The new EUDAMED guide for legacy devices is an essential tool for medical device manufacturers who continue to operate under the previous MDD and AIMDD directives, but want to remain compliant during the transition period to Regulation (EU) 2017/745 (MDR). The document covers the assignment of EUDAMED DI and EUDAMED ID codes, the structured registration of legacy devices, the management of certificates and linking to already registered regulated devices. With practical guidelines and examples of accepted formats, this guide contributes to strengthening the traceability, compliance and regulatory security of legacy devices still on the European market.

The new EUDAMED user guide for Unique Identifier (UDI) devices is an indispensable reference for all medical device manufacturers who want to ensure compliance with the MDR and IVDR regulations. The document covers aspects such as registering Basic UDI-DI and UDI-DI, managing data in EUDAMED, connecting to legacy devices, and updating versions. It also includes crucial information on requirements for accessing the EUDAMED platform, user profiles, and the procedures for structured data submission. This guide is essential for ensuring an effective compliance strategy in the European regulatory context.

There's a symbol update you can't ignore. With the release of Amendment 1 to ISO 15223-1, the European Authorized Representative symbol is changing from EC REP to EU REP.

Team-NB 's official position paper on the implementation of the AI Act offers key guidance for manufacturers of medical devices with artificial intelligence. The document analyzes the integration between the AI Regulation and the requirements already established by the MDR and IVDR, underlining the classification of devices with AI as high-risk systems.

The new version of Team NB's good practice guide for submitting technical documentation under Regulation (EU) 2017/745 (MDR) provides clear guidance for medical device manufacturers. The document addresses the structuring of dossiers, the consistency of data, common mistakes to avoid and the importance of effective communication with Notified Bodies.

Implementing Decision (EU) 2025/681 introduces six new harmonized standards under the Medical Devices Regulation (MDR), directly impacting manufacturers of single-use medical gloves, sterile devices and ambulance patient transport equipment. Compliance with these standards allows presumption of conformity with the essential requirements of the MDR, facilitating CE marking and access to the European market. Smart MDR supports manufacturers in reviewing technical documentation, assessing regulatory impact and adapting processes to the new European legislation.

Smart MDR offers support via WhatsApp for manufacturers of medical devices, IVDs and medical device software looking for support with CE Marking and European regulations. Talk to an expert consultant and accelerate access to the European market with confidence.

With the entry into force of the IVDR, rapid antigen tests for COVID-19 are now classified as Class D devices, requiring assessment by a Notified Body.

AI in healthcare has transformative potential, but it also raises ethical and regulatory challenges. The WHO has published guidelines on the governance of AI, with a focus on large-scale multimodal models (LMMs). These systems can revolutionize medical diagnosis, scientific research and drug development, but it is essential to guarantee data security, transparency of algorithms and equity of access.

The FDA 's new guidance on the evaluation of gender-specific data in clinical studies with medical devices highlights the importance of including men and women in a representative way in trial samples. The analysis of gender-differentiated data makes it possible to identify possible variations in the efficacy and safety of medical devices, contributing to a more rigorous and inclusive evaluation.

The FDA has released the March 2025 edition of the "Study Data Technical Conformance Guide", an essential document for ensuring regulatory compliance in the submission of standardized data in clinical studies. The new guidelines affect processes such as INDs, NDAs, ANDAs and BLAs, ensuring that manufacturers follow the standards of the FDA Data Standards Catalog. Compliance with these rules is key to avoiding delays and guaranteeing acceptance of electronic submissions to CDER and CBER.

ANVISA 's latest report on the Potential Risk Monitoring and Intervention Pilot Project highlights a strategic, data-based approach to reducing health risks in priority health services such as surgical centers, ICUs and ILPIs.

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The new edition of IMDRF-NCAR WG/N14 introduces clearer rules for Field Notifications of Corrective Action (NCARs), reinforcing the safety of medical devices.

The IMDRF has published a Playbook for the evaluation of Artificial Intelligence and Machine Learning (AI/ML) medical devices, addressing safety, efficacy and regulatory requirements. Global harmonization of these medical devices is essential to ensure transparency, reliability and compliance.

Team-NB has released a report on technical documentation training in the context of MDR 2017/745, which is essential for medical device manufacturers. The data shows that only 50% of SMEs have submitted a technical dossier, while 54% of large companies have already updated at least half of their documentation. The report highlights the need for continued support for small and medium-sized enterprises.

Anvisa has opened Public Consultation No. 1,313/2025 to receive suggestions on the Normative Instruction that regulates the transmission and management of the UDI Brasil database, as provided for in RDC No. 591/2021. The regulation will detail the technical and operational criteria for data transmission, making it essential for companies in the sector to be prepared for the future obligation.

MDCG has published Revision 4 of MDCG 2020-16, updating the classification of in vitro diagnostic medical devices (IVDs) in accordance with IVDR Regulation (EU) 2017/746. Among the main changes is the reclassification of SARS-CoV-2 tests. In addition, adjustments have been made to the classification of blood, tissue and organ screening tests, as well as clarifications for complementary diagnostics and self-tests.

ISO has published new standards and updates for medical devices, health technologies and pharmaceuticals. Among the main standards are requirements for respiratory equipment, risk management in heart valves, cybersecurity in telehealth and digital integration in health. These updates aim to improve the safety, efficacy and regulatory compliance of medical products globally.

The FDA has released a new document on the use of Artificial Intelligence (AI) in the life cycle of medical products, reinforcing the need for transparency, safety and regulatory compliance. The FDA has identified four priority areas: global collaboration to protect public health, support for regulatory innovation, development of standards and best practices, and continuous monitoring of AI performance. The guidelines address everything from algorithm evaluation and bias mitigation to the resilience and cybersecurity of AI-based medical products. This initiative reinforces the FDA's commitment to responsible innovation, ensuring that AI applied to health contributes to medical advances without compromising patient safety.