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On July 29th, 2025, MedTech Europe published a position paper advocating for a more proportionate, risk-based approach to sampling under the IVDR. 📌 Key proposals include:• Targeting sampling efforts on high-risk and novel devices• Allowing flexibility in applying statistical methodologies• Promoting cooperation between industry and authorities to define realistic criteria The current one-size-fits-all approach to sampling is seen as impractical, particularly for SMEs, and may delay patient access to critical diagnostics. 👉 At Instituto Pedro Nunes (IPN), we guide IVD companies through IVDR implementation with tailored strategies that reflect real-world risks and resources. 🔗 Read the full position paper (EN)

On July 28th, 2025, TEAM-NB and NBCG-Med released a position paper proposing a new centralized governance structure for the EU medical device sector.The document recommends the creation of a Medical Device Coordination Office (MDCO) to: These proposals aim to strengthen consistency and efficiency across the MDR/IVDR framework, addressing long-standing challenges in the European regulatory landscape. 👉 At the Instituto Pedro Nunes (IPN), we closely follow regulatory developments and provide expert support to medical device companies throughout their compliance journey — from market access strategy to technical documentation. Our mission is to help innovative companies bring safe, effective medical devices to the EU market with confidence. 🔗 Read the full position paper (PDF)

The European Commission has released an updated Notified Body Survey analysing the progress of certification applications under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). 📌 Key takeaways from Q4 2024 data: This reinforces the importance of early regulatory planning, well-prepared technical documentation, and expert support throughout the certification journey. At MDRu, we work side-by-side with medical device manufacturers to:✔️ Prepare robust submissions✔️ Conduct gap analysis and technical reviews✔️ Support communication with Notified Bodies✔️ Anticipate and respond to clarification requests 📎 Download the full survey, here.  Follow MDRu’s LinkedIn for regular updates.

The European Commission has published the latest PMSV (Post-Market Surveillance and Vigilance) reporting forms, which apply to manufacturers of medical devices and in vitro diagnostic medical devices under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). These forms are intended to: There is a six 6 month transition period, as the new MIR Form 7.3.1 becomes mandatory as from November 2025. This gives the economic operators the necessary time to accommodate this change in their internal management systems and adapt, as appropriate, their associated procedures and documentation. 📎 Access the new forms and guidance, here. Follow MDRu’s LinkedIn for regular updates.

To complement its strategic vision for AI development, the European Commission has published a Questions and Answers (Q&A) document explaining its actions to promote AI talent, skills and literac across Europe.The Q&A outlines: This initiative reinforces the idea that technical capability must go hand in hand with ethical and regulatory awareness. At MDRu, we echo this approach – supporting AI-based medical solutions with guidance across development, testing and certification processes. 🔗 Read the full Q&A, here. Follow MDRu’s LinkedIn for regular updates.

In the end of april, INFARMED published a new guidance document regarding the requirements for language regarding the graphic user interface (GUI) for medical devices used by professionalsThe document clarifies expectations for: 📍 The update aims to support better compliance and harmonisation with EU regulatory frameworks and improve patient and user safety. 📄 The full documentation is available here. Follow MDRu’s LinkedIn for regular updates.

In the beginning of May, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach: the expanded use of unannounced inspections in foreign manufacturing facilities, including those producing foods, essential medicines and other medical products, including medical devices. In the beginning of May, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach: the expanded use of unannounced inspections in foreign manufacturing facilities, including those producing foods, essential medicines and other medical products, incluidng medical devices.This initiative reflects the FDA’s commitment to improving supply chain oversight and ensuring consistent manufacturing standards worldwide. According to the agency, unannounced inspections will: The expanded approach builds on the pilot implementations in India and China, regions that represent a substantial share of foreign manufacturing for the U.S. market. 📄 The full announcement is available here. Follow MDRu’s linked.in page for regular updates.

The European Commission has launched a public consultation to reinforce its “Apply AI Strategy – Strengthening the AI Continent”. This initiative is aligned with the forthcoming implementation of the AI Act and aims to guide Europe’s position as a global leader in trustworthy, secure, and human-centric artificial intelligence. The strategy seeks to identify actions to: This is a strategic opportunity for stakeholders across industries — including healthtech, medtech, education, and manufacturing — to help shape the EU’s digital future. 📅 Deadline: 04 June 2025 📄 The Call for evidence is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.

📌 This comprehensive document highlights key common pitfalls that often delay assessments and provides essential recommendations to ensure your submissions are clear, consistent, and aligned with regulatory expectations. Good examples include: 🔍 Best practices for structuring documentation;🧩 Enhanced consistency and alignment across all documentation;🔗 Clear rationale for GSPR applicability and conformity demonstration strategy;📄 Insightful recommendations for risk management activities; 📂 Improved evidence management throughout the entire technical documentation. 👉 If you’re involved in regulatory compliance for medical devices, this is a must-read to streamline your certification journey and better collaborate with Notified Bodies. 📄 The full paper is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.

🚨 The European AI Act is here – and it brings new challenges for AI-based medical devices! 🎯 Key highlights from the paper: 📆 The high-risk scope under article 6(1)(AIA) will apply starting August 2, 2027 🛡️ Strong emphasis on fundamental rights like privacy, data protection, non-discrimination, and human dignity🔍 Critical definitions: AI system, safety component, substantial modification and significant change🏛️ Urgent need for designation of AI-ready Notified Bodies🔁 Risks associated with overlapping requirements between MDR/IVDR and the AI Act 💡 The message is clear: a harmonised, pragmatic approach is needed to ensure that innovation in healthcare is not delayed, and that stakeholders are prepared for the regulatory convergence of AI and medical technology. 📄 The full paper is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.