news

The FDA’s Office of Combination Products (OCP) has issued final guidance titled “How to Prepare a Pre-Request for Designation (Pre-RFD).”   This guidance is designed to assist manufacturers in obtaining preliminary, non-binding feedback from the FDA regarding a product’s regulatory identity (drug, device, biologic, or combination product) and the appropriate Agency Center (CDER, CDRH, or CBER) responsible for review.   Key Highlights: Why this matters for regulated product developers:  How Instituto Pedro Nunes can support your organisation: More info, here.

In its latest Position Paper (October 2025), MedTech Europe urges regulators and Notified Bodies to adopt a risk-based and proportionate approach to Post-Market Clinical Follow-up (PMCF) activities for medical devices under the MDR 2017/745.  Manufacturers report growing pressure from authorities and Notified Bodies to conduct PMCF clinical investigations for nearly all devices — even long-established, low-risk technologies. MedTech Europe argues that this contradicts the MDR’s intent to align clinical evaluation with risk management and may unnecessarily strain healthcare professionals, patients, and innovation capacity.  Main concerns  MedTech Europe calls for:  A proportional PMCF system ensures safety remains verifiable — without compromising the availability of proven, safe devices.  More info: https://www.medtecheurope.org/resource-library/risk-based-approach-post-market-clinical-follow-up/  At IPN, we help manufacturers design and implement PMCF plans that are data-driven, proportional, and regulator-ready, integrating clinical evaluation, PMS, and risk management effectively. 

On October 2025, TEAM-NB published Version 2 of its Position Paper on Changes to Companion Diagnostic Devices under the IVDR 2017/746, Annex IX (5.2).  The paper provides detailed guidance to manufacturers and Notified Bodies on how to determine when a change to a Companion Diagnostic (CDx) requires prior approval and consultation with medicinal product authorities (e.g., EMA or national competent authorities).  Key insights:  This position paper enhances transparency and consistency across the conformity-assessment ecosystem, ensuring timely decision-making and continued patient safety.  At Instituto Pedro Nunes, we support CDx developers and IVD manufacturers in evaluating reportable changes, preparing technical documentation, and managing regulatory interactions with Notified Bodies and competent authorities.  Access the document here.

In October 2025, TEAM-NB and NBCG-Med submitted a joint position paper to the European Commission (DG CONNECT) in response to the Call for Evidence on the Digital Omnibus — part of the Commission’s effort to simplify digital legislation, including the AI Act.  Their contribution stresses that simplification should not compromise safety, integrity, or market fairness. Instead, it should strengthen the efficiency and sustainability of the Notified Body (NB) system that underpins the CE-marking framework.  Key recommendations from TEAM-NB & NBCG-Med:  The statement further calls for uniform assessment of Notified Bodies by Competent Authorities, recognising that fragmentation weakens trust, transparency, and equal conditions in the Single Market.  At Instituto Pedro Nunes we continue to support medical device manufacturers and innovators navigating EU regulatory transitions, we echo the importance of combining simplification with quality, traceability, and sustainability in the evolving AI regulatory landscape. Read the statement here.

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).