Table of contents<\/h2>\n\n- 1. Qualification and classification of software medical devices<\/a>\n
\n- 1.1 Formulation of the intended use for (software) medical devices<\/a><\/li>\n
- 1.2 Qualification: Is your software a medical device?<\/a><\/li>\n
- 1.3 Classification of software medical devices: MDR guidance<\/a><\/li>\n
- 1.4 MDR risk class I vs. IIa: Differences for software medical devices<\/a><\/li>\n
- 1.5 Class I software according to MDR \u2013 Is this still possible? (January 2025)<\/a><\/li>\n
- 1.6 IVDR software: Qualification and classification<\/a><\/li>\n<\/ul>\n<\/li>\n
- 2. Guidelines on aspects of SaMD development and approval<\/a>\n
\n- 2.1 Approval and certification of software medical devices (MDR)<\/a><\/li>\n
- 2.2 IEC 62304: Software life cycle processes for medical devices<\/a><\/li>\n
- 2.3 ISO 13485 \u2013 Guidelines on requirements and content<\/a><\/li>\n
- 2.4 Software as a medical device: 11 certification tips for manufacturers<\/a><\/li>\n
- 2.5 Validation of medical device software in accordance with MDR<\/a><\/li>\n
- 2.6 MDR guidance: Clinical evaluation of software medical devices<\/a><\/li>\n
- 2.7 Artificial intelligence (AI) in medical devices \u2013 MDR guidance (2026)<\/a><\/li>\n
- 2.8 Approval of software medical devices without quality management and regulation?<\/a><\/li>\n<\/ul>\n<\/li>\n
- 3. Reimbursement and remuneration for software medical devices<\/a>\n
\n- 3.1 Digital health applications \u2013 our detailed guidelines<\/a><\/li>\n
- 3.2 Selective contracts with health insurance companies: The alternative to DiGA<\/a><\/li>\n
- 3.3 Certification of digital courses in accordance with ZPP \u2013 Central Office for Prevention<\/a><\/li>\n
- 3.4 DiPA: digital applications for nursing care<\/a><\/li>\n
- 3.5 Reimbursement for software included in the GKV list of medical aids (HMV)<\/a><\/li>\n
- 3.6 Innovation funds and other subsidies for health software<\/a><\/li>\n
- 3.7 Cost reimbursement for software in hospitals<\/a><\/li>\n<\/ul>\n<\/li>\n
- 4. Further current information on the development of medical device software and DiGA<\/a><\/li>\n<\/ul>\n
1. Qualification and classification of software medical devices<\/h2>\n
![\"Intended](\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Blogartikel-Grafiken-600-\u00d7-400-px-1875-x-1250-px-980-x-870-px-980-x-1006-px-2.png\")
<\/a><\/p>\nIntended purpose and classification of medical devices<\/p>\n
1.1 Formulating the intended purpose for (software) medical devices<\/h3>\n
At the beginning of every medical device development, the intended purpose should be formulated, which also serves as the basis for assigning the risk class according to MDR:<\/p>\n
\u2192 Link to article<\/a><\/p>\n1.2 Qualification: Is your software a medical device?<\/h3>\n
Once you have formulated the intended purpose, the question arises: \u201cIs your software even a medical device according to the MDR?\u201d If this is not the case, you do not need to concern yourself further with the MDR.<\/p>\n
Read this article to find out for your product.<\/p>\n
\u2192 Link to article<\/a><\/p>\n1.3 Classification of software medical devices: MDR guidance<\/h3>\n
The risk class of a medical device makes a huge difference to the effort and costs you will need to invest in obtaining approval. You should therefore clarify this before starting product development.<\/p>\n
\u2192 Link to article<\/a><\/p>\n1.4 MDR risk class I vs. IIa: Differences for software medical devices<\/h3>\n
There are enormous differences in costs and timelines for product development, especially between risk class I and risk class IIa. What are the differences for you in practice?<\/p>\n
\u2192 Link to article<\/a><\/p>\n1.5 Class I software according to MDR \u2013 Is that still possible? (January 2025)<\/h3>\n
We discuss which software medical devices may still fall under Class I as of 2025.<\/p>\n
\u2192 Link to article<\/a><\/p>\n1.6 IVDR software: Qualification and classification<\/h3>\n
If your software is intended for obtaining information through in vitro examinations, it may fall under the IVDR (In Vitro Diagnostics Regulation). Our guide explains how you can qualify and classify your software under the IVDR to ensure that it meets the relevant regulatory requirements.<\/p>\n
\u2192 Link to article<\/a><\/p>\n2. Guides on aspects of SaMD development and approval<\/h2>\n
![\"Path](\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Blogartikel-Grafiken-ZUoeassung-Medical-Sofware-1485-x-1745-px-2.png\")
<\/a><\/p>\nTimeline: The path to medical device approval<\/p>\n
2.1 Approval & certification of software medical devices (MDR)<\/h3>\n
Here we provide a holistic overview of all aspects of the approval of Software as a Medical Device (SaMD).<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.2 IEC 62304: Software life cycle processes for medical devices<\/h3>\n
IEC 62304 is arguably the most important standard for the development of software medical devices. But how exactly can it be put into practice, and can it be combined with agile development?<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.3 ISO 13485 \u2013 Guidance on requirements and content<\/h3>\n
The quality management system of a SaMD manufacturer should be in line with ISO 13485 within the framework of the MDR. This is the most important standard for the conformity of quality management systems for medical devices.<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.4 Software as a medical device: 11 certification tips for manufacturers<\/h3>\n
We have been developing software medical devices on a contract basis for other companies for over 10 years. We have written down our most important learnings and tips for future manufacturers here.<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.5 Validation of medical device software according to MDR<\/h3>\n
Before a software medical device can be placed on the market, it must be formally validated. You can find out exactly what this means here.<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.6 MDR Guide: Clinical evaluation of software medical devices<\/h3>\n
Clinical evaluation is at the heart of software medical device validation and poses major challenges for some manufacturers. We discuss what you need to do in this context. We also explain when you need to conduct a clinical study\/trial and when a literature review is sufficient.<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.7 Artificial intelligence (AI) in medical devices \u2013 MDR guidance (2026)<\/h3>\n
MDR medical devices may, of course, also contain artificial intelligence (AI). However, the approval of such products brings with it a number of additional challenges. Here, we discuss what you should consider when developing AI medical devices.<\/p>\n
\u2192 Link to article<\/a><\/p>\n2.8 Approving software medical devices without quality management & regulations?<\/h3>\n
DiGA and the Medical Device Regulation (MDR) present manufacturers with a host of challenges \u2013 from setting up a quality management system (QMS) to creating technical documentation. No wonder many companies are wondering whether they can outsource this complexity.<\/p>\n
The good news is: yes, they can! By transferring the role of legal manufacturer to an external provider, the regulatory requirements can be completely outsourced to a third party.<\/p>\n
\u2192 Link to article<\/a><\/p>\n3. Reimbursement & compensation for software medical devices<\/h2>\n
![\"Methods](\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2025\/08\/Wege-der-Erstattung-Verguetung-von-Software-Medizinprodukten-1.png\")
<\/a><\/p>\nApproval as a medical device under the MDR enables you to market your product. However, this does not necessarily mean that you will earn money with it.<\/p>\n
In the German healthcare system in particular, it is often advisable to find a way to have your product reimbursed by health insurance companies. Depending on the type of software product, there are a range of reimbursement options available.<\/p>\n
The following guides provide an overview of important ways for software products to be reimbursed.<\/p>\n
3.1 Digital health applications \u2013 our detailed guides<\/h3>\n
Approval as a DiGA is probably the most popular way for patient-oriented applications or DTx to be reimbursed. However, approval is anything but easy and involves enormous regulatory hurdles. We have written specialist articles on many aspects of approval to provide manufacturers with additional information.<\/p>\n
\u2192 Link to all insights on DiGA development and approval in 2025<\/a><\/p>\n3.2 Selective contracts with health insurance companies: The alternative to DiGA<\/h3>\n
Selective contracts with health insurance companies are suitable for a wide range of SaMD and are a popular route to reimbursement.<\/p>\n
\u2192 Link to article<\/a><\/p>\n3.3 Certification of digital courses according to ZPP \u2013 Central Testing Center for Prevention<\/h3>\n
Manufacturers of products that focus on disease prevention should look into the Central Testing Center for Prevention. This represents a possible way to (partially) reimburse the costs of such applications.<\/p>\n
\u2192 Link to article<\/a><\/p>\n3.4 DiPA: digital applications for nursing care<\/h3>\n
The counterpart to DiGA in nursing care is DiPA. Find out how you can potentially get DiPA reimbursed here.<\/p>\n
\u2192 <\/b>Link to article<\/a><\/p>\n3.5 Reimbursement of software in the GKV medical aids directory (HMV)<\/h3>\n
Software products that qualify as medical aids and, for example, compensate for a malfunction of the body, can potentially be included in the medical aids directory. This represents another way to obtain reimbursement from health insurance companies.<\/p>\n
\u2192 <\/b>Link to article<\/a><\/p>\n3.6 Innovation fund and other subsidies for health software<\/h3>\n
There are various public funding programs for manufacturers of digital health solutions, depending on the project focus, maturity, and target market. One of the most important and practical sources of funding in the German healthcare system is undoubtedly the G-BA Innovation Fund<\/b>, which specifically supports new forms of care and offers attractive opportunities for software projects related to healthcare.<\/p>\n
\u2192<\/b> Link to article<\/a><\/p>\nIn addition to the Innovation Fund, there are other national and European funding instruments that can reduce development, study, or implementation costs and strategically secure market entry. Our white paper \u201cFinancing and Funding Digital Health Products<\/b>\u201d provides a structured overview of relevant funding programs, typical funding logic, and strategic classification.<\/p>\n
\u2192<\/b> Link to article<\/a><\/p>\n3.7 NUB as cost reimbursement for software products in hospitals<\/h3>\n
Could the NUB procedure (\u201cNew Examination and Treatment Methods\u201d) be a way to reimburse software innovations in hospitals? We analyzed over 2,400 NUB applications \u2013 with exciting results on the opportunities and limitations of cost reimbursement for digital solutions in hospitals.<\/p>\n
\u2192 Link to article<\/a><\/p>\n4. Further current information on the development of medical device software and DiGA<\/h2>\n
We have invested a lot of work and time in creating these guidelines and articles. We hope that they will provide you, as a manufacturer, with support in meeting your challenges.<\/p>\n
As an additional service, we recommend our newsletter, in which we send out detailed monthly reports on current topics in the field of medical device software and DiGA development.<\/p>\n
You can subscribe to the newsletter here: to the newsletter<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"The development of software medical devices is complex, and unfortunately, high-quality information on the subject is limited on the internet. We have been developing software medical devices for customers on a contract basis for over 10 years. During this time, we have implemented a wide range of app and software products (over 35 in total) […]<\/p>\n","protected":false},"author":22,"featured_media":24709,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"off","_et_pb_old_content":"In den letzten zehn Jahren haben wir eine Menge \u00fcber die Entwicklung von Software-Medizinprodukten gelernt. Dieses Know-how geben wir gerne in unseren Fachartikeln an (angehende) Entwickler von Software as a Medical Device (SaMD) weiter, damit nicht jeder dieselben Lektionen selbst machen muss.\r\n\r\nWir entwickeln Software-Medizinprodukte f\u00fcr Start-ups, Pharmaunternehmen und andere Firmen und begleiten daher den gesamten Entwicklungszyklus dieser Produkte \u2013 von der ersten Idee bis zur dauerhaften Zulassung und dar\u00fcber hinaus.\r\n\r\nIn diesem Beitrag m\u00f6chten wir Ihnen einen \u00dcberblick \u00fcber die Themen geben, zu denen wir bisher geschrieben haben.\r\n\r\nTipp: Wenn Sie neu in der Materie sind, macht es Sinn, dass Sie sich ganz einfach chronologisch von oben nach unten durch die Inhalte arbeiten.\u00a0<\/em>\r\nQualifizierung und Klassifizierung von Software-Medizinprodukten<\/h2>\r\n\r\n
Zweckbestimmung und Qualifikation von Medizinprodukten<\/p>\r\n\r\n
Formulierung der Zweckbestimmung f\u00fcr (Software-)Medizinprodukte<\/h3>\r\nZu Beginn jeder Medizinprodukt-Entwicklung sollte die Zweckbestimmung formuliert werden, welche auch als Basis f\u00fcr die Zuordnung zur Risikoklasse nach MDR dient:\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nQualifizierung: Ist Ihre Software ein Medizinprodukt?<\/h3>\r\nNachdem Sie die Zweckbestimmung formuliert haben, stellt sich die Frage \u201eIst Ihre Software \u00fcberhaupt ein Medizinprodukt nach MDR?\u201c. Wenn dies nicht der Fall ist, m\u00fcssen Sie sich auch nicht weiter mit der MDR auseinandersetzen.\r\n\r\nLesen Sie diesen Artikel, um dies f\u00fcr Ihr Produkt herauszufinden.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nKlassifizierung von Software-Medizinprodukten: MDR-Leitfaden<\/h3>\r\nDie Risikoklasse eines Medizinprodukts macht einen gewaltigen Unterschied f\u00fcr den notwendigen Aufwand und die Kosten, die Sie f\u00fcr die Zulassung investieren m\u00fcssen. Sie sollten dies also vor Beginn der Produktentwicklung abkl\u00e4ren.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nMDR Risikoklasse I vs. IIa: Unterschiede f\u00fcr Software-Medizinprodukte<\/h3>\r\nGerade zwischen Risikoklasse I und Risikoklasse IIa existieren enorme Unterschiede f\u00fcr Kosten und Zeitplan im Rahmen der Produktentwicklung. Was sind die Unterschiede f\u00fcr Sie in der Praxis?\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nKlasse I Software nach MDR \u2013 Geht das noch? (Januar 2025)<\/h3>\r\nWir gehen darauf ein, welche Software-Medizinprodukte Stand 2025 noch in Klasse I fallen k\u00f6nnen.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nLeitf\u00e4den zu Aspekten der Entwicklung und Zulassung von SaMD<\/h2>\r\n\r\n
Timeline: Der Weg zur Medizinproduktzulassung<\/p>\r\n\r\n
Zulassung & Zertifizierung von Software-Medizinprodukten (MDR)<\/h3>\r\nHier gehen wir einen holistischen \u00dcberblick \u00fcber alle Aspekte der Zulassung von Software as a Medical Device (SaMD) ein.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nIEC 62304: Software-Lebenszyklus-Prozesse von Medizinprodukten<\/h3>\r\nDie IEC 62304 ist die wohl zentralste Norm zur Entwicklung von Software-Medizinprodukten. Doch wie genau l\u00e4sst sich diese in die Praxis umsetzen und l\u00e4sst sich dies mit agiler Entwicklung vereinen?\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nISO 13485 \u2013 Leitfaden zu Anforderungen und Inhalten<\/h3>\r\nDas Qualit\u00e4tsmanagementsystem eines SaMD-Herstellers sollte mit der ISO 13485 im Rahmen der MDR im Einklang stehen. Dies stellt die wichtigste Norm f\u00fcr die Konformit\u00e4t von Qualit\u00e4tsmanagementsystemen f\u00fcr Medizinprodukte dar.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n\r\n[sc name=\"form_in_blog_middle\"]\r\nSoftware als Medizinprodukt: 11 Zertifizierungs-Tipps f\u00fcr Hersteller<\/h3>\r\nSeit \u00fcber 10 Jahren entwickeln wir Software-Medizinprodukte auf Auftragsbasis f\u00fcr andere Unternehmen. Wir haben hier unsere wichtigsten Learnings und Tipps f\u00fcr zuk\u00fcnftige Hersteller aufgeschrieben.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nValidierung von Medizinprodukt-Software nach MDR<\/h3>\r\nBevor ein Software-Medizinprodukt auf den Markt gehen kann, muss es formal validiert werden. Was das genau bedeutet, erfahren Sie hier.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nMDR-Guide: Klinische Bewertung von Software-Medizinprodukten<\/h3>\r\nDie klinische Bewertung ist das Kernst\u00fcck der Validierung von Software-Medizinprodukt und stellt manch einen Hersteller vor gro\u00dfe Herausforderungen. Wir gehen darauf ein, was Sie in diesem Rahmen tun m\u00fcssen. Au\u00dferdem erkl\u00e4ren wir, wann Sie eine klinische Studie\/Pr\u00fcfung durchf\u00fchren m\u00fcssen und wann eine Literaturrecherche ausreicht.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nK\u00fcnstliche Intelligenz (KI) in Medizinprodukten \u2013 MDR Leitfaden (2025)<\/h3>\r\nAuch MDR-Medizinprodukte d\u00fcrfen nat\u00fcrlich K\u00fcnstliche Intelligenz (KI) enthalten. Doch die Zulassung derartiger Produkte bringt eine Reihe von zus\u00e4tzlichen Herausforderungen mit sich. Hier gehen wir darauf ein, was Sie bei der Entwicklung von KI-Medizinprodukten beachten sollten.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nSoftware-Medizinprodukte ohne Qualit\u00e4tsmanagement & Regulatorik zulassen?<\/h3>\r\nDiGA und die Medical Device Regulation (MDR) bringen f\u00fcr Hersteller eine Menge Herausforderungen mit sich \u2013 von der Einrichtung eines Qualit\u00e4tsmanagementsystems (QMS) bis zur Erstellung der technischen Dokumentation. Kein Wunder, dass sich viele Unternehmen fragen, ob sie diese Komplexit\u00e4t auslagern k\u00f6nnen.\r\n\r\nDie gute Nachricht: Ja, das geht! Indem die Rolle des Legalherstellers an einen externen Anbieter \u00fcbertragen wird, lassen sich die regulatorischen Anforderungen komplett an eine dritte Partei auslagern.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\nErstattung & Verg\u00fctung von Software-Medizinprodukten<\/h2>\r\n\r\n\r\nDie Zulassung als Medizinprodukt nach MDR bef\u00e4higt Sie, Ihr Produkt auf dem Markt zu vertreiben. Das hei\u00dft aber noch nicht, dass Sie damit auch Geld verdienen.\r\n\r\nGerade im deutschen Gesundheitssystem ist es oft ratsam, einen Weg in die Erstattung durch Krankenkassen f\u00fcr Ihr Produkt zu finden. Hierf\u00fcr gibt es je nach Art des Software-Produkts eine Palette an Erstattungsoptionen.\r\n\r\nDie folgenden Leitf\u00e4den geben Ihnen einen \u00dcberblick \u00fcber wichtige Wege f\u00fcr Software-Produkte in die Erstattung.\r\nDigitale Gesundheitsanwendungen \u2013 unsere detaillierten Leitf\u00e4den<\/h3>\r\nDie Zulassung als DiGA stellt f\u00fcr Patienten-orientierte Applikationen bzw. DTx den wohl beliebtesten Weg in die Erstattung dar. Die Zulassung ist aber alles andere als einfach und bringt enorme regulatorische H\u00fcrden mit sich. Wir haben zu vielen Aspekten der Zulassung Fachartikel geschrieben, um Herstellern mit Zusatzinformationen zu unterst\u00fctzen.\r\n\r\n\u2192 Link zu allen Insights zur DiGA-Entwicklung und Zulassung in 2025<\/a>\r\nSelektivvertr\u00e4ge mit Krankenkassen: Die Alternative zu DiGA<\/h3>\r\nSelektivvertr\u00e4ge mit Krankenkassen eigenen sich f\u00fcr eine breite Palette von SaMD und sind ein popul\u00e4rer Weg in die Erstattung.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\nZertifizierung digitaler Kurse nach ZPP \u2013 Zentrale Pr\u00fcfstelle Pr\u00e4vention<\/h3>\r\nHersteller von Produkten, die sich auf die Pr\u00e4vention von Krankheiten konzentrieren, sollten sich mit der Zentralen Pr\u00fcfstelle Pr\u00e4vention auseinandersetzen. Dies stellt einen m\u00f6glichen Weg dar, die Kosten von derartigen Anwendungen (teilweise) zu verg\u00fcten.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\nDiPA: digitale Anwendungen f\u00fcr die Pflege<\/h3>\r\nDas Pendant zur DiGA in der Pflege sind die DiPA. Wie Sie DiPA potenziell in die Erstattung bringen, erfahren Sie hier.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\nErstattung von Software im GKV-Hilfsmittelverzeichnis (HMV)<\/h3>\r\nSoftware-Produkte, die sich als Hilfsmittel qualifizieren und z.B. eine Fehlfunktion des K\u00f6rpers ausgleichen, k\u00f6nnen potenziell ins Hilfsmittelverzeichnis aufgenommen werden. Dies stellt einen weiteren Weg in die Erstattung durch Krankenkassen dar.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\nWeitere aktuelle Informationen zur Entwicklung von Medizinprodukt-Software und DiGA<\/h2>\r\nIn die Erstellung der Leitf\u00e4den und Artikel haben wir viel Arbeit und Zeit investiert. Wir hoffen, dass sie Ihnen als Hersteller bei Ihren Herausforderungen Unterst\u00fctzung bieten k\u00f6nnen.\r\n\r\nAls zus\u00e4tzliches Angebot empfehlen wir Ihnen unseren Newsletter, in dem wir monatlich detaillierte Berichte zu aktuellen Themen im Bereich der und Medizinprodukt-Software- und DiGA-Entwicklung versenden.\r\n\r\nHier k\u00f6nnen Sie sich f\u00fcr den Newsletter anmelden: zum Newsletter<\/a>","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[44],"tags":[],"class_list":["post-21831","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-software-whitepaper-en"],"acf":[],"yoast_head":"\nMedical device software: Development and Approval in 2026<\/title>\n<meta name=\"description\" content=\"Key insights for the development and approval of medical device software in 2025. Practical guidelines for aspiring SaMD manufacturers.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/software-medical-device-development-approval\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical device software: Development and Approval in 2026\" \/>\n<meta property=\"og:description\" content=\"Key insights for the development and approval of medical device software in 2026. 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- \n
- 1.1 Formulation of the intended use for (software) medical devices<\/a><\/li>\n
- 1.2 Qualification: Is your software a medical device?<\/a><\/li>\n
- 1.3 Classification of software medical devices: MDR guidance<\/a><\/li>\n
- 1.4 MDR risk class I vs. IIa: Differences for software medical devices<\/a><\/li>\n
- 1.5 Class I software according to MDR \u2013 Is this still possible? (January 2025)<\/a><\/li>\n
- 1.6 IVDR software: Qualification and classification<\/a><\/li>\n<\/ul>\n<\/li>\n
- 2. Guidelines on aspects of SaMD development and approval<\/a>\n
- \n
- 2.1 Approval and certification of software medical devices (MDR)<\/a><\/li>\n
- 2.2 IEC 62304: Software life cycle processes for medical devices<\/a><\/li>\n
- 2.3 ISO 13485 \u2013 Guidelines on requirements and content<\/a><\/li>\n
- 2.4 Software as a medical device: 11 certification tips for manufacturers<\/a><\/li>\n
- 2.5 Validation of medical device software in accordance with MDR<\/a><\/li>\n
- 2.6 MDR guidance: Clinical evaluation of software medical devices<\/a><\/li>\n
- 2.7 Artificial intelligence (AI) in medical devices \u2013 MDR guidance (2026)<\/a><\/li>\n
- 2.8 Approval of software medical devices without quality management and regulation?<\/a><\/li>\n<\/ul>\n<\/li>\n
- 3. Reimbursement and remuneration for software medical devices<\/a>\n
- \n
- 3.1 Digital health applications \u2013 our detailed guidelines<\/a><\/li>\n
- 3.2 Selective contracts with health insurance companies: The alternative to DiGA<\/a><\/li>\n
- 3.3 Certification of digital courses in accordance with ZPP \u2013 Central Office for Prevention<\/a><\/li>\n
- 3.4 DiPA: digital applications for nursing care<\/a><\/li>\n
- 3.5 Reimbursement for software included in the GKV list of medical aids (HMV)<\/a><\/li>\n
- 3.6 Innovation funds and other subsidies for health software<\/a><\/li>\n
- 3.7 Cost reimbursement for software in hospitals<\/a><\/li>\n<\/ul>\n<\/li>\n
- 4. Further current information on the development of medical device software and DiGA<\/a><\/li>\n<\/ul>\n
1. Qualification and classification of software medical devices<\/h2>\n
<\/a><\/p>\nIntended purpose and classification of medical devices<\/p>\n
1.1 Formulating the intended purpose for (software) medical devices<\/h3>\n
At the beginning of every medical device development, the intended purpose should be formulated, which also serves as the basis for assigning the risk class according to MDR:<\/p>\n
\u2192 Link to article<\/a><\/p>\n
1.2 Qualification: Is your software a medical device?<\/h3>\n
Once you have formulated the intended purpose, the question arises: \u201cIs your software even a medical device according to the MDR?\u201d If this is not the case, you do not need to concern yourself further with the MDR.<\/p>\n
Read this article to find out for your product.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
1.3 Classification of software medical devices: MDR guidance<\/h3>\n
The risk class of a medical device makes a huge difference to the effort and costs you will need to invest in obtaining approval. You should therefore clarify this before starting product development.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
1.4 MDR risk class I vs. IIa: Differences for software medical devices<\/h3>\n
There are enormous differences in costs and timelines for product development, especially between risk class I and risk class IIa. What are the differences for you in practice?<\/p>\n
\u2192 Link to article<\/a><\/p>\n
1.5 Class I software according to MDR \u2013 Is that still possible? (January 2025)<\/h3>\n
We discuss which software medical devices may still fall under Class I as of 2025.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
1.6 IVDR software: Qualification and classification<\/h3>\n
If your software is intended for obtaining information through in vitro examinations, it may fall under the IVDR (In Vitro Diagnostics Regulation). Our guide explains how you can qualify and classify your software under the IVDR to ensure that it meets the relevant regulatory requirements.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2. Guides on aspects of SaMD development and approval<\/h2>\n
<\/a><\/p>\nTimeline: The path to medical device approval<\/p>\n
2.1 Approval & certification of software medical devices (MDR)<\/h3>\n
Here we provide a holistic overview of all aspects of the approval of Software as a Medical Device (SaMD).<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.2 IEC 62304: Software life cycle processes for medical devices<\/h3>\n
IEC 62304 is arguably the most important standard for the development of software medical devices. But how exactly can it be put into practice, and can it be combined with agile development?<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.3 ISO 13485 \u2013 Guidance on requirements and content<\/h3>\n
The quality management system of a SaMD manufacturer should be in line with ISO 13485 within the framework of the MDR. This is the most important standard for the conformity of quality management systems for medical devices.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.4 Software as a medical device: 11 certification tips for manufacturers<\/h3>\n
We have been developing software medical devices on a contract basis for other companies for over 10 years. We have written down our most important learnings and tips for future manufacturers here.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.5 Validation of medical device software according to MDR<\/h3>\n
Before a software medical device can be placed on the market, it must be formally validated. You can find out exactly what this means here.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.6 MDR Guide: Clinical evaluation of software medical devices<\/h3>\n
Clinical evaluation is at the heart of software medical device validation and poses major challenges for some manufacturers. We discuss what you need to do in this context. We also explain when you need to conduct a clinical study\/trial and when a literature review is sufficient.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.7 Artificial intelligence (AI) in medical devices \u2013 MDR guidance (2026)<\/h3>\n
MDR medical devices may, of course, also contain artificial intelligence (AI). However, the approval of such products brings with it a number of additional challenges. Here, we discuss what you should consider when developing AI medical devices.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
2.8 Approving software medical devices without quality management & regulations?<\/h3>\n
DiGA and the Medical Device Regulation (MDR) present manufacturers with a host of challenges \u2013 from setting up a quality management system (QMS) to creating technical documentation. No wonder many companies are wondering whether they can outsource this complexity.<\/p>\n
The good news is: yes, they can! By transferring the role of legal manufacturer to an external provider, the regulatory requirements can be completely outsourced to a third party.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
3. Reimbursement & compensation for software medical devices<\/h2>\n
<\/a><\/p>\nApproval as a medical device under the MDR enables you to market your product. However, this does not necessarily mean that you will earn money with it.<\/p>\n
In the German healthcare system in particular, it is often advisable to find a way to have your product reimbursed by health insurance companies. Depending on the type of software product, there are a range of reimbursement options available.<\/p>\n
The following guides provide an overview of important ways for software products to be reimbursed.<\/p>\n
3.1 Digital health applications \u2013 our detailed guides<\/h3>\n
Approval as a DiGA is probably the most popular way for patient-oriented applications or DTx to be reimbursed. However, approval is anything but easy and involves enormous regulatory hurdles. We have written specialist articles on many aspects of approval to provide manufacturers with additional information.<\/p>\n
\u2192 Link to all insights on DiGA development and approval in 2025<\/a><\/p>\n
3.2 Selective contracts with health insurance companies: The alternative to DiGA<\/h3>\n
Selective contracts with health insurance companies are suitable for a wide range of SaMD and are a popular route to reimbursement.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
3.3 Certification of digital courses according to ZPP \u2013 Central Testing Center for Prevention<\/h3>\n
Manufacturers of products that focus on disease prevention should look into the Central Testing Center for Prevention. This represents a possible way to (partially) reimburse the costs of such applications.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
3.4 DiPA: digital applications for nursing care<\/h3>\n
The counterpart to DiGA in nursing care is DiPA. Find out how you can potentially get DiPA reimbursed here.<\/p>\n
\u2192 <\/b>Link to article<\/a><\/p>\n
3.5 Reimbursement of software in the GKV medical aids directory (HMV)<\/h3>\n
Software products that qualify as medical aids and, for example, compensate for a malfunction of the body, can potentially be included in the medical aids directory. This represents another way to obtain reimbursement from health insurance companies.<\/p>\n
\u2192 <\/b>Link to article<\/a><\/p>\n
3.6 Innovation fund and other subsidies for health software<\/h3>\n
There are various public funding programs for manufacturers of digital health solutions, depending on the project focus, maturity, and target market. One of the most important and practical sources of funding in the German healthcare system is undoubtedly the G-BA Innovation Fund<\/b>, which specifically supports new forms of care and offers attractive opportunities for software projects related to healthcare.<\/p>\n
\u2192<\/b> Link to article<\/a><\/p>\n
In addition to the Innovation Fund, there are other national and European funding instruments that can reduce development, study, or implementation costs and strategically secure market entry. Our white paper \u201cFinancing and Funding Digital Health Products<\/b>\u201d provides a structured overview of relevant funding programs, typical funding logic, and strategic classification.<\/p>\n
\u2192<\/b> Link to article<\/a><\/p>\n
3.7 NUB as cost reimbursement for software products in hospitals<\/h3>\n
Could the NUB procedure (\u201cNew Examination and Treatment Methods\u201d) be a way to reimburse software innovations in hospitals? We analyzed over 2,400 NUB applications \u2013 with exciting results on the opportunities and limitations of cost reimbursement for digital solutions in hospitals.<\/p>\n
\u2192 Link to article<\/a><\/p>\n
4. Further current information on the development of medical device software and DiGA<\/h2>\n
We have invested a lot of work and time in creating these guidelines and articles. We hope that they will provide you, as a manufacturer, with support in meeting your challenges.<\/p>\n
As an additional service, we recommend our newsletter, in which we send out detailed monthly reports on current topics in the field of medical device software and DiGA development.<\/p>\n
You can subscribe to the newsletter here: to the newsletter<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"
The development of software medical devices is complex, and unfortunately, high-quality information on the subject is limited on the internet. We have been developing software medical devices for customers on a contract basis for over 10 years. During this time, we have implemented a wide range of app and software products (over 35 in total) […]<\/p>\n","protected":false},"author":22,"featured_media":24709,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"off","_et_pb_old_content":"In den letzten zehn Jahren haben wir eine Menge \u00fcber die Entwicklung von Software-Medizinprodukten gelernt. Dieses Know-how geben wir gerne in unseren Fachartikeln an (angehende) Entwickler von Software as a Medical Device (SaMD) weiter, damit nicht jeder dieselben Lektionen selbst machen muss.\r\n\r\nWir entwickeln Software-Medizinprodukte f\u00fcr Start-ups, Pharmaunternehmen und andere Firmen und begleiten daher den gesamten Entwicklungszyklus dieser Produkte \u2013 von der ersten Idee bis zur dauerhaften Zulassung und dar\u00fcber hinaus.\r\n\r\nIn diesem Beitrag m\u00f6chten wir Ihnen einen \u00dcberblick \u00fcber die Themen geben, zu denen wir bisher geschrieben haben.\r\n\r\nTipp: Wenn Sie neu in der Materie sind, macht es Sinn, dass Sie sich ganz einfach chronologisch von oben nach unten durch die Inhalte arbeiten.\u00a0<\/em>\r\n
Qualifizierung und Klassifizierung von Software-Medizinprodukten<\/h2>\r\n
\r\nZweckbestimmung und Qualifikation von Medizinprodukten<\/p>\r\n\r\n
Formulierung der Zweckbestimmung f\u00fcr (Software-)Medizinprodukte<\/h3>\r\nZu Beginn jeder Medizinprodukt-Entwicklung sollte die Zweckbestimmung formuliert werden, welche auch als Basis f\u00fcr die Zuordnung zur Risikoklasse nach MDR dient:\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Qualifizierung: Ist Ihre Software ein Medizinprodukt?<\/h3>\r\nNachdem Sie die Zweckbestimmung formuliert haben, stellt sich die Frage \u201eIst Ihre Software \u00fcberhaupt ein Medizinprodukt nach MDR?\u201c. Wenn dies nicht der Fall ist, m\u00fcssen Sie sich auch nicht weiter mit der MDR auseinandersetzen.\r\n\r\nLesen Sie diesen Artikel, um dies f\u00fcr Ihr Produkt herauszufinden.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Klassifizierung von Software-Medizinprodukten: MDR-Leitfaden<\/h3>\r\nDie Risikoklasse eines Medizinprodukts macht einen gewaltigen Unterschied f\u00fcr den notwendigen Aufwand und die Kosten, die Sie f\u00fcr die Zulassung investieren m\u00fcssen. Sie sollten dies also vor Beginn der Produktentwicklung abkl\u00e4ren.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
MDR Risikoklasse I vs. IIa: Unterschiede f\u00fcr Software-Medizinprodukte<\/h3>\r\nGerade zwischen Risikoklasse I und Risikoklasse IIa existieren enorme Unterschiede f\u00fcr Kosten und Zeitplan im Rahmen der Produktentwicklung. Was sind die Unterschiede f\u00fcr Sie in der Praxis?\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Klasse I Software nach MDR \u2013 Geht das noch? (Januar 2025)<\/h3>\r\nWir gehen darauf ein, welche Software-Medizinprodukte Stand 2025 noch in Klasse I fallen k\u00f6nnen.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Leitf\u00e4den zu Aspekten der Entwicklung und Zulassung von SaMD<\/h2>\r\n
\r\nTimeline: Der Weg zur Medizinproduktzulassung<\/p>\r\n\r\n
Zulassung & Zertifizierung von Software-Medizinprodukten (MDR)<\/h3>\r\nHier gehen wir einen holistischen \u00dcberblick \u00fcber alle Aspekte der Zulassung von Software as a Medical Device (SaMD) ein.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
IEC 62304: Software-Lebenszyklus-Prozesse von Medizinprodukten<\/h3>\r\nDie IEC 62304 ist die wohl zentralste Norm zur Entwicklung von Software-Medizinprodukten. Doch wie genau l\u00e4sst sich diese in die Praxis umsetzen und l\u00e4sst sich dies mit agiler Entwicklung vereinen?\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
ISO 13485 \u2013 Leitfaden zu Anforderungen und Inhalten<\/h3>\r\nDas Qualit\u00e4tsmanagementsystem eines SaMD-Herstellers sollte mit der ISO 13485 im Rahmen der MDR im Einklang stehen. Dies stellt die wichtigste Norm f\u00fcr die Konformit\u00e4t von Qualit\u00e4tsmanagementsystemen f\u00fcr Medizinprodukte dar.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n\r\n[sc name=\"form_in_blog_middle\"]\r\n
Software als Medizinprodukt: 11 Zertifizierungs-Tipps f\u00fcr Hersteller<\/h3>\r\nSeit \u00fcber 10 Jahren entwickeln wir Software-Medizinprodukte auf Auftragsbasis f\u00fcr andere Unternehmen. Wir haben hier unsere wichtigsten Learnings und Tipps f\u00fcr zuk\u00fcnftige Hersteller aufgeschrieben.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Validierung von Medizinprodukt-Software nach MDR<\/h3>\r\nBevor ein Software-Medizinprodukt auf den Markt gehen kann, muss es formal validiert werden. Was das genau bedeutet, erfahren Sie hier.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
MDR-Guide: Klinische Bewertung von Software-Medizinprodukten<\/h3>\r\nDie klinische Bewertung ist das Kernst\u00fcck der Validierung von Software-Medizinprodukt und stellt manch einen Hersteller vor gro\u00dfe Herausforderungen. Wir gehen darauf ein, was Sie in diesem Rahmen tun m\u00fcssen. Au\u00dferdem erkl\u00e4ren wir, wann Sie eine klinische Studie\/Pr\u00fcfung durchf\u00fchren m\u00fcssen und wann eine Literaturrecherche ausreicht.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
K\u00fcnstliche Intelligenz (KI) in Medizinprodukten \u2013 MDR Leitfaden (2025)<\/h3>\r\nAuch MDR-Medizinprodukte d\u00fcrfen nat\u00fcrlich K\u00fcnstliche Intelligenz (KI) enthalten. Doch die Zulassung derartiger Produkte bringt eine Reihe von zus\u00e4tzlichen Herausforderungen mit sich. Hier gehen wir darauf ein, was Sie bei der Entwicklung von KI-Medizinprodukten beachten sollten.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Software-Medizinprodukte ohne Qualit\u00e4tsmanagement & Regulatorik zulassen?<\/h3>\r\nDiGA und die Medical Device Regulation (MDR) bringen f\u00fcr Hersteller eine Menge Herausforderungen mit sich \u2013 von der Einrichtung eines Qualit\u00e4tsmanagementsystems (QMS) bis zur Erstellung der technischen Dokumentation. Kein Wunder, dass sich viele Unternehmen fragen, ob sie diese Komplexit\u00e4t auslagern k\u00f6nnen.\r\n\r\nDie gute Nachricht: Ja, das geht! Indem die Rolle des Legalherstellers an einen externen Anbieter \u00fcbertragen wird, lassen sich die regulatorischen Anforderungen komplett an eine dritte Partei auslagern.\r\n\r\n\u2192 Link zum Artikel<\/a>\r\n
Erstattung & Verg\u00fctung von Software-Medizinprodukten<\/h2>\r\n
\r\n\r\nDie Zulassung als Medizinprodukt nach MDR bef\u00e4higt Sie, Ihr Produkt auf dem Markt zu vertreiben. Das hei\u00dft aber noch nicht, dass Sie damit auch Geld verdienen.\r\n\r\nGerade im deutschen Gesundheitssystem ist es oft ratsam, einen Weg in die Erstattung durch Krankenkassen f\u00fcr Ihr Produkt zu finden. Hierf\u00fcr gibt es je nach Art des Software-Produkts eine Palette an Erstattungsoptionen.\r\n\r\nDie folgenden Leitf\u00e4den geben Ihnen einen \u00dcberblick \u00fcber wichtige Wege f\u00fcr Software-Produkte in die Erstattung.\r\nDigitale Gesundheitsanwendungen \u2013 unsere detaillierten Leitf\u00e4den<\/h3>\r\nDie Zulassung als DiGA stellt f\u00fcr Patienten-orientierte Applikationen bzw. DTx den wohl beliebtesten Weg in die Erstattung dar. Die Zulassung ist aber alles andere als einfach und bringt enorme regulatorische H\u00fcrden mit sich. Wir haben zu vielen Aspekten der Zulassung Fachartikel geschrieben, um Herstellern mit Zusatzinformationen zu unterst\u00fctzen.\r\n\r\n\u2192 Link zu allen Insights zur DiGA-Entwicklung und Zulassung in 2025<\/a>\r\n
Selektivvertr\u00e4ge mit Krankenkassen: Die Alternative zu DiGA<\/h3>\r\nSelektivvertr\u00e4ge mit Krankenkassen eigenen sich f\u00fcr eine breite Palette von SaMD und sind ein popul\u00e4rer Weg in die Erstattung.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\n
Zertifizierung digitaler Kurse nach ZPP \u2013 Zentrale Pr\u00fcfstelle Pr\u00e4vention<\/h3>\r\nHersteller von Produkten, die sich auf die Pr\u00e4vention von Krankheiten konzentrieren, sollten sich mit der Zentralen Pr\u00fcfstelle Pr\u00e4vention auseinandersetzen. Dies stellt einen m\u00f6glichen Weg dar, die Kosten von derartigen Anwendungen (teilweise) zu verg\u00fcten.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\n
DiPA: digitale Anwendungen f\u00fcr die Pflege<\/h3>\r\nDas Pendant zur DiGA in der Pflege sind die DiPA. Wie Sie DiPA potenziell in die Erstattung bringen, erfahren Sie hier.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\n
Erstattung von Software im GKV-Hilfsmittelverzeichnis (HMV)<\/h3>\r\nSoftware-Produkte, die sich als Hilfsmittel qualifizieren und z.B. eine Fehlfunktion des K\u00f6rpers ausgleichen, k\u00f6nnen potenziell ins Hilfsmittelverzeichnis aufgenommen werden. Dies stellt einen weiteren Weg in die Erstattung durch Krankenkassen dar.\r\n\r\n\u2192 <\/strong>Link zum Artikel<\/a>\r\n
Weitere aktuelle Informationen zur Entwicklung von Medizinprodukt-Software und DiGA<\/h2>\r\nIn die Erstellung der Leitf\u00e4den und Artikel haben wir viel Arbeit und Zeit investiert. Wir hoffen, dass sie Ihnen als Hersteller bei Ihren Herausforderungen Unterst\u00fctzung bieten k\u00f6nnen.\r\n\r\nAls zus\u00e4tzliches Angebot empfehlen wir Ihnen unseren Newsletter, in dem wir monatlich detaillierte Berichte zu aktuellen Themen im Bereich der und Medizinprodukt-Software- und DiGA-Entwicklung versenden.\r\n\r\nHier k\u00f6nnen Sie sich f\u00fcr den Newsletter anmelden: zum Newsletter<\/a>","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[44],"tags":[],"class_list":["post-21831","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-software-whitepaper-en"],"acf":[],"yoast_head":"\n
Medical device software: Development and Approval in 2026<\/title>\n<meta name=\"description\" content=\"Key insights for the development and approval of medical device software in 2025. Practical guidelines for aspiring SaMD manufacturers.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/software-medical-device-development-approval\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical device software: Development and Approval in 2026\" \/>\n<meta property=\"og:description\" content=\"Key insights for the development and approval of medical device software in 2026. 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- 2.2 IEC 62304: Software life cycle processes for medical devices<\/a><\/li>\n
- 1.2 Qualification: Is your software a medical device?<\/a><\/li>\n