Newsletter & Events - October CW 43/2025
Springer Gabler / Springer Nature Series in Healthcare Management and Innovation (available in November 2025)
Editors: Andreas Krämer · Cosimo Franco · Fabiola Hartung-Linz · Ellen Thom
📘 Medical Device Management – Chapter Spotlight #14, #15 & #16
✨ Part of the open access book: Medical Device Management – A Comprehensive Guide to Markets, Marketing, and Regulations
Medical Devices are an extremely important, versatile and complex product category within healthcare. However, compared to medicinal products, hospitals, medical staff, etc., there is much less general awareness and understanding of medical devices. This book illuminates different facets of medical devices in a holistic manner. It describes the complexity of the industry, markets, manufacturers, and numerous other stakeholders as well as related regulations, required competencies, and future trends. More specifically, it describes a range of products and innovations, safety risks and regulations, legal aspects, and certification processes. It also examines the market from the point of view of the manufacturer from start-ups to large companies and conglomerates. Finally, this book looks at the special role sustainability and ESG plays in the future of medical device innovation, production, and usage. Featuring industry case studies this book is ideal for individuals, from scientists to managers, interested in healthcare and who would like to understand the overall relevance of medical devices from different perspectives, specifically interactions, developments and dynamics between the different business areas and stakeholders. This book is open access.
💡 Chapter 14: Direct and indirect regulations for Medical Devices in Europe and Germany
Author: Marie-Isabel Dalügge, LL.M
📌Key insides: The chapter provides an overview of the direct and indirect regulation of medical devices in Germany and Europe, focusing on the transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It highlights the historical context, challenges faced, and the introduction of new regulations aimed at further enhancing safety, performance, and transparency. The chapter also discusses the current regulatory framework, key requirements, and the impact of broader European regulations such as REACH, RoHS, and GDPR on the medical device industry, as well as future developments.
💡Chapter 15: Medical Devices certification process in Europe
Authors: Armando Romaniello and Pietro Iannì
📌Key insides: To be placed on the market, Medical Devices—except those in the lowest risk class—must undergo conformity assessment to Regulation (EU) 2017/745 (MDR) by a Notified Body. These bodies are designated by Member States and must be independent, impartial, and competent. This chapter outlines the meaning and the rules of CE marking, the role of Notified Bodies and the conformity assessment process leading to CE certification. The voluntary standard ISO 13485 applicable to Medical Device manufacturers and related organizations is also described.
💡 Chapter 16: Legal implications for manufacturers and other stakeholders under MDR
Author: 𝗩𝗶𝗻𝗰𝗲𝗻𝘇𝗼 𝗦𝗮𝗹𝘃𝗮𝘁𝗼𝗿𝗲 of Simmons & Simmons
📌Key insides: Key Obligations under the EU MDR for Economic Operators
🏭 Manufacturers: Face expanded responsibilities for product compliance, post-market surveillance, and documentation under the MDR.
🤝 Authorised Representatives: Must verify manufacturer obligations, maintain access to technical documentation, and act as EU contact point.
🚛 Importers: Required to check CE marking, registration, and conformity before placing devices on the EU market.
🏬 Distributors: Must verify labeling, storage, and traceability to ensure only compliant devices reach the market.
⚙️ Shared Accountability: All economic operators are now jointly responsible for maintaining MDR compliance throughout the supply chain.
💡 In short: The MDR transforms supply chains into compliance networks — every actor plays a crucial role in safeguarding patient safety and market integrity.🎯EVENTS
🎯EVENTS
Recommended by LinkedIn
📢 Event Alert: “IVDR goes Digital”
💡 Join us on Nov 3, 2025 (16:30–20:00 CET) for an exciting RAPS Deutschland e.V. online networking event exploring how AI, Big Data & Cyber Security are reshaping IVD regulation under the #IVDR.
👉 Register now: raps-germany.de → Events section 🔒 Access link will be sent to registered participants only.
🗓️ Save the date & see you Online! 🚀
Trinational HealthTech Days #6 2025
Join us for the Trinational HealthTech Days on November 13th in Basel!
o Day 1 - Nov. 13: Conference & Networking Event, Basel, Switzerland
o Day 2 - Nov. 14: Online 1:1 Investor Meetings (by invitation only)
Organized by the @University of Basel , Baden Campus , the Life Science Accelerator Baden-Württemberg, and Quest for Health, the Trinational HealthTech Days connect innovative startups with leading investors, major corporates, and key stakeholders from Switzerland, France, and Germany. Join us on the 13th of November in Basel to foster cross-border collaboration in biotech, medtech, and digital health.
Please fill out the form to register: Trinational HealthTech Days #6 2025 - Airtable
Participants selected for the online 1:1 meetings on Day 2 will be contacted individually by the organizing team with further details.
📢Official launch at MEDICA - Leading International Trade Fair / COMPAMED 2025 - 17–20 November, Düsseldorf
👉 Meet the editors & authors in person at CQY Booth hall 10, booth E31
📍Book presentation will be on 18th November 2025, from 3 pm to 5 pm, Room #18, CCD (Convention Center Düsseldorf)
📖 Secure your copy and visit us at MEDICA - Leading International Trade Fair /Compamed – Open Access via Springer Gabler / Springer Nature
HAPPY TO SEE YOU SOON at our booth M&M Software GmbH & SEQLY Consulting 💖
#MedTechbyMM #LoveToWorkAtMM