[{"data":1,"prerenderedAt":334},["ShallowReactive",2],{"update-en-20260723-mdr-class-iia-and-iib":3,"related-posts-20260716-mdr-iib-en":190},{"id":4,"title":5,"body":6,"description":172,"extension":173,"meta":174,"navigation":183,"ogImage":184,"path":185,"robots":184,"seo":186,"sitemap":187,"stem":188,"__hash__":189},"updates/en/updates/20260723-mdr-class-iia-and-iib.md","MDR Classes IIa and IIb are not rungs on a ladder",{"type":7,"value":8,"toc":163},"minimark",[9,26,30,33,36,39,44,47,50,53,56,60,63,66,93,96,99,103,106,109,112,115,119,122,125,128,131,134,138],[10,11,13],"key-takeaways",{"title":12},"In short",[14,15,16,20,23],"ul",{},[17,18,19],"li",{},"MDR classification is not a measure of how compliant or mature a company is. Devices in every class must meet the requirements that apply to them.",[17,21,22],{},"Before discussing Class I, IIa, IIb or III, you first have to determine whether the software qualifies as a medical device at all.",[17,24,25],{},"The classification follows from the software's intended purpose, the clinical situation and the potential consequences of incorrect information.",[27,28,29],"p",{},"More and more healthcare software companies are announcing certification as a Class IIa medical device. That is a real achievement and should be taken seriously.",[27,31,32],{},"At the same time, MDR classes are often discussed as if they were successive levels on a compliance ladder: Class IIa is good, Class IIb is better and Class III is best.",[27,34,35],{},"That is not how the Medical Device Regulation works.",[27,37,38],{},"A Class IIb device is not necessarily more compliant, more advanced or more effective than a Class IIa device. Both must comply fully with the requirements that apply to their classification. The difference is primarily about the device's intended purpose and the risks associated with the clinical decisions it informs.",[40,41,43],"h2",{"id":42},"first-is-the-software-a-medical-device","First: is the software a medical device?",[27,45,46],{},"Before assigning a class, there is a more fundamental question: does the software qualify as a medical device at all?",[27,48,49],{},"Not every piece of software used in healthcare falls under the MDR. Software used only for administration, communication, storage or simple search will often not qualify as medical device software. The same may apply to general wellness products without an intended medical purpose.",[27,51,52],{},"This is an important distinction. Such software is not automatically Class I; it may sit outside the medical-device framework altogether.",[27,54,55],{},"Software becomes medical device software when its manufacturer gives it an intended medical purpose that falls within the MDR definition. Once that has been established, the relevant classification rules determine whether it belongs in Class I, IIa, IIb or III.",[40,57,59],{"id":58},"classification-is-not-a-compliance-score","Classification is not a compliance score",[27,61,62],{},"For medical device software, Rule 11 of the MDR is often central. It classifies software according to the significance of the information it provides, the clinical context in which it is used and the potential consequences of the decisions it informs.",[27,64,65],{},"In simplified terms:",[14,67,68,75,81,87],{},[17,69,70,74],{},[71,72,73],"strong",{},"Class I."," The remaining category for medical device software that is not covered by the higher-risk parts of Rule 11 or another applicable rule. European guidance gives examples such as software that helps people with communication disorders convert selected symbols into spoken language. Class I software can generally be self-declared by the manufacturer.",[17,76,77,80],{},[71,78,79],{},"Class IIa."," The starting classification for software that provides information used to make diagnostic or therapeutic decisions, unless the possible impact of those decisions meets the threshold for IIb or III. It also covers certain software used to monitor physiological processes.",[17,82,83,86],{},[71,84,85],{},"Class IIb."," Software is classified as IIb when the decisions it informs could lead to a serious deterioration in a person's health or to a surgical intervention. It can also include software continuously monitoring vital physiological parameters when changes could place the patient in immediate danger.",[17,88,89,92],{},[71,90,91],{},"Class III."," Software is classified as III when the decisions it informs could lead to death or an irreversible deterioration in a person's health.",[27,94,95],{},"These summaries are useful, but they are not enough to classify a real product. European guidance explicitly says that examples are illustrative and that classification can change when the intended purpose, patient population or context of use changes.",[27,97,98],{},"The same apparent functionality can therefore fall into a different class when used for a different population, condition or clinical decision.",[40,100,102],{"id":101},"the-real-difference-between-iia-and-iib","The real difference between IIa and IIb",[27,104,105],{},"Class IIa and Class IIb are not simply two distances along the same product roadmap. They reflect different risk profiles.",[27,107,108],{},"Class IIa is the default under Rule 11 for software that provides information used in diagnosis or therapy. Class IIb applies when the potential consequences of the decisions informed by that software cross a specific threshold: serious deterioration of health or surgical intervention.",[27,110,111],{},"That does not mean Class IIa software is limited to administrative or trivial work. The official European guidance includes meaningful clinical functions among its IIa examples. Nor does involving a healthcare professional automatically make software Class IIa. Human review is important, but classification still depends on the intended purpose, clinical context and potential impact of the decision.",[27,113,114],{},"Similarly, a Class IIb conformity assessment does not give a manufacturer general permission to make any clinical claim. A device is assessed and CE-marked for a specifically defined intended purpose. New functionality or claims may change its risk profile and require a new assessment.",[40,116,118],{"id":117},"why-ask-aletta-is-pursuing-class-iib","Why Ask Aletta is pursuing Class IIb",[27,120,121],{},"Our ambition is to develop Ask Aletta from a reactive clinical knowledge platform into a proactive assistant embedded in the clinical workflow.",[27,123,124],{},"We want it to understand the context of the patient, help healthcare professionals prepare consultations and provide information that supports medical decisions at the moment it matters. Some of those decisions may concern serious conditions where incorrect information could contribute to a serious deterioration in a patient's health or to a surgical intervention.",[27,126,127],{},"It is that intended purpose and associated risk profile—not a desire to obtain a higher number—that lead us to the Class IIb pathway.",[27,129,130],{},"We could define a narrower intended purpose and build a more limited product. But that would not be the Ask Aletta we are working towards. At the same time, pursuing Class IIb does not mean we can make unlimited claims. It means we must define precisely what the product is intended to do and produce the technical, clinical and quality evidence required to support that purpose.",[27,132,133],{},"The classification follows the product, not the other way around.",[40,135,137],{"id":136},"sources","Sources",[14,139,140,149,156],{},[17,141,142],{},[143,144,148],"a",{"href":145,"rel":146},"https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng",[147],"nofollow","Regulation (EU) 2017/745 on medical devices, including Rule 11",[17,150,151],{},[143,152,155],{"href":153,"rel":154},"https://health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en",[147],"MDCG 2019-11 rev.1: Qualification and classification of software",[17,157,158],{},[143,159,162],{"href":160,"rel":161},"https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf",[147],"MDCG 2021-24 rev.1: Guidance on classification of medical devices",{"title":164,"searchDepth":165,"depth":165,"links":166},"",2,[167,168,169,170,171],{"id":42,"depth":165,"text":43},{"id":58,"depth":165,"text":59},{"id":101,"depth":165,"text":102},{"id":117,"depth":165,"text":118},{"id":136,"depth":165,"text":137},"MDR classification is not a compliance score. It follows from a medical device's intended purpose, clinical context and potential impact on patients.","md",{"date":175,"category":176,"author":177,"readingTime":178,"translations":179,"relatedPosts":181},"2026-07-23","blog","tijs.stehmann",5,{"nl":180},"20260723-mdr-klasse-iia-en-iib",[182],"20260716-mdr-iib",true,null,"/en/updates/20260723-mdr-class-iia-and-iib",{"title":5,"description":172},{"loc":185},"en/updates/20260723-mdr-class-iia-and-iib","9BmR-Oqhfvp6VAStwYJS4HKUG7Qgpw_UKmvvUL5ucnE",[191],{"id":192,"title":193,"body":194,"description":322,"extension":173,"meta":323,"navigation":183,"ogImage":184,"path":329,"robots":184,"seo":330,"sitemap":331,"stem":332,"__hash__":333},"updates/en/updates/20260716-mdr-iib.md","We're pursuing MDR Class IIb certification",{"type":7,"value":195,"toc":313},[196,209,212,216,219,222,225,229,232,235,239,242,245,249,252,255,259,267,270,273,276,280,283,286,300,303,307,310],[10,197,198],{"title":12},[14,199,200,203,206],{},[17,201,202],{},"Ask Aletta is evolving from a reactive knowledge platform into a proactive AI assistant embedded in the clinical workflow.",[17,204,205],{},"The intended purpose of that product puts it on the path towards certification as Class IIb medical device software under the MDR.",[17,207,208],{},"Having already achieved ISO 27001 certification, we are now working towards completing the MDR certification process within the next few months.",[27,210,211],{},"We haven't written publicly about this before, so consider this an introduction and a look at where Ask Aletta is headed.",[40,213,215],{"id":214},"mediocre-certified-beats-great-uncertified","Mediocre certified beats great uncertified",[27,217,218],{},"Here is an uncomfortable truth about healthcare software: a mediocre certified product will beat a great uncertified one almost every time.",[27,220,221],{},"Certification does not automatically make a product good, but it does show that the manufacturer has met defined requirements for safety, quality and risk management. In healthcare, where patient safety is on the line, those assurances matter. For regulated clinical uses, certification is therefore not simply a preference but a condition of entry. Hospitals, GP practices and procurement departments cannot adopt an uncertified product for an intended use that requires compliance with the Medical Device Regulation.",[27,223,224],{},"From the beginning, we set out to build a product that is both great and certified.",[40,226,228],{"id":227},"our-first-foundation-iso-27001","Our first foundation: ISO 27001",[27,230,231],{},"We took an important first step by becoming ISO 27001 certified. Information security is fundamental to software that healthcare professionals must be able to rely on, particularly when that software will eventually work with clinical context and patient information.",[27,233,234],{},"Rather than adding security processes later, we wanted this foundation in place early, before beginning the next stage of our regulatory journey.",[40,236,238],{"id":237},"where-we-are-today-reactive","Where we are today: reactive",[27,240,241],{},"Today, Ask Aletta is a reactive AI knowledge platform: healthcare professionals ask a question, and Ask Aletta helps them find an answer.",[27,243,244],{},"They use the platform to search clinical guidelines, summarise documents, draft patient communication and support referral letters. All of this happens in the browser and begins with a request from the user. It is already very useful, as our users tell us every day, but it is not yet the product we ultimately set out to build.",[40,246,248],{"id":247},"where-were-going-proactive","Where we're going: proactive",[27,250,251],{},"The future of Ask Aletta is a proactive AI assistant that works inside a healthcare professional's HIS, EHR or patient communication platform. It will be embedded in the clinical workflow, with an understanding of the context in which the healthcare professional is working and the history of the patient in front of them.",[27,253,254],{},"With that context, Ask Aletta will help healthcare professionals prepare for consultations, support clinical decisions, draft documents and surface relevant information before they have thought to ask for it. This is how we want Ask Aletta to develop from a reactive knowledge platform into a proactive assistant within the care process.",[40,256,258],{"id":257},"why-that-requires-mdr-certification","Why that requires MDR certification",[27,260,261,262,266],{},"Whether software qualifies as a medical device depends on its intended purpose. The product we intend to build will provide information used to support diagnostic and therapeutic decisions for individual patients, bringing it within the scope of the ",[143,263,265],{"href":145,"rel":264},[147],"EU Medical Device Regulation",".",[27,268,269],{},"Under Rule 11 of the MDR, software that informs diagnostic or therapeutic decisions may be classified as Class IIb when those decisions could result in a serious deterioration in a person's health or a surgical intervention. Based on the intended purpose and risk profile of the product we are building, Class IIb is the pathway we are pursuing.",[27,271,272],{},"This requires us to demonstrate far more than technical performance. The process includes systematic risk management, clinical evaluation, quality management, verification, validation and continuous monitoring after the product enters the market.",[27,274,275],{},"For the product we envision, there is no responsible shortcut around that work. If we want Ask Aletta to operate inside the clinical workflow, at the moment important decisions are made, we must meet the standards that decisions of that weight demand. That is why we are pursuing MDR Class IIb certification and why we are doing the work now.",[40,277,279],{"id":278},"why-we-think-healthcare-needs-this","Why we think healthcare needs this",[27,281,282],{},"This is more than a product decision; it is a bet on what healthcare needs. Healthcare costs are rising as the population ages, while fewer healthcare professionals are being asked to care for more patients.",[27,284,285],{},"We believe AI can make a meaningful contribution in two areas:",[14,287,288,294],{},[17,289,290,293],{},[71,291,292],{},"Quality of care."," Making it easier for care to follow the guidelines and evidence that healthcare professionals have collectively agreed represent best practice.",[17,295,296,299],{},[71,297,298],{},"Efficiency."," Supporting healthcare professionals directly inside their existing workflow, rather than asking them to interrupt that workflow to use another tool.",[27,301,302],{},"AI will not solve the pressures facing healthcare on its own. Applied responsibly, in the right place and with the right safeguards, however, it can help healthcare professionals spend more of their time on the work that only they can do.",[40,304,306],{"id":305},"closer-than-you-might-think","Closer than you might think",[27,308,309],{},"This is not a distant roadmap item. We are already well into the process and aim to complete the Class IIb certification process within the next few months.",[27,311,312],{},"There is still important work ahead, and certification is never something to take for granted, but the direction is clear. We will share more about the process as we progress. For now, we wanted you to know what we are building towards and why.",{"title":164,"searchDepth":165,"depth":165,"links":314},[315,316,317,318,319,320,321],{"id":214,"depth":165,"text":215},{"id":227,"depth":165,"text":228},{"id":237,"depth":165,"text":238},{"id":247,"depth":165,"text":248},{"id":257,"depth":165,"text":258},{"id":278,"depth":165,"text":279},{"id":305,"depth":165,"text":306},"Ask Aletta is evolving from a reactive clinical knowledge platform into a proactive AI assistant embedded in the clinical workflow. Here is why that requires MDR Class IIb certification.",{"date":324,"category":325,"author":177,"readingTime":326,"translations":327},"2026-07-16","news",4,{"nl":328},"we-gaan-voor-mdr-klasse-iib","/en/updates/20260716-mdr-iib",{"title":193,"description":322},{"loc":329},"en/updates/20260716-mdr-iib","pYL4DheM_uSf2I3M4UEEm_qGtsKgKXGPftSgZdvbJMc",1786722069869]