--- title: MDR Article 2 Definitions Explained: The 50 Terms Every Startup Needs to Know description: Article 2 of the EU MDR contains over 70 definitions that determine your regulatory path — here are the 50 most critical terms for MedTech startups, explained in plain language. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: canonical_url: https://zechmeister-solutions.com/en/blog/mdr-article-2-definitions source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # MDR Article 2 Definitions Explained: The 50 Terms Every Startup Needs to Know *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* Article 2 of the MDR contains the definitions that underpin the entire regulation. Every obligation, every classification rule, every conformity assessment procedure uses the terms defined here. Misunderstand a definition and your entire regulatory strategy can go sideways. There are over 70 definitions in Article 2 . Not all of them matter equally for a startup in its first year. Here are the 50 terms that directly affect your decisions, explained in plain language with the regulatory precision intact. ## The Definitions That Determine Whether You Are Regulated **"Medical device" — Article 2(1)** This is the definition that starts everything. A medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for one or more specific medical purposes, including: - Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease - Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability - Investigation, replacement, or modification of the anatomy or a physiological or pathological process or state - Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations The critical phrase is "intended by the manufacturer." Your marketing claims, your instructions for use, your promotional materials — these establish the intended purpose and therefore determine whether your product is a medical device. We cover this in depth in [What Is a Medical Device Under MDR? The Definition That Decides Your Regulatory Path](/blog/006-what-is-medical-device-under-mdr). **"Intended purpose" — Article 2(12)** The use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials or statements, and as specified by the manufacturer in the clinical evaluation. This definition makes your own communications the legal basis for classification. Choose your words carefully. **"Manufacturer" — Article 2(30)** The 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. This is broader than you might expect — you are a manufacturer even if you outsource all production, as long as the device is marketed under your name. See [What Is a Manufacturer Under MDR Article 2(30)? Legal Obligations for Startup Founders](/blog/020-manufacturer-mdr-article-2-30). **"Placing on the market" — Article 2(28)** The first making available of a device, other than an investigational device, on the Union market. "First making available" means the first time the device is supplied for distribution, consumption, or use on the Union market. This is a one-time event per individual device — you place a device on the market once. **"Making available on the market" — Article 2(27)** Any supply of a device, other than an investigational device, for distribution, consumption, or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. This is broader than "placing on the market" — it covers every subsequent transfer in the supply chain. **"Putting into service" — Article 2(29)** The stage at which a device has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose. For some devices, this is the same as placing on the market. For others (like devices that require installation), there is a gap between the two. ## The Definitions That Shape Your Classification **"Risk class"** Not explicitly defined in Article 2, but the MDR classifies devices into four risk classes: I, IIa, IIb, and III — from lowest to highest risk. Classification rules are in Annex VIII. **"Invasive device" — Article 2(6)** A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. Classification rules depend heavily on whether your device is invasive. **"Active device" — Article 2(4)** A device whose operation depends on a source of energy other than that generated by the human body for that purpose, or by gravity. Software is always considered an active device under the MDR . **"Implantable device" — Article 2(5)** A device intended to be totally or partially introduced into the human body, or to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Implantable devices face the strictest requirements under MDR. **"Software" (in context of medical devices)** While not defined separately in Article 2, the MDR includes software in the definition of "medical device" (Article 2(1)) and treats standalone software as a medical device when it meets the intended purpose criteria. Rule 11 in Annex VIII provides specific classification rules for software. ## The Definitions That Define Your Obligations as a Manufacturer **"Quality management system"** Not explicitly defined in Article 2, but Article 10(9) requires every manufacturer to establish, document, implement, maintain, continually update, and systematically evaluate a QMS. EN ISO 13485 is the harmonized standard that provides the framework. **"Technical documentation"** The set of documents described in Annexes II and III that demonstrates your device's conformity with the MDR. This is the primary deliverable of your regulatory work. **"Clinical evaluation" — Article 2(44)** A systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer. **"Clinical investigation" — Article 2(45)** A systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. This is the MDR term for what is commonly called a clinical study or clinical trial. **"Clinical evidence" — Article 2(51)** Clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits when used as intended. **"Post-market surveillance" — Article 2(60)** All activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions. **"Recall" — Article 2(64)** Any measure aimed at achieving the return of a device that has already been made available to the end user. Distinct from a "field safety corrective action" (Article 2(66)), which covers any corrective action taken to reduce risk of death or serious deterioration. ## The Definitions for Your Supply Chain **"Authorized representative" — Article 2(32)** Any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the manufacturer's obligations under the MDR. If you are an EU-based startup, you do not need an authorized representative. If your manufacturing entity is outside the EU, you do. See [Authorized Representatives Under MDR: When You Need One and How to Choose](/blog/021-authorized-representatives). **"Importer" — Article 2(33)** Any natural or legal person established within the Union that places a device from a third country on the Union market. **"Distributor" — Article 2(34)** Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service. **"Economic operator" — Article 2(35)** A manufacturer, an authorized representative, an importer, or a distributor. Each has specific obligations under Chapter II of the MDR. ## The Definitions for Conformity Assessment **"Conformity assessment" — Article 2(40)** The process demonstrating whether the requirements of the MDR relating to a device have been fulfilled. This is the overall process — from building your QMS to compiling your technical documentation to undergoing the Notified Body audit. **"Notified body" — Article 2(42)** A conformity assessment body designated in accordance with the MDR to carry out third-party conformity assessment activities. See [What Is a Notified Body and How Do They Audit Your Startup?](/blog/014-what-is-notified-body). **"CE marking of conformity" / "CE marking" — Article 2(43)** A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements of the MDR and other applicable Union harmonization legislation. The CE mark is not an approval — it is the manufacturer's declaration that the device conforms to the regulation. **"EU declaration of conformity"** The document in which the manufacturer declares that the device meets the requirements of the MDR. Structure defined in Annex IV. See [The EU Declaration of Conformity Under MDR: What to Include and How to Write It](/blog/033-eu-declaration-of-conformity). ## The Definitions for Safety and Performance **"Benefit-risk determination"** The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer. This is central to Annex I compliance. **"State of the art"** Not defined in Article 2 but referenced throughout the MDR (particularly in Annex I). It means the developed stage of current best technical capability and clinical practice in relation to the safety, performance, and design of devices. The state of the art is a moving target — what was acceptable five years ago may not be acceptable today. See [The State of the Art Principle in MDR: What It Means for Your Design Decisions](/blog/040-state-of-the-art). **"Performance"** The ability of a device to achieve its intended purpose as stated by the manufacturer. Performance claims must be supported by evidence. **"Serious incident" — Article 2(65)** Any incident that directly or indirectly led, might have led, or might lead to: death of a patient, user, or other person; temporary or permanent serious deterioration of a patient's, user's, or other person's state of health; a serious public health threat. Serious incidents must be reported to the competent authority within defined timelines (Article 87). **"Field safety corrective action" — Article 2(66)** A corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market. ## The Definitions for Labeling and Information **"Label" — Article 2(13)** The written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit, or on the packaging of multiple devices. **"Instructions for use" — Article 2(14)** The information provided by the manufacturer to inform the device user of a device's intended purpose and proper use and of any precautions to be taken. **"Unique Device Identification" (UDI) — Article 2(15)** A series of numeric or alphanumeric characters that is created through an internationally accepted device identification and coding standard. It allows unambiguous identification of a specific device on the market. ## Why These Definitions Matter for Your Strategy Definitions are not academic exercises. They are the foundation of every regulatory decision. When Tibor assesses a startup's regulatory strategy, the first thing he does is verify that they have correctly understood three definitions: "medical device," "intended purpose," and "manufacturer." If any of these is wrong, everything downstream — classification, conformity assessment, documentation — is built on a flawed foundation. The single most consequential definition is "intended purpose." A few words in your intended purpose statement can shift your device from Class I to Class IIa, from needing no Notified Body to requiring full third-party assessment, from a 12-month timeline to a 30-month timeline. See [Borderline Products Under MDR: How to Determine If Your Innovation Is a Medical Device](/blog/009-borderline-products-mdr) for how intended purpose shapes classification for products on the boundary. Get the definitions right first. Everything else follows. Next: [What Is a Medical Device Under MDR? The Definition That Decides Your Regulatory Path](/blog/006-what-is-medical-device-under-mdr). --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*