrective actions should be conducted at national level but coordination should be ensured where similar incidents have occurred or field safety corrective actions have to be carried out in more than one member state with the objective of sharing resources and ensuring consistency regarding the corrective action . ### the assessment of reported serious incidents and field safety corrective actions should be conducted at national level but where similar incidents have occurred or field safety corrective actions have to be carried out in more than one member state coordination , with the objective of sharing resources and ensuring consistency regarding the corrective action , and transparency of procedures should be ensured .


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


### the commission should provide scientific , technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively implemented at union level based on sound scientific evidence . ### the commission should provide scientific , technical and corresponding logistic support to the coordinating national authority and ensure that the regulatory system for medical devices is effectively and uniformly implemented at union level based on sound scientific evidence .


### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and notably human dignity , the integrity of the person , the protection of personal data , the freedom of art and science , the freedom to conduct business and the right to property . this regulation should be applied by the member states in accordance with those rights and principles . ### this regulation respects the fundamental rights and observes the principles recognised in particular by the charter of fundamental rights of the european union and notably human dignity , the integrity of the person , the principle of free and informed consent , the protection of personal data , the freedom of art and science , the freedom to conduct business and the right to property , as well as the convention on human rights . this regulation should be applied by the member states in accordance with those rights and principles .


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


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


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


### products that contain or consist of biological substances or organisms other than those referred to in points and that are viable , including living micro - organisms , bacteria , fungi or virus ; ### all products that contain or consist of biological substances or organisms other than those referred to in points and that are viable including living micro - organisms , bacteria , fungi or virus ;


### ' medical device ' means any instrument , apparatus , appliance , software , implant , reagent , material or other article , intended by the manufacturer to be used , alone or in combination , for human beings for one or more of the specific medical purposes of : ### ' medical device ' means any instrument , apparatus , appliance , software , implant , reagent , material or other article , intended by the manufacturer to be used , alone or in combination , for human beings for one or more of the specific direct or indirect medical purposes of :


### – diagnosis , prevention , monitoring , treatment or alleviation of disease , ### – diagnosis , prevention , monitoring , prediction , treatment or alleviation of disease ,


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


### ‘ single - use device’ means a device that is intended to be used on an individual patient during a single procedure . ### ' single - use device ' means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse .


### ‘ reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning , disinfection , sterilisation and related procedures , as well as testing and restoration of the technical and functional safety of the used device ; ### ‘ reprocessing’ means the process carried out on a used device in order to allow its safe reuse including cleaning , disinfection , sterilisation and related procedures , as well as testing and restoration of the technical and functional safety of the used device ; routine device maintenance service activities are not included in this definition ;


### – foetal distress , foetal death or a congenital abnormality or birth defect ; ### – foetal distress , foetal death or a congenital physical or mental impairments or birth defect ;


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission may on its own initiative or shall at the request of a member state by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission may , at the request of a member state or on its own initiative and following consultation with the manufacturer in question on the basis of concerns about patient safety or in the light of new scientific findings , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission may on its own imitative , or shall at the request of a member state , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 .


### the commission may , at the request of a member state or on its own initiative , by means of implementing acts , determine whether or not a specific product , or category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . ### the commission may , at the request of a member state and after consultating the mdcg and the undertaking concerned , by means of implementing acts , determine whether or not a specific novel product , or new category or group of products , falls within the definitions of ' medical device ' or ' accessory to a medical device ' . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 88 . this paragraph shall not apply to products already authorised .


### devices that are manufactured and used within a single health institution shall be considered as being put into service . the provisions regarding ce marking referred to in article 18 and the obligations laid down in articles 23 to 27 shall not apply to those devices , provided that manufacture and use of those devices occur under the health institution ' s single quality management system . ### devices that are manufactured and used within a single health institution shall be considered as being put into service . the provisions regarding ce marking referred to in article 18 and the obligations laid down in articles 23 , 26 and 27 shall not apply to those devices , provided that manufacture and use of those devices occur under the health institution ' s single quality management system .


### a device offered by means of information society services as defined in article 1 of directive 98 / 34 / ec to a natural or legal person established in the union shall comply with this regulation at the latest when the device is placed on the market . ### a device offered by means of information society services as defined in article 1 of directive 98 / 34 / ec to a natural or legal person established in the union shall comply with this regulation at the latest by the day on which the device is placed on the market .


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


### without prejudice to national provisions regarding professional qualifications , manufacturers of custom - made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture . ### without prejudice to national provisions regarding professional qualifications , manufacturers of custom - made devices may demonstrate their expertise referred to in the first sentence by at least two years of professional experience within the relevant field of manufacture .


### for devices , other than custom - made and investigational devices , a system for unique device identification shall be put in place in the union . the udi system shall allow the identification and traceability of devices and shall consist of the following : ### for class&#160 ; ii devices , other than custom - made and investigational devices , a system for unique device identification shall be put in place in the union . the udi system shall allow the identification and traceability of devices and shall consist of the following :


### the legitimate interest in protecting commercially sensitive information ; ### the legitimate interest in protecting commercially sensitive information , providing that it does not conflict with public health protection ;


### to enable the public to be adequately informed about devices placed on the market , about the corresponding certificates issued by notified bodies and about the relevant economic operators ; ### to enable the public to be adequately informed about devices placed on the market , about the corresponding certificates issued by notified bodies and about the relevant economic operators , with the proviso that manufacturers must be able to maintain commercial confidentiality on this highly innovative market ;


### the national authority responsible for notified bodies shall safeguard the confidentiality of the information it obtains . however , it shall exchange information on a notified body with other member states and the commission . ### the national authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains . however , it shall exchange information on a notified body with other member states and the commission .


### within 14 days of the submission referred to in paragraph 2 , the commission shall designate a joint assessment team made up of at least two experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies . the list shall be drawn up by the commission in cooperation with the mdcg . at least one of these experts shall be a representative of the commission who shall lead the joint assessment team . ### within 14 days of the submission referred to in paragraph 2 , the commission shall designate a joint assessment team made up of at least three experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies . the list shall be drawn up by the commission in cooperation with the mdcg . at least one of these experts shall be a representative of the commission , and at least one other shall come from a member state other than that in which the applicant conformity assessment body is established ; the commission representative shall lead the joint assessment team .


### the national authority responsible for notified bodies shall submit its assessment report and its draft notification to the commission which shall immediately transmit those documents to the mdcg and to the members of the joint assessment team . upon request by the commission , those documents shall be submitted by the authority in up to three official union languages . ### the national authority responsible for notified bodies shall submit its assessment report and its draft notification to the commission which shall immediately transmit those documents to the mdcg and to the members of the joint assessment team . if the assessment team draws up a separate opinion , this too shall be submitted to the commission for forwarding to the mdcg . upon request by the commission , those documents shall be submitted by the authority in up to three official union languages .


### 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 final opinion regarding the assessment report , the draft notification and , where appropriate , the separate opinion drawn up by the assessment team , 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 . if , in taking its decision , the relevant national authority goes against the mdcg ' s recommendation , it must outline its reasons for so doing to the commission in writing .


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


### 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 . this assessment shall include an on - site visit to each notified body . the assessment shall also include a review of samples of the design dossier assessments carried out by the notified body to determine the ongoing competence of the notified body and quality of its assessments , in particular the notified body ' s ability to evaluate and assess clinical evidence .


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


### in the event of restriction , suspension or withdrawal of a notification , the member state shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request . ### in the event of restriction , suspension or withdrawal of a notification , the member state shall immediately inform the commission which shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request .


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


### 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 shall be empowered to adopt implementing acts in accordance with article 88 as regards the following :


### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application may not be lodged in parallel with more than one notified body for the same conformity assessment activity . ### where the conformity assessment procedure requires the involvement of a notified body , the manufacturer may apply to a notified body of his choice , provided that the body is notified for the conformity assessment activities , the conformity assessment procedures and the devices concerned . an application may not be lodged in parallel with more than one notified body for the same conformity assessment activity . the manufacturer shall forward the name of the notified body he has chosen to the competent national authority of the member state in which he has his head office .


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


### the notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body ' s decision regarding the conformity assessment . ### the notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body ' s decision regarding the conformity assessment . it shall also inform all of the competent national bodies without delay .


### the certificates issued by the notified bodies in accordance with annexes viii , ix and x shall be in an official union language determined by the member state in which the notified body is established or otherwise in an official union language acceptable to the notified body . the minimum content of the certificates is set out in annex xii . ### before issuing a certificate , the notified conformity assessment body shall take into account any findings set out in the clinical investigation report referred to in paragraph 59 of this regulation . the certificates issued by the notified bodies in accordance with annexes viii , ix and x shall be in an official union language determined by the member state in which the notified body is established or otherwise in an official union language acceptable to the notified body . the minimum content of the certificates is set out in annex xii .


### where a notified body finds that requirements of this regulation are no longer met by the manufacturer , it shall , taking account of the principle of proportionality , suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body . the notified body shall give the reasons for its decision . ### where a notified body finds that requirements of this regulation are no longer met by the manufacturer , it shall , taking account of the principle of proportionality , suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body . the notified body shall give the reasons for its decision and shall notify them to the competent authorities of the member states in which the medical device is manufactured and placed on the market , the commission and the mdcg .


### by way of derogation from article 42 , any competent authority may authorise , on duly justified request , the placing on the market or putting into service within the territory of the member state concerned , of a specific device for which the procedures referred to in article 42 have not been carried out and use of which is in the interest of public health or patient safety . ### by way of derogation from article 42 , any competent authority may authorise , on duly justified request , the placing on the market or putting into service within the territory of the member state concerned , of a specific device for which the procedures referred to in article 42 have not been carried out and use of which is in the interest of public health or patient safety , provided that the medical device coordination group has authorised it . this derogation shall be possible only if the manufacturer submits the requisite clinical data to the competent authority within the prescribed period .


### the member state shall inform the commission and the other member states of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient . ### the member state shall inform the commission , the notified body responsible for assessing the relevant medical device , the mdcg and the other member states of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient .


### where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate , adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body , the clinical performances intended and the claims of the manufacturer . the adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non - clinical testing methods alone , including performance evaluation , bench testing and pre - clinical evaluation , has to be duly substantiated in the technical documentation referred to in annex ii . ### except for class iii devices , where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate , adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body , the clinical performances intended and the claims of the manufacturer . the adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non - clinical testing methods alone , including performance evaluation , bench testing and pre - clinical evaluation , has to be duly substantiated in the technical documentation referred to in annex ii . exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority .


### to verify that , under normal conditions of use , devices are designed , manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number of article 2 , and achieve the performances intended as specified by the manufacturer ; ### to verify that , under normal conditions of use , devices are designed , manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number of article 2 , and achieve the performances intended as specified by the manufacturer or sponsor ;


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


### member states shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor , the institution of the investigation site and the investigators involved , as well as free of any other undue influence . ### member states shall ensure that the persons assessing the application are independent of the sponsor and the investigators involved , as well as free of any other undue influence .


### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . ### member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of patients shall be taken into account . the list of the reviewers should be made available to the sponsor


### member states shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor , the institution of the investigation site and the investigators involved , as well as free of any other undue influence . ### member states shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor , the institution of the investigation site and the investigators involved , as well as free of any other undue influence . member states shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience . in the assessment , the view of at least one person whose primary area of interest is non - scientific shall be taken into account . the view of at least one patient shall be taken into account . realization of the clinical investigation shall be subject to an examination by the concerned ethics committee .


### protection of commercially sensitive information ; ### protection of commercially sensitive information ; data on adverse events and safety data shall not be considered commercially sensitive information ;


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


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


### 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 grounds , that member state shall communicate such facts and its decision and the grounds therefor to all member states and the commission by means of the electronic system referred to in article 53 .


### 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 . ### if the investigation is conducted in more than one member state the sponsor shall notify all member states concerned of the early termination in one member state and of the overall end of the clinical investigation . that notification shall be made within 15 days from the end of the clinical investigation in one or more member states .


### within one year from the end of the clinical investigation , the sponsor shall submit to the member states concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in section 2 . 7 of chapter i of annex xiv . where , for scientific reasons , it is not possible to submit the clinical investigation report within one year , it shall be submitted as soon as it is available . in this case , the clinical investigation plan referred to in section 3 of chapter ii of annex xiv shall specify when the results of the clinical investigation are going to be submitted , together with an explanation . ### within one year from the end of the clinical investigation , the sponsor shall submit to the member states concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in section 2 . 7 of chapter i of annex xiv , together with all the data collected during the clinical investigation , including negative findings . where , for scientific reasons , it is not possible to submit the clinical investigation report within one year , it shall be submitted as soon as it is available . in this case , the clinical investigation plan referred to in section 3 of chapter ii of annex xiv shall specify when the results of the clinical investigation are going to be submitted , together with an explanation .


### by means of the electronic system referred to in article 53 , the sponsor of a clinical investigation to be conducted in more than one member state may submit , for the purpose of article 51 , a single application that , upon receipt , is transmitted electronically to the member states concerned . ### by means of the electronic system referred to in article 53 , the sponsor of a clinical investigation may submit , for the purpose of article 51 , the application that , upon receipt , is transmitted electronically to the member states concerned .


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


### establish the results of the coordinated assessment in a report to be taken into account by the other member states concerned when deciding on the sponsor ' s application in accordance with article 51 . ### establish the results of the coordinated assessment in a report to be approved by the other member states concerned when deciding on the sponsor ' s application in accordance with article 51 .


### in the case of a clinical investigation for which the sponsor has used the single application referred to in article 58 , the sponsor shall report any event as referred to in paragraph 2 by means of the electronic system referred to in article 53 . upon receipt , this report shall be transmitted electronically to all member states concerned . ### in the case of a clinical investigation for which the sponsor has used the single application referred to in article 58 , the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in article 53 . upon receipt , this report shall be transmitted electronically to all member states concerned .


### manufacturers of custom - made devices shall report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the member state in which the device in question has been made available . ### manufacturers of custom - made devices shall immediately report any incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the member state in which the device in question has been made available .


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


### 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 an 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 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 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 .


### in the case of devices referred to in the first subparagraph of article 1 and where the serious incident or field safety corrective action may be related to a substance which , if used separately , would be considered to be a medicinal product , the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products , or the european medicines agency , that was consulted by the notified body in accordance with the second subparagraph of article 42 . ### in the case of devices referred to in the first subparagraph of article 1 and where the incident or field safety corrective action may be related to a substance which , if used separately , would be considered to be a medicinal product , the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products , or the european medicines agency , that was consulted by the notified body in accordance with the second subparagraph of article 42 .


### in the case of devices covered by this regulation in accordance with point of article 1 and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device , the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of article 42 . ### in the case of devices covered by this regulation in accordance with point of article 1 and where the incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device , the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of article 42 .


### after carrying out the assessment , the evaluating competent authority shall , through the electronic system referred to in article 62 , inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence of a serious incident , including information on the underlying events and the outcome of its assessment . ### after carrying out the assessment , the evaluating competent authority shall , through the electronic system referred to in article 62 , inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence , including information on the underlying events and the outcome of its assessment .


### where similar serious incidents related to the same device or type of device of the same manufacturer occur in more than one member state ; ### where similar incidents related to the same device or type of device of the same manufacturer occur in more than one member state ;


### to monitor the investigation of the serious incident by the manufacturer and the corrective action to be taken ; ### to monitor the investigation of the incident by the manufacturer and the corrective action to be taken ;


### to consult with the notified body that issued a certificate in accordance with article 45 for the device in question regarding the impact of the serious incident on the certificate ; ### to consult with the notified body that issued a certificate in accordance with article 45 for the device in question regarding the impact of the incident on the certificate ;


### manufacturers of devices classified in class iib and iii shall report to the electronic system referred to in article 62 any statistically significant increase in the frequency or severity of incidents that are not serious incidents or of expected undesirable side - effects that have a significant impact on the risk - benefit analysis referred to in sections 1 and 5 of annex i and which have led or may lead to unacceptable risks to the health or safety of patients , users or other persons when weighted against the intended benefits . the significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side - effects in respect of the device , or category or group of devices , in question during a specific time period as established in the manufacturer ' s conformity assessment . article 63 shall apply . ### manufacturers of devices classified in class iib and iii shall report to the electronic system referred to in article 62 any statistically significant increase in the frequency or severity of all incidents or of expected undesirable side - effects that have a significant impact on the risk - benefit analysis referred to in sections 1 and 5 of annex i and which have led or may lead to unacceptable risks to the health or safety of patients , users or other persons when weighted against the intended benefits . the significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side - effects in respect of the device , or category or group of devices , in question during a specific time period as established in the manufacturer ' s conformity assessment . article 63 shall apply .


### typology of serious incidents and field safety corrective actions in relation to specific devices , or categories or groups of devices ; ### typology of incidents and field safety corrective actions in relation to specific devices , or categories or groups of devices ;


### harmonised forms for the reporting of serious incidents and field safety corrective actions , periodic summary reports and trend reports by manufacturers as referred to in articles 61 and 64 ; ### harmonised forms for the reporting of incidents and field safety corrective actions , periodic summary reports and trend reports by manufacturers as referred to in articles 61 and 64 ;


### timelines for the reporting of serious incidents and field safety corrective actions , periodic summary reports and trend reports by manufacturers , taking into account the severity of the event to be reported as referred to in articles 61 and 64 ; ### timelines for the reporting of incidents and field safety corrective actions , periodic summary reports and trend reports by manufacturers , taking into account the severity of the event to be reported as referred to in articles 61 and 64 ;


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


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically plan , review and assess the functioning of their surveillance activities . to this end , member states shall draw up strategic monitoring plans which lay down a risk classification , surveillance intervals , the nature of the surveillance measures and the human and material resources to be used to carry out the monitoring . a review and assessment of the activities shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the commission may make recommendations for adjustments to the monitoring plans . the member state concerned shall make a summary of the results and of the commission’s recommendations accessible to the public .


### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public . ### the member states shall periodically review and assess the functioning of their surveillance activities . such reviews and assessments shall be carried out at least every two year and the results thereof shall be communicated to the other member states and the commission . the member state concerned shall make a summary of the results accessible to the public .


### where the competent authorities of a member state , based on vigilance data or other information , have sufficient reason to believe that a device presents a risk to the health or safety of patients , users or other persons , they shall carry out an evaluation in relation to the device concerned covering all the requirements laid down in this regulation that are relevant to the risk presented by the device . the relevant economic operators shall cooperate as necessary with the competent authorities . ### where the competent authorities of a member state , based on vigilance data or other information , have sufficient reason to believe that a device presents a risk to the health or safety of patients , users or other persons , they shall carry out an evaluation in relation to the device concerned covering all the requirements laid down in this regulation that are relevant to the risk presented by the device . the relevant economic operators shall cooperate as necessary with the competent authorities . in connection with that evaluation , the competent authorities shall inform the notified assessment bodies , in the case of class iia , iib and iii devices , and the other competent authorities of the findings of the evaluation and the measures that are to be taken on the basis of those findings .


### where , having performed an evaluation pursuant to article 69 , the competent authorities find that the device , which presents a risk to the health or safety of patients , users or other persons , does not comply with the requirements laid down in this regulation , they shall without delay require the relevant economic operator to take all appropriate and duly justified corrective action to bring the device into compliance with those requirements , to prohibit or restrict the making available of the device on the market , to subject the making available of the device to specific requirements , to withdraw the device from the market , or to recall it within a reasonable period , proportionate to the nature of the risk . ### where , having performed an evaluation pursuant to article 69 , the competent authorities find that the device , which presents a risk to the health or safety of patients , users or other persons , does not comply with the requirements laid down in this regulation , they shall immediately require the relevant economic operator to take all appropriate and duly justified corrective action to bring the device into compliance with those requirements , to prohibit or restrict the making available of the device on the market , to subject the making available of the device to specific requirements , to withdraw the device from the market , or to recall it within a reasonable period that is clearly defined and communicated to the relevant economic operator , proportionate to the nature of the risk .


### where the competent authorities consider that non - compliance is not restricted to their national territory , they shall inform the commission and the other member states of the results of the evaluation and of the actions which they have required the economic operators to take , by means of the electronic system referred to in article 68 . ### where the competent authorities consider that non - compliance is not restricted to their national territory , they shall immediately inform the commission and the other member states of the results of the evaluation and of the actions which they have required the economic operators to take , by means of the electronic system referred to in article 68 .


### the economic operators shall ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market throughout the union . ### the economic operators shall without delay ensure that all appropriate corrective action is taken in respect of all the devices concerned that they have made available on the market throughout the union .


### they shall notify the commission and the other member states , without delay , of those measures , by means of the electronic system referred to in article 68 . ### they shall notify the commission and the other member states , immediately , of those measures , by means of the electronic system referred to in article 68 .


### member states other than the member state initiating the procedure shall without delay inform the commission and the other member states of any additional information at their disposal relating to the non - compliance of the device concerned and of any measures adopted by them in relation to the device concerned . in the event of disagreement with the notified national measure , they shall without delay inform the commission and the other member states of their objections , by means of the electronic system referred to in article 68 . ### member states other than the member state initiating the procedure shall without delay inform the commission and the other member states of any additional information at their disposal relating to the non - compliance of the device concerned and of any measures adopted by them in relation to the device concerned . in the event of disagreement with the notified national measure , they shall immediately inform the commission and the other member states of their objections , by means of the electronic system referred to in article 68 .


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


### all member states shall ensure that appropriate restrictive measures are taken without delay in respect of the device concerned . ### all member states shall ensure that appropriate restrictive measures are taken immediately in respect of the device concerned .