Medtech & Pharma Platform Association

Addressing the Gap in Clinical Strategy Discussion for MDR/IVDR Compliance 💡 As we continue to navigate the evolving regulatory landscape in MedTech,  it’s important to address a critical concern with the recent update to MDCG 2019-6 Revision 5. ⚖️ MedTech Europe, AESGP, Medtech & Pharma Platform Association, and COCIR wish to highlight an important aspect: While the update brings valuable guidance on structured dialogue, it overlooks the necessity for early alignment between manufacturers and Notified Bodies on clinical strategy. This gap in discussion could pose challenges in meeting clinical evidence expectations, which may impact the continuity of existing devices and the timely introduction of innovative technologies. 🔍 Key Considerations: Clinical strategy should be defined well ahead of MDR/IVDR submission, making it essential to have pre-submission discussions with Notified Bodies. 🗣️ Early alignment leads to higher quality dossiers and more efficient conformity assessments. ✅ Small and medium-sized enterprises (SMEs), in particular, may face significant challenges due to limited resources for reworking applications or gathering new data. 🏢 To address this, we encourage the European Commission and EU Member States to provide clarity on the ability for manufacturers and Notified Bodies to engage in pre-submission discussions about clinical strategy. In our paper, we outline practical proposals for how these discussions can be structured to improve the process, including transparency measures and necessary safeguards. We believe that fostering early collaboration and clarity is a vital step to ensuring both legacy devices and innovative technologies can meet regulatory requirements efficiently and on time. #MDR #IVDR #MedTech #ClinicalStrategy #RegulatoryCompliance #Innovation #SMEs #Healthcare #MedicalDevices #Collaboration 💬 #Regulation #MDR #IVDR #Innovation #ClinicalStrategy

We are delighted to welcome Sysmex Europe as the newest member of the Medtech & Pharma Platform Association (MPP)! With Sysmex on board, MPP’s dynamic cross-sector network grows even stronger, uniting medical device, diagnostic, pharmaceutical, and digital health leaders to drive innovation in healthcare. Together, we remain dedicated to shaping a progressive and balanced regulatory landscape—one that fosters safe, cutting-edge combined products and expands patient access to transformative healthcare solutions across Europe. Welcome, Sysmex! 🎉

We are delighted to announce that regenold GmbH has joined the Medtech & Pharma Platform Association (MPP) Association as its newest member. regenold GmbH's membership reinforces MPP Association's cross-sectoral nature, bringing together the medical device, diagnostic, pharmaceutical and digital sectors. In partnership with our members, the MPP Association aims to achieve a balanced regulatory framework for innovative and safe combined products and improve patients’ access to innovation for combined products in Europe.

🔗 Connecting Health Sectors for Better Patient Solutions 🔗 At the Medtech & Pharma Platform Association (MPP), one of our missions is to foster synergies across the medtech, diagnostic, pharmaceutical, and digital health sectors. We are focused on advancing health technologies through an integrated approach that includes: 🌐 Medicinal products for effective treatments 🌐 Medical devices for accurate drug delivery, diagnostic and monitoring 🌐 Digital platforms like medical software and mobile solutions for patient support Through collaboration, MPP is shaping a more holistic healthcare landscape where medicines, devices, and digital solutions come together to drive innovation and improve patient outcomes. This week, we take the time to thank you, our members, partners and followers, for your contribution to our work. Your drive. Your trust and solidarity. And your commitment to tomorrow’s safe, available and efficient health products for all patients’ well-being.

Season’s Greetings from the MPP Association! 🎄✨ As we approach the end of 2024, we would like to take a moment to thank all our members, partners, and collaborators for their continued support and engagement throughout the year. At the MPP Association, we remain committed to advancing the development and regulation of combined health technologies by: 🔹 Contributing to surveys and public consultations to identify key challenges and propose actionable recommendations. 🔹 Organizing expert events to deliver in-depth insights on the latest advancements in health technologies. 🔹 Hosting our flagship conference, bringing together industry leaders, experts, and innovators to share knowledge, showcase products, and foster valuable connections. We look forward to another year of collaboration, progress, and innovation. Wishing you a festive holiday and a Happy New Year filled with health, happiness, and success! 🎉 Let’s continue to drive impactful change in 2025!

EU Member States endorsed the COMBINE program, which aims to streamline combined studies involving medicinal products, medical devices and IVDs. Combined trials play a key role in the development of innovative treatments and in increasing access for patients. The Medtech & Pharma Platform Association has been actively involved in the COMBINE project and looks forward to be further contributing to the program along with other stakeholders. #Medtech #IVDs #MedicinalProducts

🌟 Join Us at the Medtech & Pharma Platform Association (MPP)! Are you passionate about improving healthcare and innovation in the pharma and medtech sectors? Become part of a dynamic community dedicated to enhancing access to combined products, integrating pharma, medtech, diagnostic and digital products, fostering collaboration across industries. 🤝 Why Join Us? 📍  Network with key industry players 📍  Share insights and your expertise 📍  Influence policy and drive change Together, we can make a real impact! Visit our website to learn more and become a member today: https://bit.ly/3K7yWvc #HealthInnovation #pharma #medicaldevices #medtech

🔬 MPP Association’s In Vitro Diagnostics Working Group 🔬 The Medtech & Pharma Platform Association's IVD Working Group tackles regulatory and policy issues related to in vitro diagnostics (IVDs), with a focus on IVDs used in combination with medicinal products. The WG led the preparation of our paper on the impact of IVDR on the use of in-house devices in clinical trials issued in October. 💡 Is this topic relevant to you? Join us in our efforts to accelerate patients’ access to safe and innovative health technologies and reinforce the competitiveness of the European healthcare industry. 🔎 Read the paper here: https://bit.ly/3OHWzNd Learn more about MPP activities or contact us directly: https://bit.ly/3K7yWvc #InVitroDiagnostics #IVDR #regulatorycompliance #medicaldevices #medtech

🌐 MPP Association's Connected Combined Products Working Group!🌐 Our Connected Combined Products WG is at the forefront of policy and regulatory discussions around combined products incorporating software, mobile platforms, and cloud applications. 📱📶 🔍 What’s our mission? To engage in ongoing EU discussions on strategic and regulatory frameworks like: ▪️ The Artificial Intelligence Act (entry into force in 2024) ▪️ The Multi-annual AI Workplan (2023-2028) ▪️ The European Medicines Agencies Network Strategy 2028 Our goal is to ensure proportionate and safe regulation for these cutting-edge products while supporting the integration of new technologies in healthcare. ✨ What are Connected Combined Products (CCPs)? We define a CCP as any medicinal product used with two or more components - such as devices, IVDs, software, mobile platforms, or cloud applications - designed to deliver medicine to patients and track essential data like medical adherence. Learn more about MPP activities or contact us directly: https://bit.ly/3K7yWvc

🔬 MPP Association's Combined Products Working Group! 🔬 The Medtech & Pharma Platform Association’s Working Groups create a collaborative space for members to tackle complex regulatory and policy issues in specific areas. The Combined Products Working Group (WG), focuses on the unique challenges of drug/device combinations in the EU regulatory landscape. 💼 What’s in focus? The WG dives into the policy and regulatory specifics of drug/device combinations, such as: ➡️ Integral combinations governed by Article 117 of the MDR ➡️ Cross-labeled and co-packaged drug/device combinations By actively contributing to EU-level discussions, we work to shape the regulatory landscape around MDR/IVDR assessments, ultimately helping to bring safe and innovative combined products to market efficiently. 💡How does MPP define “Combined Products”? We define a combined product as any use of a medicinal product (including biologics and ATMPs) with a device or diagnostic tool, designed for medical purposes. This category spans a wide range of products, including e-/m-health solutions. Learn more about the MPP’s activities and members: https://bit.ly/3K7yWvc