NOVACOS Law

🚨 Important News for the Medical Device Industry 🚨   🗓️ On 10 January 2025, the new Article 10a of the #MDR (Medical Device Regulation (EU) 2017/745) and of #IVDR (In Vitro Diagnostic Regulation (EU) 2017/746) enters into force. This article establishes reporting obligations for manufacturers who anticipate interruptions or discontinuations in the supply of in vitro diagnostics (IVD) and other certain medical devices.    What exactly does this mean?   🔍 Key Points of Article 10a MDR/IVDR:   📝 Advance Notification: Manufacturers must inform the relevant authorities and all affected economic operators at least six months in advance of any planned supply interruption or discontinuation if it is reasonably foreseeable that the interruption or discontinuation could result in serious harm or risk of serious harm to patients or public health in one or more Member States. 🗣️ Information Dissemination: Economic operators and healthcare institutions affected by the interruption must also promptly inform their stakeholders. 🛡️ Protecting Public Health: The aim is to prevent serious harm to patients and public health. 🇩🇪 Germany: Legislator implemented procedural rules for the information obligation according to Art. 10a MDR/IVDR in Sec. 7a Medical Device Implementation Act (“MPDG”).   The new Article 10a MDR/IVDR comes with challenges for the industry:   What action will the authorities consider in response to such information?  What grade of certainty is meant by “anticipation of interruption or discontinuation”?  What shall be the basis for the assessment of a manufacturer whether a notification is required?  In which cases is a breach of the six-month deadline justified?  How about confidentiality of the notification (business secrets)?  What will be consequences of an infringement of Article 10a MDR/IVDR?    🏢 What does the new Article 10a MDR/IVDR mean for businesses?    💡 Proactive Planning: Manufacturers should analyze their supply chains early and ensure to report interruptions or discontinuations according to Art. 10a MDR in a timely manner. 💡 Notification Obligation: Amendment of quality management system to establish a process to assess any facts which could lead to a notification obligation. 💡 Strengthening Collaboration: Close communication between manufacturers, suppliers, and authorities will become even more critical.   🔗 As part of our latest series #NOVACOSLawInsights: Life Sciences in Practice, we’ve highlighted the recently published Q&A document by the European Commission on Article 10a MDR/IVDR. Find the link to the Q&A document in the comments below!   #Medicaldevices #EURegulationsUpdate #HealthcareSupplyChain #NOVACOS #lifescience

🎉✨ Happy New Year 2025! ✨🎉   As the clock strikes twelve 🕰️ and a new year begins, we at #NOVACOS send our warmest wishes to you and your loved ones for a year overflowing with health, happiness, and remarkable success 🌟💼   #2024 has been a journey filled with growth, achievements, and moments to cherish. As we step into #2025, we’re filled with excitement and determination to embrace new challenges and opportunities, hand in hand with our incredible, growing team as well as valued partners and clients 🚀💪   Here’s to another year of collaboration, innovation, and shared success. Let’s make #2025 a year to remember—together! 🥂🎊   Wishing you joy, prosperity, and countless reasons to celebrate this year. 🎇Cheers to 2025!🥳   #HappyNewYear #NOVACOS #NewChallenges #lifescience #healthcare #2025

✨MERRY CHRISTMAS✨   As the holiday season unfolds, we at #NOVACOS would like to take this moment to wish you and your loved ones a magical Christmas Eve and peaceful, relaxing holidays🎄🎁 May these days bring a chance to pause, reflect, and recharge as the year comes to a close.   We are deeply grateful to our clients and business partners for the trust, collaboration, and shared success throughout this year. Your support has been instrumental, and we look forward with excitement to continuing our journey together in the year ahead🚀🌟   Let us embrace the spirit of the season, take a moment to review the milestones we’ve achieved, and set our sights on the opportunities of the coming year 🌠🎇   #merrychristmas #NOVACOS #healthcare #lifescience

🎄✨Last Saturday, we celebrated our #NOVACOS christmas party. ✨🎄 The evening kicked off with a Japanese cooking session, where we teamed up to showcase our sushi-rolling skills 🍣—some more masterfully than others. Afterwards, we indulged in sushi and other culinary delights 🍱.    As we dined, we took a moment to reflect on the highlights of the year, from the JUVE Awards to raft-building as summer team event and Carnival. But the night was far from over! We moved on to a cozy bar 🍹, where the new arrivals to Düsseldorf got their initiation into the world of Killepitsch alongside the usual drinks. Let’s just say, it was a love-it-or-leave-it experience for some! What a way to wrap up the year! 🎉🥂   #christmas #christmasparty #highlightsoftheyear #NOVACOS #healthcare #lifescience Maria Heil Christian Hübner Dr. Christian Stallberg Dr. Marc Oeben Alexander Natz Guram Gobechia Dr. Julia Eickbusch Christian Binder Savannah Schulte, LL.M. Kathrin Leitges Dr. Luis Kemter

🌟 Our New Series: „NOVACOS Law Insights: Life Sciences in Practice“ 🌟 We are excited to launch our brand-new series where we will regularly share key updates, insights and expert perspectives on the latest developments in health law. Stay informed and ahead of the curve with us! 🩺📜   For the premiere edition of “NOVACOS Law Insights: Life Sciences in Practice”, we have selected four recent health law related topics we found particularly important:   🇪🇺 Reprocessing and Reuse of Single-Use Devices in the EU: European Commission Report 📅 On November 29, 2024, the European Commission released a report addressing the reprocessing of single-use devices. 📊 The report presents data on the implementation of Article 17 of the Medical Devices Regulation (MDR) and highlights the challenges involved in reprocessing single-use devices. 📖 Read the full report in multiple languages here: https://lnkd.in/emfjYFDq   🇪🇺 European Commission Revises Guidance on Sampling of Medical Devices and IVDs (MDCG 2019-13 rev.1) 📅 On December 17, 2024, the European Commission published the revised version of its guidance on sampling for medical devices (Classes IIa and IIb) and in-vitro diagnostic devices (Classes B and C). 📋 The document elaborates on the criteria for creating and maintaining sampling plans, as well as the role of Notified Bodies in ensuring compliance with Annex IX, Chapter II of the MDR and IVDR. The 2024 revision specifically updates Footnote No. 10, reflecting the ongoing refinement of regulatory practices.. 🔗 Read the full MDCG 2019-13 rev.1 here: https://lnkd.in/efgAWXxm   🇪🇺 Regulation (EU) 2024/1860: Updated Q&A Document on Article 10a MDR and IVDR 📅 At the end of October 2024, the European Commission published an updated Q&A document addressing the practical implementation of the information obligations under Article 10a MDR and IVDR. This concerns obligations around discontinuation or interruptions in the supply of certain medical devices and in vitro diagnostics. 🔄 This document has now been updated and can be accessed here: https://lnkd.in/epPNZuWd   🇩🇪 KHVVG: New Hospital Care Improvement Act Published in Germany  📅 On December 12, 2024, the Krankenhausversorgungsverbesserungsgesetz (KHVVG) officially came into force in Germany. 🏥 The new law focuses on enhancing treatment quality in hospitals, improving access to care —particularly in rural areas —, and reducing bureaucratic burdens and economic pressures on hospitals.    #NOVACOSInsights #HealthLaw #MedicalDevices #RegulationUpdates #HealthcarePolicy #NOVACOS #healthcare #lifescience

🚨 Challenges for market players! New EU Product Safety Regulations in effect! 🚨 Starting today – 13 December 2024 – the new EU Product Safety Regulation (GSPR) (EU) 2023/988 takes effect, replacing outdated national laws and the General Product Safety Directive (2001/95/EG) with uniform rules across all EU Member States.   What’s new?   🌍 Direct applicability in all EU countries 🔒 Expanded and stricter obligations for all market players, including non-EU manufacturers 🤖 Inclusion of digital products, AI and modern sales models like online marketplaces 🚫 No application to certain types of products (e.g., medicinal products or food)   This modernized framework is designed to ensure that safe consumer products reach the market, keeping pace with technology and protecting consumers across the EU.    For economic operators, the GPSR entails numerous new obligations for the pre- and post-market activities. Product compliance management systems will become even more important in the future. We prepared a Q&A on the new GPSR: https://lnkd.in/en5yUMMi  Furthermore, you can contact Dr. Marc Oeben for further questions.   The EU GPSR is available here: https://lnkd.in/eHwuuGCc   #GPSR #ProductSafety #EUCompliance #DigitalAge #NOVACOS #lifescience #healthcare

🎉 A warm welcome to the team, Dr. Luis Kemter! 🎉 We are thrilled to have Dr. Luis Kemter join the #NOVACOS team as our newest associate!   With a law degree from Bonn, a doctorate in criminal law, and experiences in Data, Privacy, and Cybersecurity, as well as expertise in healthcare law and M&A from his time in Madrid, Luis brings valuable knowledge and skills to our firm. His numerous publications in criminal and healthcare law reflect his dedication.    Since his admission to the bar in October 2024 he enriched our #NOVACOS team and we look forward to achieving great things together! 💼⚖️   If you want to know more about Luis: https://lnkd.in/g26GtDHh   #whoweare #aboutus #ourteam #lifescience #healthcare #NOVACOS

📚We are excited to share that our colleagues Christian Hübner and Christian Binder have published an article on the hot topic of environmental “green claims”.   With the 'Green Claims Directive', the EU-Commission is proposing stricter rules for environmental claims: In the future, according to the draft directive, companies would face comprehensive substantiation obligations for environmental claims and must have their environmental claims externally verified in advance - a novelty! In their article 'Ex-Ante Zertifizierung und Substanziierung von umweltbezogener Werbung nach dem Entwurf der Green Claims-Richtlinie: Unverhältnismäßiger Bürokratismus odersinnvolle Ergänzung?' in #MPR (5/2024, p. 185 - 224), Christian Hübner and Christian Binder take a closer look at the Commission's draft and the recent Council's amendments, taking particular account of issues that could be of interest to the medical device and pharmaceutical industry, above all the planned ex-ante certification of environmental claims.  Read the full article on our website: https://lnkd.in/ezSVz6qa    #nachhaltigkeit #sustainability #GreenClaims #medizinprodukte #EURecht #healthcare #NOVACOS #lifesciences

🎉 Welcome Back, Kathrin! 🎉 We are delighted to announce that Kathrin Leitges has rejoined the #NOVACOS team as a fully qualified lawyer. Kathrin studied law at Heinrich-Heine-University Düsseldorf, specializing in medical law. During her legal clerkship, she gained experience at the European Commission and further healthcare-related stages, specializing in healthcare, life sciences, and medicinal product regulation. Now officially admitted to the bar, she brings her expertise and skills back to #NOVACOS. We’re excited to continue this journey together! 💼⚖️   If you want to know more about Kathrin: https://lnkd.in/e-kePvpW   #whoweare #aboutus #ourteam #newteammember #lifescience #healthcare #NOVACOS

The workshop provided very interesting insights into the establishment of a European health data ecosystem and a great opportunity to bring experts and bright minds together. Even if the project is facing a lot of (technical, content, legal) challenges, the value of the health data ecosystem for the patients' health and innovation in the EU will be worth it. #EHDS #healthdata #healthcare #lifesciences #NOVACOS