In Vitro Diagnostic Medical Devices Regulation

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Article 10 General obligations of manufacturers 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. 2. Manufacturers shall establish, document, implement … 1,242 unchanged words … the context of legal proceedings. 14. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 27(1). 26(3). 15. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

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Article 28 Registration of manufacturers, authorised representatives and importers 1. Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 27 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body. 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (SRN) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer. 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 26. 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 27. 5. Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation. 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI. 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27 shall be accessible to the public. 8. The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 104.

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Article 48 Conformity assessment procedures 1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI. 2. Prior to … 561 unchanged words … of the scientific opinion by the EU reference laboratory as specified therein. 7. Manufacturers of class C devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, including and, in addition, to an assessment of the technical documentation as specified in Sections 4.4 to 4.8 Section 4 of that Annex of for at least one representative device per generic device group. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for technical documentation assessment set out in Section 5.1 of Annex IX. In addition to the procedures referred to in the first and second subparagraphs, for companion diagnostics the notified body shall for every device follow the procedure for technical documentation assessment laid down in Section 5.2 of Annex IX, and shall apply the procedure for technical documentation assessment laid down in Sections 4.1 to 4.8 of Annex IX and shall consult the competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in Section 5.2 of Annex IX. 8. Manufacturers of class C devices, other than devices for performance study, may, instead of the conformity assessment procedure pursuant to paragraph 7, choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI except its Section 5. For companion diagnostics the notified body shall in particular for every device consult a competent authority designated by the Member States in accordance with Directive 2001/83/EC or the EMA, as applicable, in accordance with the procedure set out in point (k) of Section 3 of Annex X. 9. Manufacturers of class B devices, other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including and, in addition, to an assessment of the technical documentation as specified in Sections 4.4 to 4.8 Section 4 of that Annex for at least one representative device per category of devices. In addition to the procedures referred to in the first subparagraph, for devices for self-testing and near-patient testing, the manufacturer shall follow the procedure for assessment of the … 368 unchanged words … Sections 3.4 and 4.3 of Annex IX and points (f) and (g) of Section 3. of Annex X. The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).

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Article 70 Performance studies regarding devices bearing the CE marking 1. Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1) (PMPF study), and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 69. The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex XIV. Points (b) to (l) and (p) of Article 58(5), and Articles 71, 72 and 73 73, and Article 76(5) and (6), and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies. 2. Where a performance study is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1), Articles 58 to 77 shall apply.

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Article 74 Coordinated assessment procedure for performance studies 1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article … 1,194 unchanged words … XIII, which shall be assessed separately by each Member State concerned. 13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter. 14. The procedure set out in this Article shall, until 27 25 May 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it. After 27 From 26 May 2029, all Member States shall be required to apply that procedure.

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Article 83 Trend reporting 1. Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 8 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information. The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79. 2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.

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Article 110 Transitional provisions 1. From 26 May 2022, any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void. 2. Certificates issued by notified bodies in accordance with Directive 98/79/EC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex VI to Directive 98/79/EC which shall become void at the latest on 27 May 2024. Certificates issued by notified bodies in accordance with Directive 98/79/EC from 25 May 2017 shall become void by 27 May 2024. 3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply and replace the corresponding requirements in that Directive. Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that issued the certificate referred to in the first subparagraph shall continue to be responsible for the appropriate surveillance in respect of all applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market from 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025. 5. By way of derogation from Directive 98/79/EC, devices which comply with this Regulation may be placed on the market before 26 May 2022. 6. By way of derogation from Directive 98/79/EC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2022. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2022. 7. As regards devices subject to the procedures laid down in Article 48(3) and (4), paragraph 5 of this Article applies provided that the necessary appointments to the MDCG and expert panels and of EU reference laboratories have been made. 8. By way of derogation from Article 10 and 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article Articles 26(3), 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC as specified in Decision 2010/227/EU. 9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(12) of Directive 98/79/EC shall keep the validity indicated in the authorisation. 10. Until the Commission has designated, pursuant to Article 24(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.

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Article 112 Repeal Without prejudice to Articles 110 (3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and the obligations of manufacturers as regards the making available of documentation, under Directive 98/79/EC, that Directive is repealed with effect from 26 May 2022 with the exception of: (a) Article 11, point (c) of Article 12(1) and Article 12(2) and (3) of Directive 98/79/EC, and the obligations relating to vigilance and performance studies provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation; and (b) Article 10 and 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC, and the obligations relating to registration of devices and economic operators, and certificate notifications provided for in the corresponding Annexes, which are repealed with effect from 18 months after the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs. Decision 2010/227/EU adopted in implementation of Directives 90/385/EEC, 93/42/EEC and 98/79/EC shall be repealed with effect from the later of the dates referred to in Article 113(2) and point (f) of Article 113(3) of this Regulation. References to the repealed Directive shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XV.

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Article 113 Entry into force and date of application 1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. 2. It shall apply from 26 May 2022. 3. By way of derogation from paragraph 2: (a) Article 27(3) Articles 26(3) and Article 51(5) shall apply from 27 November 2023; 18 months after the later of the dates referred to in point (f); (b) Articles 31 to 46 and Article 96 shall apply from 26 November 2017. However, from that date until 26 May 2022 the obligations on notified bodies pursuant to Articles 31 to 46 shall apply only to those bodies which submit an application for designation in accordance with Article 34; (c) Article 97 shall apply from 26 May 2018; (d) Article 100 shall apply from 25 November 2020; (e) for class D devices, Article 24(4) shall apply from 26 May 2023. For class B and class C devices Article 24(4) shall apply from 26 May 2025. For class A devices Article 24(4) shall apply from 26 May 2027; (f) without prejudice to the obligations on the Commission pursuant to Article 34 of Regulation (EU) 2017/745, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1) of that Regulation, Eudamed is not fully functional on 26 May 2022, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) of that Regulation. The provisions referred to in the preceding sentence are: Article 26, Article 28, Article 29, the second sentence of Article 36(2), Article 38(10), Article 39(2), the second subparagraph of Article 40(12), points (d) and (e) of Article 42(7), Article 49(2), Article 50(1), Articles 66 to 73, paragraphs 1 to 13 of Article 74, Articles 75 to 77, Article 81(2), Articles 82 and 83, Article 84(5) and (7) and the third subparagraph of Article 84(8), Article 85, Article 88(4), (7) and (8), Article 90(2) and (4), the last sentence of Article 92(2), Article 94(4), the second sentence of the first subparagraph of Article 110(3). Until Eudamed is fully functional the corresponding provisions of Directive 98/79/EC shall continue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first paragraph of this point regarding exchange of information including, and in particular, information regarding performance studies, vigilance reporting, registration of devices and economic operators, and certificate notifications. (g) The the procedure set out in Article 74 shall, shall apply from 26 May 2027 2029 without prejudice to Article 74(14). 74(14); (h) Article 110(10) shall apply from 26 May 2019.

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ANNEX III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex. 1. The post-market surveillance plan drawn up in accordance with Article 79. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 78. (a) The post-market surveillance plan shall address the collection and utilisation of available information, in particular: information concerning serious incidents, including information from PSURs, and field safety corrective actions, records referring to non-serious incidents and data on any undesirable side-effects, information from trend reporting, relevant specialist or technical literature, databases and/or registers, information, including feedbacks and complaints, provided by users, distributors and importers, and publicly-available information about similar medical devices. (b) The post-market surveillance plan shall cover at least: a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market; effective and appropriate methods and processes to assess the collected data; suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I; effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; methods and protocols to manage the events incidents subject to the trend report as provided for in Article 83, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users; reference to procedures to fulfil the manufacturers obligations laid down in Articles 78, 79 and 81; systematic procedures to identify and initiate appropriate measures including corrective actions; effective tools to trace and identify devices for which corrective actions might be necessary; and a PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable. 2. The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.

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ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES 1. ORGANISATIONAL AND GENERAL REQUIREMENTS 1.1. Legal status and organisational structure 1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third country with … 5,029 unchanged words … for class B and class C devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application. That plan shall ensure that all the entire range of devices covered by the certificate are is sampled over the period of validity of the certificate, and select and assign appropriately qualified and authorised personnel for conducting the individual audits. The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented. (b) Based on the audit programme it has drawn up, the notified … 2,886 unchanged words … in question shall use the same methods and principles as for the initial certification decision. If necessary, separate forms shall be established for re-certification taking into account the steps to be taken for certification, such as application and application review.

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ANNEX VIII CLASSIFICATION RULES 1. IMPLEMENTING RULES 1.1. Application of the classification rules shall be governed by the intended purpose of the devices. 1.2. If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. 1.3. Accessories for an in vitro diagnostic medical device shall be classified in their own right separately from the device with which they are used. 1.4. Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If the software is independent of any other device, it shall be classified in its own right. 1.5. Calibrators intended to be used with a device shall be classified in the same class as the device. 1.6. Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes shall be classified in the same class as the device. 1.7. The manufacturer shall take into consideration all classification and implementation rules in order to establish the proper classification for the device. 1.8. Where a manufacturer states multiple intended purposes for a device, and as a result the device falls into more than one class, it shall be classified in the higher class. 1.9. If several classification rules apply to the same device, the rule resulting in the higher classification shall apply. 1.10. Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays. 2. CLASSIFICATION RULES 2.1. Rule 1 Devices intended to be used for the following purposes are classified as class D: detection of the presence of, or exposure to, a transmissible agent in blood, blood components, cells, tissues or organs, or in any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration; detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation; determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management. 2.2. Rule 2 Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration, are classified as class C, except when intended to determine any of the following markers: ABO … 427 unchanged words … be used for in vitro diagnostic procedures; (c) specimen receptacles. 2.6. Rule 6 Devices not covered by the above-mentioned classification rules are classified as class B. 2.7. Rule 7 Devices which are controls without a quantitative or qualitative assigned value are classified as class B.

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ANNEX IX CONFORMITY ASSESSMENT BASED ON A QUALITY MANAGEMENT SYSTEM AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION CHAPTER I QUALITY MANAGEMENT SYSTEM 1. The manufacturer shall establish, document and implement a quality management system, as described in Article 10(8), and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2, and shall be subject to audit as laid down in Sections 2.3 and 2.4 and to surveillance as specified in Section 3. 2. Quality management system assessment 2.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include: the name of the manufacturer and address of its registered place of business and any additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative the name of the authorised representative and the address of the authorised representative's registered place of business, all relevant information on the device or group of devices covered by the quality management system, a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system, a draft of an EU declaration of conformity in accordance with Article 17 and Annex IV for the device model covered by the conformity assessment procedure, the documentation on the manufacturer's quality management system, a documented description of the procedures in place to fulfil the obligations arising from by the quality management system and required under this Regulation and of the undertaking by the manufacturer in question to apply those procedures, a description of the procedures in place to ensure that the quality management system remains adequate and effective, and … 691 unchanged words … body shall assess conformity with those standards or CS. The notified body shall assume that a quality management system which satisfies the relevant harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiate substantiates not doing so. The audit team of the notified body shall include at least one member with past experience of assessments of the technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such experience is not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of that team. The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to verify the manufacturing and other relevant processes. Moreover, in the case of class B and C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis as specified in accordance with provisions in Sections 4.4 to 4.8. Section 4. In choosing representative samples the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 99 and in particular, the novelty of the technology, the potential impact on the patient and standard medical practice, similarities in design, technology, manufacturing and, where applicable, sterilisation methods, the intended purpose and the results of any previous relevant assessments that have been carried out in accordance with this Regulation. The notified body in question shall document its rationale for the samples taken. If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality management system certificate. The notified body shall notify the manufacturer of tits its decision to issue the certificate. The decision shall contain the conclusions of the audit and a reasoned report. 2.4. The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether, after those changes, the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate. 3. Surveillance assessment applicable to class C and class D devices 3.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system. 3.2. The manufacturer shall give authorisation to the notified body to carry out all the necessary audits, including on-site … 406 unchanged words … in question shall specify the relevant sampling criteria and testing procedure. The notified body shall provide the manufacturer in question with an on-site audit report which shall include, if applicable, the result of the sample test. 3.5. In the case of class B and C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to specified in Sections 4.4 to 4.8 of Section 4 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the third paragraph of Section 2.3. 3.6. Notified bodies shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals. As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer. 3.7. If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it. CHAPTER II ASSESSMENT OF THE TECHNICAL DOCUMENTATION 4. Assessment of the technical documentation of class B, C and D devices and batch verification applicable to class D devices 4.1. In addition to the obligation laid down in Section 2, the manufacturer of devices shall lodge with the notified body an application for the assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2. 4.2. The application shall describe the design, manufacture and performance of the device in question. It shall include the technical documentation as referred to in Annexes II and III. In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in point (b) of Section 5.1. 4.3. The notified body shall examine assess the application by technical documentation using staff, employed by it, staff with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence. The notified body may require the application to be completed by having further tests carried out or requesting further … 2,174 unchanged words … kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.