Medical Devices Regulation

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Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) 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 … 1,258 unchanged words … market for the first time for its intended purpose; (30) manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark; trade mark; (31) fully refurbishing, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it … 1,364 unchanged words … of Article 2 of Regulation (EU) No 1025/2012; (71) common specifications (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

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Article 7 Claims In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: (a) ascribing functions and properties to the device which the device does not have; (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

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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 … 1,251 unchanged words … the context of legal proceedings. 15. 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 30(1). 29(4). 16. 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 74 Clinical investigations regarding devices bearing the CE marking 1. Where a clinical investigation 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 20(1), (PMCF investigation), and where the investigation 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 73. The sponsor shall include the documentation referred to in Chapter II of Annex XV as part of the notification. Points (b) to (k) and (m) of Article 62(4), Article Articles 75, Article 76, Article 76 and 77, and Article 80(5) and (6), and the relevant provisions of Annex XV shall apply to PMCF investigations. 2. Where a clinical investigation 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 20(1), Articles 62 to 81 shall apply.

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Article 78 Coordinated assessment procedure for clinical investigations 1. By means of the electronic system referred to in Article 73, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article … 751 unchanged words … clinical investigation would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned; (b) infringement of national law; or (c) considerations as regards subject safety and data reliability and robustness submitted under point (b) (d) of paragraph 4. Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in … 343 unchanged words … XV, 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 2027, be applied only by those of the Member States in which the clinical investigation is to be conducted which have agreed to apply it. After 27 From 26 May 2027, all Member States shall be required to apply that procedure.

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Article 84 Post-market surveillance plan The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 1 of Annex III. For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.

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Article 88 Trend reporting 1. Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects 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 risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as 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 incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84. 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 120 Transitional provisions 1. From 26 May 2020, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void. 2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC 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 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024. 3. By way of derogation from Article 5 of this Regulation, a device with which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which that is valid by virtue of paragraph 2 of this Article Article, may only be placed on the market or put into service until 26 May 2024, provided that from the date of application of this Regulation 26 May 2020 it continues to comply with either of those Directives, 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 in place of the corresponding requirements in those Directives. 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 of the applicable requirements relating to the devices it has certified. 4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred pursuant to in paragraph 2 3 of this Article, may continue to be made available on the market or put into service until 27 26 May 2025. 5. By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market prior to 26 May 2020. 6. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2020. 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 2020. 7. As regards devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall apply provided that the necessary appointments to the MDCG and expert panels have been made. 8. By way of derogation from Article 10a and 10a, point (a) of Article 10b(1) and Article 11(5) of Directive 90/385/EEC and Article 14(1) and (2) and (2), points (a) and (b) of Article 14a(1) and Article 16(5) of Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (d) of Article 123(3) and ending 18 months later, comply with Article 29(4) Articles 29(4), 31(1) and Article 56(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and 93/42/EEC, with, respectively, point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of Directive 93/42/EEC and with, respectively, Article 11(5) of Directive 90/385/EEC or Article 16(5) of Directive 93/42/EEC, as specified in Decision 2010/227/EU. 9. Authorisations granted by the competent authorities of the Member States in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall keep the validity indicated in the authorisation. 10. Devices falling within the scope of this Regulation in accordance with points (f) and point (g) of Article 1(6) which have been legally placed on the market or put into service in accordance with the rules in force in the Member States prior to 26 May 2020 may continue to be placed on the market and put into service in the Member States concerned. 11. Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2020 may continue to be conducted. As of 26 May 2020, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation. 12. Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.

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Article 122 Repeal Without prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the obligations of the Member States and manufacturers as regards vigilance and to the obligations of manufacturers as regards the making available of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from 26 May 2020, with the exception of: Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; Article 10a and 10a, point (a) of Article 10b(1) and Article 11(5) of Directive 90/385/EEC, and the obligations relating to registration of devices and economic operators, and to 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 point (d) of Article 123(3) of this Regulation; Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical investigations provided for in the corresponding Annexes, which are repealed with effect from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; and Article 14(1) and (2) and (2), points (a) and (b) of Article 14a(1) and Article 16(5) of Directive 93/42/EEC, and the obligations relating to registration of devices and economic operators, and to 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 point (d) of Article 123(3) of this Regulation. As regards the devices referred to in Article 120 (3) and (4) of this Regulation, the Directives referred to in the first paragraph shall continue to apply until 27 May 2025 to the extent necessary for the application of those paragraphs. Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall remain in force and continue to apply unless and until repealed by implementing acts adopted by the Commission pursuant to this Regulation. References to the repealed Directives shall be understood as references to this Regulation and shall be read in accordance with the correlation table laid down in Annex XVII to this Regulation.

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ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS CHAPTER I GENERAL REQUIREMENTS 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. … 5,955 unchanged words … Section 10.4.5.; (g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate; (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII; VI; (i) an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant; (j) where there is no indication of the date until when it … 1,604 unchanged words … 18; (ab) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.

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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 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex. 1.1. 1. The post-market surveillance plan drawn up in accordance with Article 84. The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83. (a) The post-market surveillance plan shall address the collection and utilization 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 88, 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 83, 84 and 86; 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 PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable. 1.2. 2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.

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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 … 5,055 unchanged words … for class IIa and class IIb 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 … 3,054 unchanged words … notified body 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 taken for certification such as application and application review.

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ANNEX VIII CLASSIFICATION RULES CHAPTER I DEFINITIONS SPECIFIC TO CLASSIFICATION RULES 1. DURATION OF USE 1.1. Transient means normally intended for continuous use for less than 60 minutes. 1.2. Short term means normally intended for continuous use for between 60 minutes and 30 days. 1.3. Long term means normally intended for continuous use for more than 30 days. 2. INVASIVE AND ACTIVE DEVICES 2.1. Body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma. 2.2. Surgically invasive device means: (a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and (b) a device which produces penetration other than through a body orifice. 2.3. Reusable surgical instrument means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. 2.4. Active therapeutic device means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability. 2.5. Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. 2.6. Central circulatory system means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior. 2.7. Central nervous system means the brain, meninges and spinal cord. 2.8. Injured skin or mucous membrane means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound. CHAPTER II IMPLEMENTING RULES 3.1. Application of the classification rules shall be governed by the intended purpose of the devices. 3.2. 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. Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right separately from the device with which they are used. 3.3. 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 … 2,326 unchanged words … and class IIb in all other cases. 7.9. Rule 22 Active therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators, are classified as class III.

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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(9) and maintain its effectiveness throughout the … 1,073 unchanged words … subcontractors to verify the manufacturing and other relevant processes. Moreover, in the case of class IIa and class IIb devices, the quality management system assessment shall be accompanied by the assessment of technical documentation for devices selected on a representative basis as specified in accordance with 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 105 and in particular the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended purpose and the results of any previous relevant assessments such as with regard to physical, chemical, biological or clinical properties, 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 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 IIa, class IIb and class III 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 … 453 unchanged words … 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 IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to specified in Sections 4.4 to 4.8 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 second third paragraph of Section 2.3. In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices. 3.6. The notified body 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 applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4) 4.1. In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for 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. 4.3. The notified body shall examine assess the application by technical documentation using staff, employed by it, staff with proven knowledge and experience regarding the technology concerned and its clinical application. The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of … 3,203 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.

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ANNEX XV CLINICAL INVESTIGATIONS CHAPTER I GENERAL REQUIREMENTS 1. Ethical principles Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical … 1,132 unchanged words … including length of time on the market and a review of performance, clinical benefit and safety-related issues and any corrective actions taken. 2.5. Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, side-effects, contraindications and warnings. 2.6. In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the … 1,695 unchanged words … conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation.