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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.

Instituto Pedro Nunes (IPN) and NOVA Medical School – Faculdade de Ciências Médicas (NMS) have established a partnership to strengthen the institutions’ ability to attract new partners or clients for their services in the field of medical devices. To promote the partnership among the industry, a unique event in Portugal was held on 28 June 2024 to explain to companies the journey involved in developing medical devices or IVDs, right through to commercialisation. The event also served to demonstrate the functionality of the partners (IPN, NMS and TUV-SU) to companies. TÜV SÜD is the leading European notified body for the certification of CE-marked medical devices. Through NOVA CRU, NMS supports companies and start-ups during the clinical research phase, with the following services: design and planning of the clinical research/performance study, development of the clinical research protocol, preparation and submission of clinical trials or studies (CS) to the competent authorities, monitoring and management, data analysis, technovigilance, and construction of computer software that responds to the specificities of Clinical Research. IPN, through its Medical Devices Regulatory — support unit, offers specialised regulatory and compliance services, helping companies navigate the regulatory journey that is necessary for the development and commercialisation of new technologies.

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