Medical device definition eu (5) Soweit möglich sollten die auf internationaler Ebene, insbesondere im Rahmen der „Global Harmonization Task Force“ (GHTF) und deren Folgeinitiative, des Internationalen Forums der Aufsichtsbehörden für Medizinprodukte (IMDRF — International Medical Devices Regulators Forum), entwickelten Leitlinien für Medizinprodukte berücksichtigt werden, damit die internationale Angleichung Defining the intended purpose of the future planned device is the starting point for all decisions, including whether the product is a medical device or not. U. A slight difference exists between the definition in article 1(2) (a) of Directive 93/42/EEC and in These regulations introduce more stringent procedures for conformity assessment and post-marketing surveillance, require manufacturers to produce clinical safety data, establish a unique device identification system for the traceability of devices and provide for the setting up of a European database on medical devices. May 7, 2024 · The European Commission published a guide on the classification rules, which includes examples of products related to each rule. 5. These devices also require a technical file, as well as an application to a EU notified body for manufacturing certification in accordance with sterility requirements. The FDA’s definition includes all devices that are used to treat animals as well. ‘Long term’ means normally intended for continuous use for more than 30 […] This article needs to be updated. EU MEDICAL DEVICE REGULATION (MDR) The final MDR document was published in May 2017, and the regulations will come into force in May 2021. ” Current regulatory classifications of medical devices are complex and designed primarily for regulators. of high-risk medical devices and . Regulation (EU) 2017/745 Medical Device 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 Active Implantable Medical Devices Directive (EU AIMDD) and 93/42/EEC Medical Device Classified as public by the European Medicines Agency . 28. Expert Panels – advisory role (ad hoc . It is a set of regulations that govern the safety and performance requirements of medical devices in the European market. in sections 3. May 1, 2019 · With the implementation of the EU Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture devices are wondering if they will be considered the “legal manufacturer” of the device they sell. K. Examples include products for cleaning, disinfection or sterilization of devices as well as contact lenses, liposuction equipment, or epilation lasers. activities) • To the Medical Device Coordination Group (MDCG) and the European Commission concerning . 1 How the EU regulations came about. 2017/745 (for medical devices or active implantable medical devices (MDs)) and In Vitro Diagnostic Device Regulation (IVDR) No. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and Dec 18, 2019 · A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Guidance is also available from the Medical Device Coordination Group: MDCG-27 Rev1 Questions and Answers on Articles 13 (Importers) & 14 (Distributors). Medical Device Definition A medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific Sep 6, 2024 · 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. Sep 16, 2022 · Last, if your product falls under the definition of a medical device in EU MDR Article 2(1) and/or the definition of a IVD in IVDR Article 2(2), it may be excluded from their scope and be governed by a different regulatory regime. Medical device companies can receive compliance. In Europe, IVD follows another regulation even if it is called In-Vitro diagnostic medical devices. 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. The European Union (EU) Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the EU. Information & Training. MDCG 2022 – 5 Rev. Background information on the EU Medical Device Regulation 4. Define EU Medical Device. A medical device must have a medical purpose. MDR 2017/245 covers devices that were previously under the scope of two separate European directives: Medical Devices Directive (MDD 93/42/EEC) Jul 12, 2021 · The FDA includes IVD into the definition of a medical device. The vigilance requirements in Medical Device Regulation (MDR) No. developed their own If the answer is yes to question 5, the product fulfils the definition of an in vitro diagnostic medical device, Regulation (EU) 2017/746 applies and not Regulation (EU) 2017/745. See below a summary of the information to be included to comply with EU MDR Technical Documentation. Aug 8, 2019 · Classification rules CHAPTER I Definitions specific to classification rules 1. ‘Transient’ means normally intended for continuous use for less than 60 minutes. The new Regulations will create a robust, transparent, and sustainable regulatory The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. Mar 5, 2025 · “Some 3PL companies which provide transportation services or hold devices on a consignment basis only (i. 1. What is a Medical Device? The definition of medical devices is reported within Article 2 of the EU MDR 2017/745: medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: Jan 19, 2016 · Pining a definition to the term ‘medical device’ has never been easier since the introduction of Medical Device Directive 93/42/EEC. ; MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Therefore, it is largely unclear who initiated the new regulation and for what reason. 1 of the MDR) Let's start with the definition of a medical device (2017/745/EU). Jul 16, 2019 · Article 87 Reporting of serious incidents and field safety corrective actions 1. g. 2 and 4. The three classes are: Class I Jan 3, 2020 · This post is about the fundamental definitions of a medical device product and an in-vitro diagnostic (IVD) medical device product in the European Union (EU) market under the medical device regulation (EU) 2017/745 (MDR) and the in-vitro diagnostic medical device regulation (EU) 2017/746 (IVDR). For medical device companies, if you want to enter both the US and EU markets, then you need to be very aware of the similarities and differences between Aug 25, 2016 · 1. where devices are held at a site by the 3PL, but the 3PL does not have legal ownership of those devices), may not be considered an importer provided there is a clearly defined agreement between both parties setting out the Jul 27, 2022 · The European Union’s Medical Device Regulation (MDR) took effect in May 2022, intending to remove ambiguity in medical device manufacturing, alleviate subjective regulatory approvals and prioritize patient safety. There could be other definitions of medical devices on other markets around the world, meaning that a product that is considered a medical device in the US might not be considered a medical device in the EU. substances). Medical devices are very wide-ranging products, such as apparatus/instruments, software, and materials (i. safety and performance. Page . In Europe, this isn’t the case. The MDD is based on the principles of the “New Approach to Technical Harmonization and Standards” , a common set of regulations in the EU that standardizes technical requirements, testing and certification procedures. 1 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745. ” May 31, 2021 · By Mark Durivage, Quality Systems Compliance LLC. 1 Definition of medical device and medicinal product . 2. According to the Medical Devices Regulation (EU) 2017/745 (MDR) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: Medical Device Coordination Group Document. The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. During the transition period, devices may be placed on the market under either AIMDD/MDD or EU MDR. com 10FL, Kyobo Securities Building,97, Uisadang-daero, Yeongdeungpo-gu, 07327, Seoul, Korea +82 (0) 2 6336 6763 Jun 17, 2022 · The definition of medical device will be broadened to include non-medical and cosmetic devices not previously regulated. Sep 20, 2023 · Conditions for Placing a Medical Device on the Market. Medical devices are assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States based on their role and expertise in the field of medical devices including in vitro diagnostic medical devices, should be established to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/746 of Class Is Devices: Class I devices placed on the market in sterile condition. , single-use consumable), 2) the device expires (e. The placing of a medical device on the market is conditional on obtaining the CE marking prior to its marketing. Class Im Devices: Class I devices with a measuring function. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U. The definitions of medical device and medicinal product are reproduced here for reference: 1. | Medical Devices. The European Medical Device Regulation 2017/745 requires the compilation of technical documentation. The MDR medical device classification is based on the device’s potential risk of harm to users. The formal definition of an accessory for a medical devices is: MDR, Article 2(2): ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their For a product to qualify as a medical device in the EU, it must meet the definition in Article 2(1) of the EU Medical Device Regulation 2017/745. 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. It is often claimed that the breast implant scandal triggered the revision of medical device legislation. 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”. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Introduced on June 14, 1998, and amended on September 5, 2007, the directive came into effect in March 2010 and established the essential requirements and harmonized standards for the manufacture, design, and The European Union Medical Device Regulation 2017/745 (EU MDR) defines medical device as, “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: May 14, 2024 · Formal Definition. May 14, 2025 · The European Union Medical Device Regulation (EU MDR), formally known as Regulation (EU) 2017/745 or EU MDR 2017/745, governs all medical devices within the EU. Dec 16, 2019 · We propose the following definition of a medical device: “A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional. 1 Definition of medical device (Article 2 (1) MDR) ‘medical device’ The definition of Medical Device (MD) is given in the European Regulation (EU) 2017/745 (MDR : Medical Devices Regulation) which defines the regulatory framework to ensure the safety and performance of products and a favorable benefit/risk ratio. Feb 4, 2025 · 4. To comply with EU legal requirements, any medical device on the market must be considered “state-of-the-art. Properly described, the intended purpose will provide; (a) confirmation, or not, of whether the product being considered fits the definition of a “medical device” and therefore whether 1 Purpose of medical device classification. The terms expected lifetime and useful life are generally synonymous. needs further updates (esp. 1 . Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of Dec 8, 2021 · Please note that this was all for the definition of a medical device in the European Union. e. diagnostics • To contribute to the development and maintenance of Understanding the Differences Between MDD vs MDR - European Medical Device Regulation 2017/745 vs Medical Device Directives Skip to content info@kobridgeconsulting. Compared to the Medical Device Directive (MDD), the EU MDR introduces stricter requirements for risk management, technical documentation, clinical evaluation, post-market surveillance The European Commission is responsible for regulating medical devices in Europe. In order for a product to qualify as a medical device, it must meet the definition outlined under Article 2(1) of the Medical Devices Regulation (MDR). Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any serious incident involving devices made available on the Unionmarket, except expected side-effects Sep 6, 2021 · This revised article considers the definition of a medical device and explore the types of products that may fall in under the classification of a medical device post May 2021. Definition of medical device (Article 2. The expected lifetime is how long the device is anticipated to safely meet its intended purpose. Introduction. Aug 6, 2024 · European jurisprudence consists of, firstly, the medical device directives that have to be transposed into national (medical device) law, and the EU medical device regulations (MDR, IVDR). means the European Union regulatory framework ensuring the safety and efficacy of medical devices and facilitates patients’ access to devices in the European Union market, including 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 Update of MDCG 2022-5 rev. , a liquid based Oct 13, 2023 · Medical devices (MD) are classified according to the rules defined in Appendix VIII of European regulation MDR 2017/745. Various definitions for the expression ‘medical device’ coexist according to regulations in the United States, European Union (EU), and Japan. Definition of medical device. Oct 24, 2023 · Expected Lifetime / Useful Life. The marking reflects the conformity of the medical device with the These regulations introduce more stringent procedures for conformity assessment and post-marketing surveillance, require manufacturers to produce clinical safety data, establish a unique device identification system for the traceability of devices and provide for the setting up of a European database on medical devices. Oct 19, 2023 · EU MDR stands for European Union Medical Device Regulation. of . Aug 25, 2016 · 1. Besides “What does MDR stand for?”, many other questions need to be answered to show you the big picture of the EU Medical Device Regulation. The new Medical Devices Regulation (2017/745/EU) (MDR) and the In-vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, chang-es in medical science, and progress in law making. The manufacturer shall develop technical documentation for each of its devices. MDCG 2021-24 - Public Health Medical Device Lifetime: Addressing the lifetime requirements of the MDR (EU) 2017/745 4 Definition of lifetime Basic principles The MDR does not define medical device lifetime in a specific manner, and there is no consistent definition used in standards or guidance documents, which may lead to uncertainty for devices with a shelf life and Qualification of medical devices. 2017/746 (for in vitro diagnostic (IVD) devices) include notification and evaluation of serious incidents and field safety corrective actions (FSCAs Jan 22, 2024 · The European Union Medical Device Regulation (EU MDR) categorizes medical devices into one of four classes: Class I, Class IIa, Class IIb, and Class III medical devices. (New) First publication of MDCG 2024-13 - Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. Classification is determined based on the device’s intended use, characteristics and inherent risks. Apr 21, 2025 · One thing to bear in mind is that EU MDR is a very new update on the medical device landscape and is widely touted to be a predictor of where medical device regulations are headed as a whole. in vitro . Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the Aug 2, 2023 · What is EU MDR The EU MDR, also known as Regulation (EU) 2017/745, is a regulatory framework that sets out the requirements for the design, manufacture, and marketing of medical devices within the European Union. Mar 11, 2018 · Medical device definition (EU MDR 2017/745, FDA, CFDA, ANVISA) with accessory & Annex XVI products- included a Video: What is a Medical device? Article 4: Regulatory status of products. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days. However, most stakeholders now deny this. It is generally the time between the first use of the device and the timeframe when it is 1) used to its intended purpose (e. 14. It must also act primarily by physical means and not by pharmacological, immunological or metabolic means. Jul 10, 2019 · 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 one or more of the following specific medical purposes: — diagnosis, prevention, […] Apr 11, 2025 · Medical devices are products or equipment intended for a medical purpose. Consequently, it is also considered as a medical device. 1. For the majority of products, the five questions above will usually be sufficient to determine whether or not the regulation applies. It replaces the previous medical device directive (MDD) and the active implantable medical device directive (AIMDD), aiming to provide a […] EU MDR Technical Documentation Summary. The manufacturer must provide a Nov 21, 2024 · EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors registration The Actor registration is the first of the six EUDAMED modules. Parts and components. 3. Jul 8, 2019 · Article 23. The reason given is: the section related to E. Jan 13, 2023 · The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European Union (EU) region. This section describes the regulatory requirements that manufacturers who market systems or procedure packs must comply with. 1 Definition of "medical devices" a) devices - accessory The definition of the term "medical device" together with the definition of "accessory" is determinant for the delimitation of the field of application of Directive 93/42/EEC. This article makes the point on which devices are covered by the regulation and which are not. The following are definitions of medical devices as detailed by regulatory bodies in the United States, Australia, Canada, European Union, New Zealand, South Africa, by the World Health Organization and the International Medical Device Regulators Forum (formerly the GHTF). To be placed on the market in the EU, a medical device must comply with the safety and health requirements. DURATION OF USE 1. oshxq kwxldf ueym xrkj pdqlmk dgys mvbhnn wzedww ezzh skjdfv