Eu medical device classification rules

Eu medical device classification rules. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. The classification rules are detailed in the EU medical device regulation, the European Medical Device Regulation 2017/745 . Chapter 1: Definitions specific to classification rules. , – Class IV) in Canada than it is in Europe (i. in sections 3. Background note on the use of the Manual on borderline and classification for medical devices under the Directives. The MDCG has published guidance on the classification of medical To stipulate a series of principles and rules that allow a medical device to be assigned to one of four classes based on its intended use, and thereby: assist a manufacturer to allocate its medical device to an appropriate class using a set of classification rules; and Not all medical devices are the same. Last week, I was visiting a client who was told that their device is a higher risk device classification (i. Jan 22, 2024 · The MDR medical device classification is based on the device’s potential risk of harm to users. 1 Guidance on standardisation for medical devices. Both rules lead to classifying all coronary stents as class III medical devices. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U. Special rules may apply to devices that already fall under any of the previous 3 categories, and therefore need to be always considered. Apr 6, 2022 · The European Union’s new In Vitro Diagnostic Medical Device Regulation (IVDR) becomes law near the end of May this year, replacing the previous regulatory regime, the In Vitro Diagnostic Medical Device Directive (IVDD). To classify your medical device, follow these steps: Decide what type of device you have: non-invasive, invasive, active, or special medical device. How are devices classified in the EU? Medical device classification is rules-based and simple to follow: There are 22 rules that guide your device’s classification (Annex VIII of EU MDR 2017/745), which Jan 23, 2020 · Classification Rules (Annex VIII) There are 22 classification rules in total – some of which have been updated and the inclusion of four new rules. 3 Guidance on Classification Rules for in-vitro Diagnostic Medical Devices for Regulation (EU) 2017/746 i MDCG 2020-16 rev. 2 and 4. Additionally, proper classification is important to determine the conformity The medical device class can be determined using the classification rules laid out in Regulation (EU) 2017/745 or the European Directive applicable to medical device technology. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Classification approach – EU 2017/746 Sep 18, 2013 · Author reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents. The safety and effectiveness evidence required to support a medical device licence application is proportional to the risk of the device, which is determined by applying the Classification Rules for Medical Devices detailed in Schedule 1 of the Regulations. 2. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications and Nov 6, 2023 · The MDR introduced four additional ru les, to bring the total number of rules to 22, to help enforce a more conservative approach to classification by considering long-term use, safety, efficacy, invasiveness, pharmacological effect, software as a medical device, etc. Each regulatory agency has defined several different medical device classes. Under the In Vitro Diagnostic Regulation that takes effect in 2022, IVDs sold in Europe will be put into four risk categories that dictate what requirements apply to them Definitions, of EU MDR 2017/745 (Medical Devices) for aspects to consider regarding Intended Use. Oct 4, 2021 · These are referred to as the ‘classification rules’ and are set out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR). This page provides an overview of the medical device classification and reclassification processes and includes links to tables that give details about the medical devices reclassified by the FDA Jun 26, 2022 · 5. Read here how these rules are broken down and find explanations on under which rules medical devices might fall. Oct 4, 2021 · MDCG 2021-24 - Guidance on classification of medical devices. Implementing rules. In Annex VIII of the MDR, you’ll find 22 rules for classifying any medical device. Jul 29, 2024 · The main difference between EU MDR and FDA for connected devices is the classification process itself. Chapter 2: Implementing rules Oct 4, 2016 · device classification rules (Part II of the UK MDR 2002, Annex IX [as modified by Part II of Schedule 2A to the UK MDR 2002]) guidance document MEDDEV 2. Instead, the MDR allows for a systematic approach to identifying the appropriate class using the Classification Rules of Annex VIII, which are split up into 4 sections: Non-Invasive Devices [Rules 1-4] Invasive Devices [Rules 5-8] The risk is incremental from class 1 to class III. The rules for medical device classification are separated into the following categories: Non-invasive medical devices The below classification tool can be used to assess the risk classification of your medical device under the EU Medical Device Regulation (MDR) 2017/745. Food and Drug Administration (FDA) and EU requirements are not the same. ‘Transient’ means normally intended for continuous use for less than 60 minutes. Classification is determined based on the device’s intended use, characteristics and inherent risks. Here certain device types are mapped to the classes I, IIa, IIb or III. Classification and labeling rules in the EU are complex, and Intertek has the expertise to guide you through those complexities. If there isn’t a predicate, you have a more extensive approval process through FDA. In doing so, manufacturers should be aware that these risk classes may differ from the class assigned under the MDD, e. May 7, 2024 · The European Commission published a guide on the classification rules, which includes examples of products related to each rule. The risk level is dependent on the intended use, effectiveness of risk management techniques applied during design, manufacture and use, its intended user(s), mode of operation, and technologies used. While the EU’s classification system shares some similarities with the FDA’s, it has distinct differences. A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in the Classification Rules for Medical Devices. Quality System requirements to maintain compliant Validations. Rule 1– Non-invasive devices. needs further updates (esp. The MDR adds four additional rules to this scheme. Where a device has more than one specified purpose, the correct result will be based on the purpose with the highest classification. ‘Long term’ means normally intended for continuous use for more than 30 […] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification – MDCG. Brazilian regulators align medical device classification rules to those of EU MDR Feb 10, 2023 · Update - MDCG 2020-16 Rev. First, a manufacturer needs to determine if their product aligns with the definition of a medical device as stated in MDR Article 2. The classification procedures in Canada and the EU are quite similar―manufacturers must classify their medical devices according to the rules and criteria set out in the relevant medical device regulations (Canada) and directives (EU), as indicated in Table 1. It is based on the classification rules detailed in Annex VIII of the MDR, along with the information included in MDCG guidance 2021-24 (‘Guidance on classification of medical devices Mar 26, 2024 · While this now aligns EU IVD classification with the GHTF/IMDRF principles of IVD classification and similar classification systems used in other well-established markets, manufacturers without previous experience in such systems may be unsure on how to appropriately classify their devices. Dec 13, 2023 · How does the EU classify medical devices? There are 22 rules in Annex VIII of the European Medical Devices Regulation (MDR) used to determine the medical device risk classification in the EU. Each medical device could be assigned only to one class. The classifications are, for the most part or as a general rule, related to the perceived risk of the product type. Medical devices are products or equipment intended for a medical purpose. S. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. The classification determines the conformity assessment route for the device. In EU MDR 2017/745, Annex VIII Classification Rules talks about Medical Device Classification. com 10FL, Kyobo Securities Building,97, Uisadang-daero, Yeongdeungpo-gu, 07327, Seoul, Korea +82 (0) 2 6336 6763 Apr 22, 2018 · EU Medical Device Classification by Easy Medical Device Medical Device Regulation 2017/745 22 18 Difference of rule number between MDD 93/42/EC and MDR 2017/745 # of rules 93/42/EC 2017/745 Duration of use ‘Transient’ means normally intended for continuous use for less than 60 minutes. 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. Update of MDCG 2021-5 Rev. European Medical Device Regulations (MDR’s). Medical devices are classified into four risk groups, according to the classification rules: I, IIa, IIb, and III (depending on the risk during use). The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. EU medical device classification includes four Article 51 requires all medical devices to be classified into one of four classes. 2 It is considered more feasible, economically and justifiably, to categorize medical devices rather than all of them being subject to the rigorous conformity assessment procedures. Article 51 requires all medical devices to be classified into one of four classes. 4 (rule 8) and for DES also Annex IX, Chapter III, Section 4. The rules are divided into four sections, and the rules of each section apply to a specific category of devices. The classification rules can be found in Annex VIII of the MDR. , devices may Update of MDCG 2020-16 Rev. Application of the classification rules shall be governed by the intended purpose of the devices. Nov 24, 2020 · In addition, given how much medicine has advanced in the past 30 years, it is logical that the regulations that allow medical devices to be placed on the EU market should be adjusted accordingly. This guidance provides practical information on the application of IVDR classification rules for manufacturers. Classification shall be carried out in accordance with Annex VIII. Annex VIII has following chapters. Jul 8, 2024 · MDCG 2020-16 Rev. Apr 23, 2015 · The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. • An accessory to a medical device is classified separately from the medical device; and • If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device. The MDD and MDR both use a rule-based medical device classification pattern. Understanding these rules empowers manufacturers to navigate the complexities of compliance and bring safe and effective devices to the market. Nov 17, 2023 · In addition to the definition, the MDCG writes: Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. U. May 1, 2024 · The EU uses a rules-based system for determining the risk class of a medical device. The reason given is: the section related to E. English. Accessories for a medical device and for a product listed in The Malaysian Medical Device Authority (MDA) created a classification system based on Medical Device Regulation 2012 which is closely aligned with the ASEAN MDD. 2. Mar 8, 2024 · According to the definition of a medical device, every medical device must have a “specific medical purpose“. The manufacturer is responsible for Apr 22, 2021 · Three steps for classifying a medical device under the EU MDR. Confirmation of conformity with the requirements concerning the characteristics and performance Device classification. 1 DECEMBER 2021. Guidance on classification of medical devicesOctober 2021This document has been endorsed by the Medical Device Coordination Group (MD. K. FDA Medical Device Classification. Understanding this system, governed by the EU Medical Device Regulation (EU MDR 2017/745), is essential. Jul 11, 2019 · Article 51 Classification of devices 1. Based on the class and the 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. 1. Medical Device Process Medical Device Classification in the EU MDR - European Medical Device Regulation 2017/745 - A complete guide to understand the classification of devices Skip to content info@kobridgeconsulting. Look at each classification rule from the first to the last (Rules 1–22). and EU device classes are based on risk, U. The determination of the EU MDR medical device classification and the corresponding rule is the first step in the EU CE marking process. However, if you read through MDR 2017/745 and all relevant MDCG documents, you will find a lot of information helping you to set the correct classification. Work through the classification rules step by step in order to arrive at a classification that best describes to the device under consideration. In this article, we will review the outline of the must-know legislation for medical device registration in the EAEU: EAEU legislation for medical devices; Medical device regulations in the EAEU and Russia; Risk Classification in Russia, EAEU and EU; Transition period; Medical device dossier in the EAEU Mar 14, 2021 · In accordance with the updated classification rules, all medical devices are divided into 4 classes depending on the potential application risk (1, 2a, 2b, and 3 respectively). In Article 51 and in Annex VIII of Regulation (EU) 2017/745, the classification principles are laid down in great detail. Medical Device Medical Device Coordination Group Document MDCG 2019-11 MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR October 2019 This document has been endorsed by the Medical Device Coordination Group 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. ‘Short term’ means normally intended for continu Nov 13, 2020 · Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 News announcement 13 November 2020 Directorate-General for Health and Food Safety 1 min read 8 JULY 2024 Classification rules - MDD • The current Directive 93/42/EEC classification rules state under Rule 18 that: “By derogation from other rules, blood bags are in Class IIb. For instance; The classification structure is a better match to clinical practice; Additional product key info better identifies and describes each medical device Jul 14, 2015 · Article 9 The China Food and Drug Administration may organize a medical device classification experts committee to formulate and adjust the medical device classification catalogue. For all devices, manufacturers shall draw up an EU Declaration of Conformity. Rules of classification. 1 Application of the classification rules shall be governed by the intended purpose of the devices. They correspond, to a large extent, to the classification rules established by the International Medical Device Regulators Forum (IMDRF) in the guidance document GHTF/SG1/N77:20121. It was therefore decided to set up a system of classification rules within the Directive, so that each manufacturer could classify its own devices. G) established by Article 103 of Regulation (EU) 2017/745. 4 If a dispute arises between a manufacturer and an Approved Body over the classification of a medical device, the MHRA can determine the classification of the device (under regulations 7(2) or Aug 27, 2024 · Understanding the EU MDR classification rules is essential to ensure compliance with regulations to obtain a CE mark and legally commercialize your device in the European market. QSR’s. MDR Class IIb medical devices contain contact lenses 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. Now all the medical devices need to be reassessed for compliance and certification. History of the Medical Device Directive Jun 17, 2022 · The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been set back one year to May 26, 2021. (5) To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection What You Need to Know About Regulation (EU) 2017/745 Changes in the classification of devices The MDR introduces new classification rules, based on which manufacturers must determine the risk class of their devices. Regulators do this with a classification system. In Medical device classifications in Singapore are generally aligned with classifications in the European Union; however, IVD classification is not reflective of the EU but is more closely aligned with Canada or Australia. The additional criteria to be considered when determining the appropriate classification of a medical device Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Page 4 of 44 Depending on the nature of the condition and the targeted patie nt population, screening devices may be used routinely or may be restricted to "at risk". (Rules 1-4:Non-invasive devices, Rules 5-8:Invasive devices, Rules 9-13:Active devices, Rules 14-22:Special rules (Rules 19-22 are new rules)). Classifying your medical device can seem like an overwhelming task, especially if you have a more advanced product. Will the new Medical Device Regulation (MDR) affect classification rules in Europe? The MDR will revise classification rules and conformity requirements for specific products, such as some class II implants and substance-based devices. Diagnostic devices sold in the European Union (EU) will face a new regulatory classification system with new categories Jan 31, 2024 · 1. Learn more at Emergo by UL. Most devices in the US get to market via the 510(k) pathway, so device classification is determined by finding a predicate device and matching the class. The rules that apply to your medical device depend on how your product is classified by the regulatory agencies. 15 of the Jan 28, 2020 · Classification of medical devices in the EU uses a rule-based system. classification rules for these devices are Annex IX, Chapter III, Section 2. Apr 26, 2024 · Rules Applicable; 3. However, because in vitro devices are used with biological material that has been removed from the body, they may also pose a risk to public health due to transmissible agents Devices must be correctly classified using MDR classification rules. Apr 2, 2024 · Medical device regulatory classification. Non-invasive devices are covered by rules 1-4, while invasive Mar 23, 2023 · Under the IVDR classification system, IVD devices are grouped by risk, similar to how other medical devices are grouped under the EU Medical Device Regulation (EU MDR). The regulatory When compared with the previous classification system, China Med Device believes NMPA (CFDA)’s 2018 medical device catalog revisions brought in several advantages. developed their own Apr 9, 2021 · Successfully bringing a medical device to the European Union (EU) market begins with classifying it correctly. 3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. Invasive medical devices Step 1: Classify the medical device. Once classified, an IVD must undergo its applicable conformity assessment procedure for it to be CE marked and placed on the EU market. There are seven Classification rules. ) Like the MDD, the MDR has four main risk-based categories for medical device classification: Mar 3, 2023 · Rather, two cases must be distinguished for classification according to MDR (not classification as a medical device): The software “drives a device or influences the use of a device”: the classification of the software corresponds to that of the “influenced medical device independent of Rule 11. Aug 8, 2019 · Classification rules CHAPTER I Definitions specific to classification rules 1. 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. 3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 July 2024 Apr 17, 2024 · The classification rules can be found in Annex VII of Regulation (EU) 2017/745 on medical devices (MDR). Directive 93/42/EEC, as amended, allows for derogation from the Medical Device Coordination Group Document MDCG 2020-16 rev. 1 (rule 13). Reference Title Publication; Manual on Borderline: Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3. The manufacturer is responsible for determining the classification of the device. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. 3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 July 2024 Medical device classification. The selection of risk classification is not done arbitrarily based on a sense of the overall risk of the device. DURATION OF USE 1. Guidance on classification rules for IVD under the IVDR (pending) – MDCG 2019-11 . All medical devices are placed into one of four graduated categories, using the classification rules listed in Directive 93/42/EEC Annex IX. Consider These Questions Prior to Classification Review Nov 4, 2021 · The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the applicable classification rules. 3. Nov 16, 2020 · The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework for medical devices, has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Medical Devices Classification. Article 10 The Rules shall be effective as of January 1, 2016. To view the guide, enter into the European Commission’s site containing guidance documents concerning the Medical Devices Regulation and search for the document entitled “Guidance on classification of medical devices”. Yes: 3. 3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024 Feb 2, 2023 · Brazilian medical device classification rules under RDC 751/2022 reflect changes under the European Medical Devices Regulation (MDR). 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. Examples of EU MDR Class I medical devices include hospital beds, corrective glasses, and thermometers. Jul 1, 2024 · Some things to note before you start. FDA Medical Device Regulation. 4 new rules came in the game. Guidance document MDCG 2021-24 contains 22 rules that focus on a specific medical device category. Likewise, unfortunately, no blanket decisions can be made on entire product groups, as the risk classification always depends on the individual intended purpose and the corresponding information provided by the manufacturer. The MDCG is composed of representatives of all Member States and it. EU MDR MEDICAL DEVICE CLASSIFICATION. It is for the national Competent Authorities and national Courts to take legally binding decisions on a case-by-case basis. EU Medical Device The Federal Institute for Drugs and Medical Devices (BfArM) does not have a list of product classifications of medical devices marketed in Europe. The MDCG has published Guidance on Classification Rules for in vitro Diagnostic Medical Devices. Any dispute between the manufacturer and the notified body concerned, arising from the application […] Sep 4, 2020 · The Medical Device Regulation (MDR) EU 2017/745 defines in its Annex VIII the classification rules for medical devices. e. The Provisions for Medical Device Classification promulgated on April 5, 2000 (Decree No. Rules 1-4 cover non-invasive devices. The classification then needs to be determined in accordance with Article 51 and the rules contained in Annex VIII. Let’s discuss in detail about the Classification Rules as per EU MDR 2017/745. Nov 16, 2020 · The European Commission's Medical Device Coordination Group has published guidance on the classification rules for in vitro diagnostics under the incoming regulations. 2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023 Then read through the Classification rules (Chapter II). All of this has led to the creation of a new regulation for medical devices – the EU Medical Device Regulation. FDA cGMP’s. An IVD medical device has the medical device classification applying under the classification rules set out Jul 12, 2021 · The new EU Medical Device Regulations (MDR) and in vitro Diagnostic Regulation (IVDR), 2017 make notified bodies, competent authorities and the European Commission more responsible than ever before for the safety of medical devices, including in vitro Diagnostics. The MDR classification rules lay the foundation for a harmonized and effective regulatory framework for medical devices within the EU. Oct 6, 2021 · The Medical Device Coordination Group has published an extensive guide to the classification of medical devices in the European Union. However, you should not assume that your CE marking classification will be the same in Canada as in other jurisdictions. The amending EU-MDR Regulation 2020/561 offers a wealth of detail impacted manufacturers should understand and act on now. IMPLEMENTING RULES; 3. 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. Medical Device Coordination Group Document MDCG 2020-16 rev. ” • Rule 13 MDD states: All devices incorporating, as an integral part , a substance which, if used separately, can be considered to be a medicinal The Canadian classification rules for medical devices are very similar to those in the EU Medical Devices Directive / Regulation. 3. Current Good Manufacturing Practices. . 1. EU MDR’s / MDD’s. The device classification is the highest class determined by these rules. 4/1 rev 9 – Classification of medical devices This article needs to be updated. Once a device is correctly classified, it must undergo its applicable conformity assessment procedure in order for it to be CE marked and placed on the EU market. Jul 26, 2024 · The Medical Device Regulation 2017/745 (MDR) implemented in the European Union (EU) describes how medical devices are classified using rules based on the regulatory obligations associated with the medical device. Chapter II: Implementing rules. pdf. Devices can be described as falling into one of four categories separate from their risk-based class: Non-invasive medical devices . In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. mdcg_2021-24_en. Nov 11, 2021 · A comprehensive guide to medical device classification EU was published on October 20, 2021 by The Medical Device Coordination Group (MDCG). EU medical device classification FAQs. 2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. MDCG guidelines are detailed in a 57-page document, detailing how medical devices are classified, and providing rules to help in this process. The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. g. Medical devices are classified according to their intended purpose, as specified by the manufacturer. Apr 12, 2020 · As you may see, the number of rules for the EU Medical Device Classification increased between the MDD 93/42/EC and the EU MDR 2017/745 (Participate to the free mini-course). Finally, it is important to document the decision on the classification and the supporting justification. 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. EU Medical Device Regulation and Classification (per MDD’s). The 4th indent of the definition of a medical device specifies “providing information by means of in vitro examination of specimens derived from the human body […]” as a medical purpose and thus refers to in vitro diagnostics (IVDs), which are a subgroup of medical devices. , – Class IIa). 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 classification 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. If you think multiple rules apply, you should go with the It was therefore decided to set up a system of classification rules within the Directive, so that each manufacturer could classify its own devices. Annex VIII of the MDR outlines these rules. In the new MDR, there are now 22 rules in Annex VIII. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. The rules for dangerous substances are defined in 67/548/EEC and its amendments, and the rules for dangerous preparations are defined in 1999/45/EC, as last amended by 2006/8/EC. (IVDs have their own classification scheme under the IVDR. While classification is primarily the concern of the manufacturer, if the device falls into Classes IIa, IIb or III it has implications for the Notified Body. MDR Class IIa medical devices contain catheters, hearing aids, and surgical clamps. While both the U. qsodx olpypo zfgpraw rzyeuh scf iuek ttq kszqb oalyk tth