--- title: Off-Label Use Under MDR: Legal Implications for Manufacturers description: Off-label use is a clinician's call, not the manufacturer's. But the moment you promote, hint at, or ignore it, MDR liability crosses the line onto you. authors: Tibor Zechmeister, Felix Lenhard category: Device Classification & Conformity primary_keyword: off-label use MDR manufacturer liability canonical_url: https://zechmeister-solutions.com/en/blog/off-label-use-mdr-manufacturers source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # Off-Label Use Under MDR: Legal Implications for Manufacturers *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **Off-label use is when a clinician or patient uses a CE-marked device outside the manufacturer's intended purpose as defined in MDR Article 2(12). The MDR does not regulate the practice of medicine, so a clinician's off-label decision is generally lawful. What the MDR does regulate is the manufacturer. The moment a manufacturer promotes, encourages, or knowingly ignores off-label use, liability crosses from the clinician to the manufacturer. Through Article 7, Article 10, Article 83, and Article 87.** **By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.** --- ## TL;DR - Off-label use means using a CE-marked device outside the manufacturer's stated intended purpose under MDR Article 2(12). "Off-label" is not an MDR-defined term, but the concept is regulated indirectly through several articles. - The MDR regulates manufacturers, not the practice of medicine. A clinician's decision to use a device off-label is a matter of national medical law. - Manufacturers cross into direct liability when they promote, recommend, or market off-label uses. Article 7 prohibits suggesting uses other than those in the certified intended purpose. - Known, systematic off-label use is a post-market surveillance signal under Article 83 and Annex III. Manufacturers must assess it, document it in the PMS file, and decide whether to act. - Serious incidents arising from foreseeable misuse, including off-label use, are reportable under Article 87. MDCG 2023-3 Rev.2 confirms user error and misuse are within vigilance scope. - A silent manufacturer who sees nothing is protected; a manufacturer whose sales or marketing team nudges customers toward off-label use has taken ownership of the risk. --- ## Why this matters. The sales call that changes everything A founder calls with what sounds like a commercial win. A hospital bought five units last quarter, and the lead clinician just posted a case series describing a novel application. Using the device for a patient group and indication not in the IFU. Other clinicians are asking. The sales team wants to "lean into the momentum." That is the moment of decision. Until the manufacturer speaks, the case series is the clinician's professional judgment. Covered by national medical practice law, not MDR. The moment sales forwards the post with a positive comment, or marketing cites the case series on the website, the manufacturer has crossed a legal line. The off-label use has become part of the promoted intended purpose under Article 2(12). Either update the intended purpose formally through the conformity assessment process, or stay silent. There is no safe third path. ## The MDR does not use the term "off-label". But it regulates the concept "Off-label use" is not defined in Regulation (EU) 2017/745. You will not find the phrase in Article 2. The concept is borrowed from pharmaceutical regulation and applied informally in MedTech to describe any use of a CE-marked device outside the manufacturer's stated intended purpose. That stated intended purpose is defined in Article 2(12): > *"'intended purpose' means 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."*. Regulation (EU) 2017/745, Article 2, point (12). Anything a clinician does with the device outside this four-source statement is, colloquially, off-label. The MDR regulates the manufacturer's relationship to that use through several specific articles. Not by banning off-label practice, but by drawing a bright line around what the manufacturer can say, sell, and ignore. ## MDR Article 7. The promotion limit Article 7 is the anchor. It prohibits, in the labelling, the IFU, the making available, putting into service, and advertising of devices, the use of text, names, trade marks, pictures, and figurative or other signs that may mislead the user or the patient about the device's intended purpose, clinical benefit, safety, or performance. It also prohibits attributing functions the device does not have, creating a false impression regarding treatment or diagnosis, and suggesting uses other than those stated as forming part of the intended purpose for which the conformity assessment was carried out. Read that last prohibition carefully. Article 7 explicitly forbids suggesting uses not in the intended purpose covered by the conformity assessment. This is the MDR's direct answer to manufacturer promotion of off-label use. You can sell the device for what it is certified for. You cannot, in any communication channel, hint that it does something else. The channels are broad: labelling, IFU, making available, putting into service, and advertising. "Advertising" covers websites, social media posts, sales presentations, congress booths, webinars, sponsored scientific communications, and printed or digital collateral. If the manufacturer pays for it, sends it, or signs it, it is in scope. The same case series that a clinician may lawfully publish in a peer-reviewed journal cannot be reprinted on the manufacturer's website with a "learn more" CTA without becoming an Article 7 violation. ## Article 10 and Annex I. The risk management link Article 10 obliges manufacturers to establish a risk management system in accordance with Annex I and to ensure devices comply with the general safety and performance requirements. Annex I, Section 5 requires manufacturers to reduce risks related to use error by considering users' technical knowledge, experience, education, training, and use environment. The operative concept is "reasonably foreseeable misuse". A term that travels from EN ISO 14971:2019+A11:2021 and EN 62366-1:2015+A1:2020 into regulatory practice. It includes off-label uses the manufacturer could reasonably anticipate, whether or not they approve. Risk and usability files that ignore known off-label patterns are incomplete. ## Article 83 and Article 87. PMS and vigilance pick it up Article 83 requires manufacturers to establish a post-market surveillance system proportionate to the risk class that actively gathers and analyses data on quality, performance, and safety, and uses the conclusions to update the clinical evaluation, risk management file, technical documentation, and IFU. MDCG 2025-10 (December 2025) describes the PMS system in detail. Real-world use patterns. Including off-label use detected through complaints, published literature, congress reports, and sales channel intelligence. Are within PMS scope. Annex III of the MDR requires detected patterns to be assessed, documented, and fed into device decision-making. Silence stops being a defence here. A manufacturer who logs off-label use and takes no action has documented their own knowledge, and in enforcement that documentation becomes evidence. Article 87 requires manufacturers to report serious incidents involving devices on the Union market. MDCG 2023-3 Rev.2 (January 2025) confirms that incidents arising from user error and reasonably foreseeable misuse are within vigilance scope when they meet the serious-incident threshold. If a patient is seriously harmed because a clinician used the device off-label, and the off-label use was reasonably foreseeable, the resulting incident can be reportable. The manufacturer's lack of approval for the off-label use does not exempt them from the reporting duty. ## Test. Two case scenarios **Scenario one: the clinician publishes, the manufacturer stays silent.** A cardiologist uses a CE-marked device for a novel indication and publishes a case report. The manufacturer logs the publication, concludes the off-label use is not something to certify, and issues no statement. Sales is instructed not to reference it. The risk file is updated to include the novel use as foreseeable misuse, with controls assessed. Conclusion: the manufacturer behaved correctly. Clinician speech is protected, awareness is documented, promotion is avoided. Article 7 is not triggered. **Scenario two: the manufacturer encourages the use.** Same publication. Sales forwards it to prospects calling it "a breakthrough application." Marketing posts a LinkedIn summary tagging the product. The sales deck adds the application under "emerging uses." Conclusion: the manufacturer has crossed every line Article 7 draws. Under Article 2(12), the promotional statements are now a source of intended purpose, and the promoted use is not covered by the CE certificate. Article 7 is violated, the conformity assessment is out of date, and any resulting incident becomes a much larger problem. The technical facts are identical. The difference is entirely in what the manufacturer chose to say. ## Ship. The off-label monitoring and decision playbook A working off-label process for a resource-constrained startup has three parts, all inside the QMS. **Monitor.** The PMS plan lists explicit data sources for off-label detection: complaints, customer feedback, sales call reports, congress observations, literature searches, social media mentions, and scientific correspondence. Each source has a review cadence. Every signal is logged with date, source, description, and initial assessment. **Assess.** When a signal is logged, risk management evaluates whether it is a reasonably foreseeable misuse to add to the file under Annex I, Section 5. Clinical evaluates whether it carries benefit or risk the current clinical evaluation does not cover. Vigilance evaluates whether it has caused or could cause reportable incidents under Article 87. **Decide.** The output is a documented decision signed by the person responsible for regulatory compliance under Article 15. Three buckets. **Option A:** document and monitor, because the off-label use is rare, low-risk, and not promoted. **Option B:** strengthen risk controls. IFU warning, field safety information, improved user training. Because the use is foreseeable but should not become part of the intended purpose. **Option C:** formally expand the intended purpose, which triggers change assessment, possible significant change notification to the Notified Body, updated clinical evaluation, and updated conformity assessment. There is no Option D. "Let sales talk about it informally" is not on the menu. That is implicit Option C without any of the regulatory work, and it is enforcement exposure. ## Reality Check. Where do you stand? 1. Can you point to the place in your PMS plan where off-label use is listed as a data source, with a defined review cadence? 2. If a prospect asks your sales lead whether the device can be used outside the IFU, do you know exactly what they are trained to say. And is it written down? 3. Has your marketing team been briefed that Article 7 covers websites, LinkedIn, sales decks, congress booths, and webinars as "advertising"? 4. Do your risk and usability files include a reasonably-foreseeable-misuse analysis that names specific off-label scenarios? 5. When a serious incident arrives, does your vigilance process explicitly ask whether off-label use contributed, or default to "user error, out of scope"? 6. If a regulator asked today for the log of off-label signals detected in the last twelve months and the decisions on each, could you produce it in a working day? 7. Have you ever formally chosen Option B or Option C in response to detected off-label use, and documented the reasoning? ## Frequently Asked Questions **Is off-label use of medical devices legal in the EU?** For clinicians, generally yes. The MDR does not regulate the practice of medicine, and using a CE-marked device outside the intended purpose is governed by national medical and professional law. For manufacturers, promoting or suggesting off-label use is not legal: Article 7 explicitly prohibits suggesting uses other than those stated as forming part of the intended purpose for which the conformity assessment was carried out. **Can a manufacturer be held liable for off-label use of its device?** Yes, in several situations. If the manufacturer promoted the use, they have violated Article 7 and the use has become part of their stated intended purpose under Article 2(12). If the use was reasonably foreseeable and the manufacturer failed to address it in the risk, usability, or PMS systems, Article 10 and Annex I obligations apply. If a serious incident arose, vigilance obligations under Article 87 may apply. **Does a clinician's off-label use change the manufacturer's intended purpose?** Not by itself. Intended purpose under Article 2(12) is defined by the manufacturer's own written statements in four named sources. A clinician's independent decision does not change any of them. What changes the intended purpose is the manufacturer's response. If they endorse or promote the use, their own promotional statements expand the intended purpose. **Is off-label use reportable as a vigilance incident?** Off-label use in itself is not reportable. A serious incident involving a device is reportable under Article 87 when the criteria are met, regardless of whether the use was on-label or off-label. MDCG 2023-3 Rev.2 confirms incidents arising from user error and reasonably foreseeable misuse are within vigilance scope. **What should a manufacturer do when they detect systematic off-label use?** Log it in PMS under Article 83 and Annex III, assess it in the risk file under Annex I Section 5, evaluate clinical implications, and document a decision: continue monitoring, strengthen controls (warnings, training, field safety information), or formally expand the intended purpose. What a manufacturer must not do is allow informal promotion by sales or marketing. That triggers Article 7 without any of the regulatory work a purpose expansion requires. ## Related reading - [Intended Purpose vs. Intended Use: The Critical Distinction Under MDR Article 2(12)](/blog/intended-purpose-vs-intended-use-mdr) – the foundational definition this post builds on. - [Promotional Material Under MDR Article 7: What You Can and Cannot Say](/blog/promotional-material-mdr-article-7) – the companion post on advertising. - [Misleading Claims Under MDR: How Article 7 Traps Well-Intentioned Manufacturers](/blog/misleading-claims-mdr) – the enforcement angle on Article 7. ## Sources 1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 2(12) (intended purpose), Article 7 (claims), Article 10 (general obligations of manufacturers), Article 15 (person responsible for regulatory compliance), Article 83 (post-market surveillance system), Article 87 (reporting of serious incidents), Annex I (general safety and performance requirements, in particular Section 5 on use error), Annex III (technical documentation on PMS). Official Journal L 117, 5.5.2017. 2. MDCG 2023-3 Rev.2, Questions and Answers on vigilance terms and concepts as outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746, Revision 2, January 2025. 3. MDCG 2025-10, Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, December 2025. 4. EN ISO 14971:2019 + A11:2021, Medical devices. Application of risk management to medical devices. 5. EN 62366-1:2015 + A1:2020, Medical devices. Part 1: Application of usability engineering to medical devices. --- *This post is part of the Device Classification & Conformity Assessment series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Off-label use is one of the narrowest lines in MDR compliance. Walk it deliberately, not accidentally.* --- *This post is part of the [Device Classification & Conformity](https://zechmeister-solutions.com/en/blog/category/classification) 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).*