The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016. This change simplifies compliance for medical device and IVD manufacturers and distributors, ensuring global harmonization and streamlined FDA premarket submissions effective February 2026.

The new version of the MIR 7.3.1 form, published by the European Commission, brings relevant changes for manufacturers of medical and in vitro diagnostic devices. The updated form is mandatory in the context of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), and is aligned with post-market surveillance (PMS) requirements and the future use of the EUDAMED system. Manufacturers must ensure that they use the new MIR model, with updated fields, IMDRF coding, EMDN nomenclature and structured data such as UDI-DI, Basic UDI and SRN.

The Swiss Federal Council recently approved a series of amendments to national legislation on medical devices, with a focus on strengthening patient safety, traceability through UDI and partial alignment with the European MDR Regulation. This legislative update aims to guarantee the continued safety and quality of medical devices marketed in Switzerland, even in the absence of an up-to-date Mutual Recognition Agreement with the European Union.

The new edition of the IMDRF Operating Procedures (Edition 13, 2025) clarifies the mechanisms for joining, developing and managing technical and regulatory documents in the medical devices sector. This document reinforces IMDRF's role in international harmonization, with a direct impact on the predictability of the rules applicable to manufacturers. The participation of regulatory authorities and industry stakeholders in these processes makes it possible to align technical requirements with global principles of compliance, safety and performance.

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.

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.

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.

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 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.

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.

The MHRA has released an update on the registration of medical devices in the UK, specifying the requirements for domestic and international manufacturers. The MHRA reinforces the need for compliance with the new surveillance and registration requirements, ensuring that medical devices and IVDs meet UK regulatory requirements before they are placed on the market.

Team-NB, the European association of Notified Bodies, has reinforced the importance of issuing certificates with conditions under the European Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). This approach allows innovative or orphan medical devices to obtain certification under specific conditions, such as more frequent post-market assessments, restriction of use to certain population groups or marketing limited to specialized medical institutions. Team-NB encourages Notified Bodies to apply this strategy to balance innovation and patient safety, ensuring faster access to new medical technologies.

Regulation (EU) 2025/327 establishes the European Health Data Space (EHDS), an innovative system that will enable the secure sharing of health data and cross-border access to Electronic Health Records (EHRs). This initiative strengthens digital interoperability in the European Union, ensuring that citizens can access their medical data in any Member State. For manufacturers of medical devices and digital health applications, the regulation imposes new rules on security, interoperability and data traceability, requiring products claiming compatibility with EHRs to comply with specific standards and, in some cases, to be registered with EUDAMED. The first obligations will come into force from March 2027, making it essential for companies in the sector to start preparing now to ensure regulatory compliance and access to the European market.

The IMDRF has released the 2025 update of the terminology for Reporting Adverse Events in Medical Devices, which includes new terms, modifications and removals in various annexes of the document. This revision aims to standardize and improve the reporting of adverse events, so that a globally harmonized classification is used to report and investigate incidents related to medical devices.

The MHRA has confirmed that four key EU regulations for the regulation of medical devices and in vitro diagnostic medical devices (IVDs) will be retained in the UK after May 26, 2025. The decision covers rules on common technical specifications, electronic instructions for medical devices, the use of tissues of animal origin and the supervision of approved bodies. In addition, the MHRA plans to update the legislation, replacing the reference to Regulation (EU) 207/2012 with the more recent Implementing Regulation (EU) 2021/2226. Meanwhile, further changes are expected with the upcoming "Pre-Market" legislation, which could impact the requirements for high-risk IVDs and remove temporary approvals for COVID-19 testing. Manufacturers and companies in the sector should follow these updates to ensure regulatory compliance in the UK market.

The proposed revision of IEC 62304 brings important changes for the development of software for medical devices and other healthcare applications. The new version expands the concept of Health Software to include solutions that assist in health management and monitoring, even without being classified as medical devices. Among the main changes are the simplification of the classification of software rigor, the removal of specific Quality System requirements and the revision of Risk Management, which no longer requires ISO 14971. In addition, the approach to legacy software will be reformulated, with guidelines transferred to an informative annex. As this update is still in the proposal stage, manufacturers should keep an eye on the changes and prepare for future adaptations.