Annex viii classification rules. You must read carefully the definitions of . 1 Please consult Article 51 and Annex VIII of the MDR for classification rules This factsheet is aimed at manufacturers of Class I medical devices. g. These terms are: Transient means normally intended for continuous use for less than 60 minutes. The classification rules can be found in Annex VIII of the MDR. CHAPTER I DEFINITIONS SPECIFIC TO CLASSIFICATION RULES . This risk-based classification approach is reflected in the general provisions on the classification of medical devices laid down in Art. Special rules may apply to devices that already fall under any of the previous 3 categories, and therefore need to be always considered. 3. For the full text of the rules, see Annex VIII in the IVDR. Jan 10, 2024 · ANNEX VII – Requirements to be met by notified bodies; ANNEX VIII – Classification rules; ANNEX IX – Conformity assessment based on a quality management system and on assessment of technical documentation; ANNEX X – Conformity assessment based on type-examination; ANNEX XI – Conformity assessment based on product conformity verification Annex IV . They correspond, to a large extent, to the classification rules established by the Global Harmonization Task Force (GHTF) in the guidance document GHTF/SG1/N15:2006 Nov 6, 2023 · Since these tapes have direct contact with the surface of the body of the patient, they fall under the definition of a non-invasive medical device according to the MDCG Guidance on classification of medical devices (i. It covers devices that have already been placed on the market under Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance And lastly, there are also implementation rules which explain the classification under certain circumstances, e. Each device is classified by its manufacturer following a set of rules contained in the regulation. Now you should be able to determine the classification of the device. The classification rules should take into account the place where the device Jul 11, 2019 · Article 51 Classification of devices 1. Classification form according to Annex VIII of MDR (EU) 2017/745. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance) (revoked) Oct 5, 2021 · Th e MDCG has published a very important Guidance on classification of medical devices under the MDR – Regulation (E U) 2017/745: MDCG 2021-24. Details of the Medical Device classification in the EU MDR Aug 7, 2019 · Comparing classification rules MDD Annex IX, Rule 6 vs. All seven rules must be consulted to determine the device classification the applicable rule leading to the highest classification will apply to the device. EC declaration of conformity (Production quality assurance) • Annex VI . 1 to 1. Just download and go. All implementing rules, all classification rules, and all indents are to be considered to determine the classification of an IVD or an accessory for an IVD. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) (revoked) • Annex VI –European UDI System • Annex VII –Requirements to be met by Notified Bodies • Annex VIII –Classification Criteria • Annex IX –Conformity Assessment –QMS and Technical Documentation • Annex X –Conformity Assessment –Type Examination • Annex XI –Conformity Assessment –Product Conformity Verification Oct 4, 2021 · MDCG 2021-24 - Guidance on classification of medical devices. ‘Transient’ means normally intended for continuous use for less than 1. To obtain and define the correct product risk classification for a medical device, the duration of use is important. In EU MDR 2017/745, Annex VIII Classification Rules talks about Medical Device Classification. MDCG 2021-24, October 2021). Section 1. Notified bodies The regulation tightens the rules concerning how the independent notified bodies – which assess the conformity of medium- and high-risk medical devices before a8_003_1 Application of the classification rules shall be governed by the intended purpose of the devices. Class A non-sterile devices will be self-certified by This MEDDEV contains guidance for the application of the classification rules for medical devices as set out in Annex IX of Directive 93/42/EEC1, as amended. The document mainly analyzes the classification rules of Annex VIII of the MDR and most importantly provides examples for each Rule and the applicable classes. The intended purpose of the product, as determined by the manufacturer, is also important here. These concern the obligation to submit certain information on hazardous mixtures placed on the market, for emergency response reasons. Sep 4, 2020 · The Annex VIII of the MDR defines some terms on the classification. ‘Long term’ means normally intended for continuous use for more Jun 5, 2017 · • Annex VI – European UDI System • Annex VII – Requirements to be met by Notified Bodies • Annex VIII – Classification Criteria • Annex IX – Conformity Assessment – QMS and Technical Documentation • Annex X – Conformity Assessment – Type Examination • Annex XI – Conformity Assessment – Product Conformity Verification The MDR will contain 22 rules for classification – four more than the previous Medical Device Directive (MDD). Includes the complete Annex VIII (classification rules) of MDR EU2017/745 and helps to classify your devices. Essentially Implementing rules. Apr 22, 2021 · In order to help with classification, there are 22 EU MDR classification rules in Annex 8 for guidance. While not a surprise, RDC 751/2022 now incorporates as Annex I the 22 rules from the MDR. Jan 27, 2022 · Medical devices are classified according to their intended purpose and their inherent risks (classes I, IIa, IIb and III as set out in Annex VIII to the regulation). Dec 16, 2020 · Last November 2020, the Medical Device Coordination Group (MDCG) published the guideline MDCG 2020-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” to explain what are the classification rules of IVDs according to Annex VIII of the IVDR. The classification criteria (classification rules) are set out in Annex VIII of the Medical Devices Regulation (EU) 2017/745 (MDR) and Annex VIII of the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). These rules help manufacturers determine the appropriate class based on factors such as invasiveness, duration of contact, and impact on the body. 2. EC declaration of conformity • Annex VIII . 2 Device used in combination with another product Classification rules apply to each device separately. Hence, a review of the MDR risk classification changes (from the MDD) is a good preview of what to expect when the new Brazilian regulation becomes effective on March 1, 2023. They correspond, to a large extent, to the classification rules established by the Global Harmonization Task Force (GHTF) in the guidance document GHTF/SG1/N15:2006 Jul 8, 2024 · MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its third revision. ‘Transient’ means normally intended for continuous use for less than 60 minutes. You’ll find all those rules on the Medical Device Regulation MDR 2017/745 Annex VIII. The conformity assessment is driven by the device’s risk class, which is determined according to the rules in EU MDR Annex VIII, with the exception of those Annex XVI products reclassified under Regulation (EU) 2022/2347. For IVDR the corresponding references are Article 47 and Annex VIII. The criteria specified in this document shall also apply to applications (commonly referred to as apps), Implementing Rules (Annex VIII) 1. The risk posed by the device to safety outlines the four classes as follows: Feb 13, 2024 · The classification rules in Annex VIII of the EU MDR are divided into 4 subsections: non-invasive devices, invasive devices, active devices, and “special” rules. Mar 23, 2023 · Rule Six states that devices not covered by the previous rules are Class B. Classification shall be carried out in accordance with Annex VIII. 10 Annex VIII Classification Rule 1 & 2 Define Intended Purpose CDx assay intended for the qualitative detection of a specific protein associated with lung cancer in tissue , and is indicated as an aid in identifying patients eligible for treatment with crizotinibor ceritinib. Chapter 2: Implementing rules. Additionally, take a look into the MDCG 2019-11, Guidance on Qualification and Classification of SW in the Classification Rules –MDR, Annex VIII MDR MDD Rules 1 –4: Non-invasive devices Rules 5 –8 : Invasive devices Rules 9 –13 : Active Devices Rules 14 –22 : Special rules Rules 1 –4 : Non-invasive devices Rules 5 –8 : Invasive devices Rules 9 –12 : Active devices Rules 13 –18 : Special rules Form Ref: Using the Classification rules in Annex VIII Justin McCarthy Doc Ref: Using the Classification rules in Annex VIII Version No. To the extent necessary to resolve issues of divergent interpretation and of practical application, the Commission may adopt implementing acts, in order Now you should be able to determine the classification of the device. download full PDF document (02/05/2022) Additional information on the ECHA website Feb 2, 2023 · And, Annex IX was replaced by the new Annex VIII and 22 classification rules. Class I This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. Once manufacturers have defined the intended purpose and the IVDR codes of their in vitro diagnostic medical device, they can classify it according to Annex VIII Classification rules listed Annex VII: Requirements to be met by notified bodies; Annex VIII: Classification rules; Annex IX: Conformity assessment based on a quality management system and on assessment of technical documentation. Sep 2, 2022 · There are 22 classification rules in Annex VIII of MDR. IVDR Classification –Implementing Rules TÜV SÜD Product Service GmbH | Biocompatibility Compatibility Testing in Medical devices Annex VIII –Part 1 Impl. This is essentially a repeat of the principle stated in Section 1. The new Article 51 does however clarify, that where a Manufacture and Notified Body cannot agree on a classification, the Competent Authority of Manufacturer makes the final determination. Annex VIII Classification Rule 3 Jan 22, 2024 · Determining the class of medical devices under the MDR involves following the 22 classification rules outlined in Annex VIII. A CLH can be proposed for both substances without a current entry in Annex VI to CLP, and for Also, it must be noted that the MDR even contains items in Annex XVI that, while aesthetic or non-medical, with no medical purpose, still must comply with the MDR specifications. if your product is used in combination with another medical device, or if your product contains software (MDR 2017/745, annex VIII, chapter 2). MDR Annex VIII, Rule 6 regarding surgically invasive transient devices, the regulators have added the following statement (shown only in part for brevity) : "All surgically invasive devices intended for transient use are in Class IIa Jul 31, 2024 · Section 1: Classification of AI Systems as High-Risk Art. Definitions . Jul 28, 2023 · Article 47 of the IVDR briefly discusses classification, but Annex VIII contains the seven rules you will use to classify your device. e. Jul 25, 2019 · 5. The classification is therefore always determined for a concrete, individual product. 10 Data and Data Governance Art. 7. Class A non-sterile devices will be self-certified by Annex VIII contains the rules to be followed to determine the classification of the device and the two chapters are intended to be read and applied in sequence. Chapter I: Quality management system; Chapter II: Assessment of the technical documentation; Chapter III: Administrative provisions Annex VIII (List A) of the Basel Convention refers to those wastes which are characterized as hazardous under Article 1, paragraph 1 (a), of the Basel Convention, and their designation on this Annex does not preclude the use of Annex III to demonstrate that a waste is not hazardous. ; Short term means normally intended for continuous use for between 60 minutes and 30 days Jun 27, 2024 · Read Article 2 of the IVDR to verify if your software falls into the definition of an in-vitro diagnostic medical device, and continue with Annex VIII, Classification Rules. This is done through the harmonised classification and labelling (CLH) process. 1. com Annex XVI products should be classified in accordance with the classification rules in Annex VIII of the MDR and taking into account possible provisions within the relevant implementing acts covering Annex XVI devices. , duration, active, invasive) and outlines how the different rules should be implemented based on the intended use of the device. the transient, the short term and the long term use. CLASSIFICATION. EC verification • Annex V . Class IIb Annex VIII Rule 12 devices CE marking (Annex V) CE 2797 Annex X Type Examination Annex IX Chapter II Technical Documentation Jan 2, 2020 · The Medical Device Classification EU rules, which are based on the vulnerability of the human body, should take into account the potential risks associated with the technical design and manufacture of the devices. Sterile safety lancets would, most likely, be classified according to the rules in Annex VIII of the EU MDR (2017/745). Rule 1– Non-invasive devices Aug 14, 2019 · For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6. Annex VIII: Classification rules 1. Dec 14, 2023 · Unlike some countries and regions, the classification of devices in the EU is not decided by a central authority. MDR, Annex VIII(3. IMPLEMENTING RULES 1. According to the intended use, the medical device has an assigned duration of use. In the context of this Manual, classification cases are those for which the competent authorities of the Member States identify a difficulty in the uniform application of the classification rules. ANNEX VIII CLASSIFICATION RULES CHAPTER I DEFINITIONS SPECIFIC TO CLASSIFICATION RULES 1. Jan 11, 2024 · Section 1. In the MDD the rules could be found in Annex IX. Classification rules set out in Annex VIII to MDR apply to those products. They correspond, to a large extent, to the classification rules established by the In order to obtain a suitable risk-based classification of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body, it is necessary to introduce specific classification rules for such devices. However, Rule 11 gets the most attention in MDCG 2019-11, and for good reason. 7 Amendments to Annex III Section 2: Requirements for High-Risk AI Systems Art. Also Commission Implementing Regulation (EU) 2022/2347 applies for classification purposes of certain active devices without an intended medical purpose. 11 Technical Documentation Art. 1 DECEMBER 2021. Classification criteria • Annex X . In EU MDR Medical Device is Classified as following. ” Jan 28, 2022 · as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed Mar 27, 2023 · This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR by giving some examples and explanations of the IVDR classification rules. There are 10 Implementing Rules, but only 7 classification rules. Annex VIII contains the rules to be followed and the three chapters are intended to be read and applied in sequence. This Annex concerns the Medical Devices new classification rules that will be stricter than those currently stated in Annex IX of the Directive 93/42/CEE. 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. Chapter I: Quality management system; Chapter II: Assessment of the technical documentation; Chapter III: Administrative provisions May 7, 2024 · A medical device’s class can be determined if it satisfies the relevant rules contained in Annex VIII of the Medical Devices Regulation. AESGP Position Paper on Rule 21 concerns the classification on a case-by-case basis of medical devices composed of substances or of combinations of substances in accordance with the classification rule 21 set in Annex VIII of the Medical Devices Regulation (MDR) taking into account all their characteristics, including These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC. 2 of Annex VIII for a minimum period of five years. These rules and their corresponding applicable classes* are as follows: INTENTION OF Nov 4, 2019 · The European Commission’s Medical Device Coordination Group endorsed the related Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR which was made available at DG GROW’s website on 11 October 2019. Any dispute between the manufacturer and the notified body concerned, arising from the application […] Annex VIII Implementing Rules 1. These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC. Application of the classification rules shall be governed by the intended purpose of the devices. Jun 9, 2020 · The Voice of European Self-Care Industry. This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. The MDR provides 22 classification rules for medical devices, whereas the IVDR provides seven classification rules for in vitro Article 47 of the IVDR discusses the classification, and the rules themselves are laid out in Annex VIII. Details. Oct 4, 2021 · vast range of different medical devices and technologies. Foreword. Jun 3, 2023 · The EU MDR requires the same conformity assessment procedures for Annex XVI products as for other medical devices. 1. DURATION OF USE. Referring as necessary to the documents (a), (c) and (d) listed above, perform the following steps: There are seven classification rules which are explained in the Annex VIII. CHAPTER I. 4. Accessories for a medical device shall be classified in their own right separately from the device with which they are used. Class A is for low-risk products and Class D, as you smartly surmise, is reserved for high-risk products. Statement concerning devices for special purposes • Annex IX . Annex VIII has following chapters. tuvsud. The risk class of an IVD will determine its performance and safety requirements as well as its route to market. 3. application of Annex VIII to a given device, or category or group of devices, with a view to determining the classification of such devices (Article 47 (3-4) of the IVDR). The new IVDR separates devices into four classes: A, B, C, and D. While there is still no common EU medical device nomenclature ( Article 26 ), the rules are intended to sort out the medical devices into their proper classifications. Applying the 22 Classification Rules in Annex VIII for standard adhesive tape The classification is carried out according to the classification rules of Annex VIII of the MDR. ANNEX VIII. 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. a8_003_1 Application of the classification rules shall be governed by the intended purpose of the devices. Annex: Table for Determination of Medical Device Classification . Annex . This matters a lot because IVD companies are unique in that one technology or platform can easily be incorporated into hundreds of different products, which can trigger the need Class IIb Annex VIII Rule 12 devices Annex VIII Rule 12 devices – All active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body. DURATION OF USE 1. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. Rule Intended purpose of device Application of classification rules 1. Definitions specific to classification rules. Format: Microsoft Word (2010/2013/2016) Language: English (others available on reque Oct 28, 2019 · One of the main changes that will most affect the Medical Device regulatory field is included in Annex VIII of the new Regulation EU 2017/745 (MDR 2017/745). A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity; 7. Once classified, an IVD must undergo its applicable conformity assessment procedure for it to be CE marked and placed on the EU market. 2] of Annex VIII [F125, read with Regulation (EU) No 722/2012]; and (b) an undertaking to keep available for the Secretary of State the documentation referred to in Section 3. DURATION OF USE . See full list on de-mdr-ivdr. Aug 8, 2019 · Classification rules. They must be applied by all manufacturers, importers and downstream users of such substances and of mixtures containing them. Given the complexity of the topics, the Medical Device Coordination Group published a specific document entitled Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 to further explained the strategy for the Implementing rules. Therefore, referring as necessary to the documents (a), (c) and (d) listed above, perform the following steps: Implementing rules. They correspond, to a large extent, to the classification rules established by the Global Harmonization Task Force (GHTF) in the guidance document GHTF/SG1/N15:2006 Oct 6, 2021 · Dive Brief: The Medical Device Coordination Group has published an extensive guide to the classification of medical devices in the European Union. Risk class of the device in accordance with the rules set out in Annex VIII; 6. 10 of Annex VIII. These rules are a structured approach to assessing the potential risk posed by a device based on various factors. 4 (a) subject to paragraph (3), the statement required by [F124 Sections 1 and 2. Nov 29, 2019 · Below is a discussion of several key interpretative issues from the risk classification rules of the Regulation. Publication date. Annex VIII of the IVDR outlines these rules. 52 MB - PDF) Download. mdcg_2021-24_en. Article 47 of the IVDR discusses the classification, and the rules themselves are laid out in Annex VIII. This document defines the criteria for the qualification of software falling within the scope […] Implementing rules. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Implementing rules. The Provisions for Medical Device Classification promulgated on April 5, 2000 (Decree No. May 27, 2021 · approach classification of the devices with 4 classes: Class A devices being of lower risk and Class D being of higher risk. English (1. In the revision 2, the following items are changed: Rule 1, second indent: minor revision of examples Rule 2, class D examples: editorial change Jul 25, 2019 · 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. Yes: ☐ a8_003_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. The guidance provides clarifications on the classification rules listed in Annex VIII of the IVD Regulation. CLASSIFICATION RULES. 1 of Annex VIII of the IVDR makes clear straight away that Application of the classification rules shall be governed by the intended purpose of the devices. AESGP Position Paper on Rule 21. 2. This duration can be classified into 3 groups, i. Referring as necessary to the documents (a), (c) and (d) listed above, perform the following steps: Relevant IVDR Article and Annex: – Article 47 – Classification of devices – Annex VIII - Classification rules: i. placing on the market. Table for Determination of Medical Device Definitions of classification rules. 51 of the MDR, which states that devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks and the classification rules set in The classification is carried out according to the classification rules of Annex VIII of the MDR. The second update came in February 2023 with a flowchart to help determine whether an IVD is a companion diagnostic (CDx). medical devicea [Article 2(1)] and an Annex VII: Requirements to be met by notified bodies; Annex VIII: Classification rules; Annex IX: Conformity assessment based on a quality management system and on assessment of technical documentation. Below we provide some examples of the classification rules taken from the regulation, which classes they are related to, and their description. The risks of medical device software are often substantially different from those of a traditional hardware device; they are related more to the consequences of a failure to provide accurate information. Harmonised classifications are listed in Annex VI. Clinical Guidance on Annex VIII to CLP Description: This document provides guidance on the provisions of Article 45 and Annex VIII to CLP. Provides the rules by which classification should be carried out ii. EU Regulation 2017/745 regarding Medical Devices . 8 Compliance with the Requirements Art. 6 Classification Rules for High-Risk AI Systems Art. This states: Each of the classification rules shall apply to first line assays, confirmatory assays and supplemental assays. ; Across the 57-page document, MDCG sets out how to classify medical devices, provides rules to inform the process and describes the impacts of the classification on pre- and postmarket regulatory requirements. It is for the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis. These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). Annex VIII provides definitions that are specific to the classification rules (e. ‘Short term’ means normally intended for continuous use for between 1. 9 Risk Management System Art. The rules to be followed in determining the classification are contained in Annex VIII in the new EU MDR (replacing Annex IX of the current MDD. The application of these classification rules is based on intended purpose and inherent risks posed by the IVD. EC declaration of conformity (Product quality assurance) • Annex VII . ANNEX VIII CLASSIFICATION RULES 1. Regulation (EU) 2017/746 of the European Parliament and of the Council Show full title. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12 Mar 3, 2023 · Rule 11 of Chapter III in Annex VIII of the MDR contains the following provisions: “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: Jul 14, 2015 · Article 10 The Rules shall be effective as of January 1, 2016. 15 of the former State Drug Administration) is annulled simultaneously. 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. Chapter 1: Definitions specific to classification rules. This classification guidance also applies to May 14, 2024 · Classification. 12 Record-Keeping CLASSIFICATION RULES UNDER THE IVDR The IVDR provides seven rules which are used to classify an IVD and are set out in Annex VIII of the Regulation. Chapter 3: Classification rules . Step 2: Refer to Annex VIII of MDR: Annex VIII of the MDR contains detailed classification rules that outline the criteria for each class of medical device. pdf. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity; Regulation (EU) 2017/745 of the European Parliament and of the Council Show full title. The criteria specified in this document shall also apply to applications (commonly referred to as apps), These are referred to as the ‘classification rules’ and are set out in Annex IX of Directive 93/42/EEC. 1 Application of the classification rules shall be governed by the intended purpose of the devices. The post-market surveillance plan drawn up […] devices and Annex VIII Classification rules. Rule Seven states that devices which are controls without a quantitative or qualitative assigned value are Class B. All of the rules are based on the potential risks associated with the device, its technical design, and how the device is manufactured. 0 page 1 of 2 Using the Classification rules in Annex VIII . hqqybm dqc pbe eiibg qbivxy zjigi urxy bnlquv dhfypl pii