Luiza Almeida

In September 2025, the FDA issued its guidance “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.” What’s new? Why it matters for diagnostics and regulated quality environments? If you want to explore how this FDA guidance applies to your diagnostics business or IVD development, Instituto Pedro Nunes is here to help. Read more here.

On September 24, 2025, the FDA released its final guidance “Computer Software Assurance for Production and Quality System Software.” What’s new? Why it matters for medical device and regulated quality environments? How MDRu can support your organization? If you want to understand how this new guidance can be applied to your business, MDRu is ready to help. Access the doc here.

The Medical Device Coordination Group (MDCG) has released a new draft guidance document (MDCG 2025-X) clarifying the requirements for trend reporting under the EU Regulations on Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR). Trend reporting is a cornerstone of post-market surveillance (PMS) and requires manufacturers to monitor and report any statistically significant increase in non-serious incidents, expected undesirable side effects, or expected erroneous results. These findings can impact the benefit-risk analysis and ultimately patient safety. Why this matters for manufacturers: 📖 Read the draft guidance here.

The newly reviewed Team-NB Best Practice Guidance for Submission of  Technical Documentation under IVDR (Sept 2025) provides clarity on technical documentation requirements according to the In Vitro Diagnostic Medical Devices Regulation – IVDR (EU 2017/746). This guidance supports manufacturers in preparing technical documentation under Annexes II and III, helping to: 🔍 What’s New in Version 2? At Instituto Pedro Nunes (IPN), we help companies align their submissions with best practices—strengthening compliance and reducing approval risks. 🔗 Read the official document

Between January 2024 and May 2025, PwC EU Services and Open Evidence conducted a comprehensive study for DG SANTE on the state of artificial intelligence (AI) in healthcare across the European Union. 📊 The report identifies key needs where AI could help address challenges related to:• Growing demand for healthcare• Administrative burden• Delays in diagnosis and treatment• Disparities in healthcare access Despite notable progress in AI-driven healthcare innovations, adoption remains slow. The study outlines several barriers that still need to be addressed: 🔧 Technological & Data Challenges— Lack of interoperability, outdated IT infrastructure, and limited transparency in AI models 📜 Regulatory Complexity— Navigating overlapping regulations and ensuring compliance 💰 Organisational & Financial Barriers— Absence of clear financing and reimbursement frameworks, and difficulty in assessing local added value 🧠 Social & Cultural Concerns— Ethical implications and trust in AI reliability 🌐 Countries that have successfully deployed AI in healthcare offer valuable lessons and good practices that can support overcoming these challenges. 👉 At Instituto Pedro Nunes (IPN), we help innovators in digital health and medtech navigate the EU regulatory landscape — including MDR, IVDR, and the new AI Act. 🔗 Read the full report (PDF)

On August 1st, 2025, the European Commission released an updated Notified Bodies survey, providing detailed data on applications, refusal reasons, and average certification timelines under MDR and IVDR. 📊 MDR highlights:• Gradual increase in issued certificates, but still far below application volumes• Main reasons for refusals: “Applications not complete” (39%) and “Outside the scope of NB designation” (26%)• Average time from contract signature: - MDR QMS: 51% of NBs take 13–18 months; 36% take 6–12 months - MDR QMS + Product: Longer — 60% take 13–18 months; 29% take 19–24 months• On average, 58% of the process time is with the manufacturer, and 42% with the NB 📊 IVDR highlights:• Gradual increase in certificates issued, but still far below the number of applications• Reasons for refusals vary widely• Average time from contract signature: - IVDR QMS: 55% of NBs take 6–12 months; 27% take 13–18 months - IVDR QMS + Product: Longer — 64% take 13–18 months; 9% take 19–24 months• On average, 61% of the process time is with the manufacturer, and 39% with the NB 👉 At Instituto Pedro Nunes (IPN), we help medical device and IVD companies achieve certification with optimised documentation, effective strategies, and strong engagement with Notified Bodies. 🔗 Access the full survey results (PDF).

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.