The FDA has released updated draft guidance on the eCopy Program, clarifying current requirements for electronic device submissions. As eSTAR becomes the new standard, understanding when eCopy rules still apply is critical for medical device manufacturers.

The European Commission has published the results of its second survey of Economic Operators, revealing the main challenges manufacturers face under the MDR and IVDR. The findings highlight increased administrative burden, regulatory complexity and supply chain challenges, offering important insights for companies placing devices on the EU market.

The European Commission has confirmed that four core EUDAMED electronic systems—economic operator registration, UDI and device registration, notified bodies and certificates, and market surveillance—are fully functional. This triggers mandatory transition timelines and introduces significant new obligations for medical device manufacturers.

Health Canada has adopted the IMDRF Table of Contents (ToC) structure for medical device submissions, streamlining dossier preparation and supporting global regulatory convergence. The updated guidance outlines requirements for pre-market and post-market submissions and clarifies expectations for electronic filing, templates and documentation. Essential reading for manufacturers targeting the Canadian market.

The MHRA has published updated guidance on clinical investigations for medical devices, detailing the requirements manufacturers must meet when planning and conducting investigations in Great Britain. The update strengthens documentation expectations, safety requirements and regulatory oversight, making it essential for all manufacturers preparing UK submissions.

The European Commission has launched a Call for Evidence for its Digital Fitness Check, a major evaluation of EU digital legislation and its impact on competitiveness, innovation and administrative burden. This review is particularly relevant for medical device manufacturers facing overlapping digital, cybersecurity and data compliance obligations across EU rules.

The TGA has released an updated consolidated guidance on the Essential Principles for medical devices, outlining key regulatory, safety, and performance requirements manufacturers must meet to supply devices in Australia. This update strengthens expectations for risk management, clinical evidence, design and manufacturing controls, and technical documentation, reinforcing compliance obligations for medical device manufacturers targeting the Australian market.

Swissmedic has released updated guidance on the requirements for obtaining export certificates (Free Sales Certificates) for medical devices, introducing clearer rules for manufacturers on documentation, conformity evidence, product grouping, and submission procedures. The revised framework is essential for manufacturers exporting devices to global markets that require FSCs as part of their regulatory registration.

Health Canada has released Phase II of its Medical Device Establishment Licensing (MDEL) Modernization Framework, introducing enhanced compliance expectations, strengthened oversight of foreign manufacturers, updated documentation requirements and a stronger focus on post-market safety. These changes are essential for manufacturers exporting medical devices to Canada.

The FDA has released its final guidance on Computer Software Assurance (CSA) for production and quality system software, introducing a risk-based, streamlined approach to validating software used in manufacturing and quality operations. The updated framework helps manufacturers reduce unnecessary documentation, focus validation efforts on functions that impact product quality and patient safety, and accelerate the adoption of automated and digital technologies while remaining fully compliant with FDA requirements.

The FDA has issued a new draft guidance that updates the scientific principles for demonstrating biosimilarity. The document clarifies when strong analytical similarity data, supported by comparative human pharmacokinetic and immunogenicity assessments, may be sufficient to demonstrate biosimilarity without requiring a comparative clinical efficacy study. This updated approach can help manufacturers reduce development timelines and costs, while placing greater emphasis on robust analytical packages, sensitive PK study designs and a clear, risk-based justification aligned with FDA expectations.

The new MDCG 2025-8 guidance provides detailed rules for manufacturers on how to implement the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. Covering UDI assignment, design parameter grouping, EUDAMED registration and vigilance obligations, this document is essential for manufacturers of highly individualised devices seeking MDR compliance and improved traceability.

The MHRA has released updated guidance for clinical investigations of medical devices in the UK, outlining new requirements for manufacturers, including application validation, safety reporting, UKCA/CE/CE UKNI considerations, and updated processes for studies in Great Britain and Northern Ireland. Medical device manufacturers must review these regulatory changes to maintain compliance, ensure timely clinical investigation approvals, and prepare robust technical documentation aligned with UK and EU regulatory frameworks.

Swissmedic’s updated guidance on PSUR Signal Management sets a higher standard for pharmacovigilance in Switzerland. By aligning with EU Regulation 2019/6 and VICH GL 29, it requires manufacturers to strengthen PSUR reporting, signal evaluation, and safety data traceability. For medical device and IVD producers, this shift underscores the importance of robust post-market surveillance and regulatory readiness. Smart MDR supports companies in navigating these evolving frameworks efficiently and confidently.

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 newly published ANVISA manual provides updated guidance for the regularisation of medical devices and in vitro diagnostic products in Brazil. Covering topics such as device classification, documentation, GMP certification, and use of the Solicita system, this manual is essential for medical device and IVD manufacturers looking to expand into Brazil. By ensuring regulatory compliance, manufacturers can achieve faster access to Brazil’s large and growing healthcare market.

The latest FDA guidance on decentralized clinical trials (DCTs) marks a significant development for IVD and medical device manufacturers. By incorporating digital health technologies, remote monitoring, and home-based device usage, DCTs allow for enhanced trial flexibility and patient accessibility. This guidance clarifies regulatory expectations, especially around investigational product distribution, informed consent, and oversight, supporting innovation while maintaining compliance.

As novas normas harmonizadas para dispositivos médicos (EN 13795-1:2025, EN 13795-2:2025, EN 14683:2025 e EN 14180:2025) representam uma atualização fundamental para os fabricantes que operam sob o Regulamento Europeu de Dispositivos Médicos (MDR). Esta decisão da Comissão Europeia impacta diretamente o processo de Marcação CE, a avaliação da conformidade e o controlo de qualidade de produtos como máscaras médicas, vestuário cirúrgico e esterilizadores.

A MHRA lançou o AI Airlock Sandbox, um programa-piloto inovador que visa acelerar a regulamentação de dispositivos médicos com Inteligência Artificial (IA). Esta iniciativa estabelece um novo padrão para a avaliação de conformidade CE, em linha com o MDR, IVDR e o futuro AI Act europeu. Para fabricantes e distribuidores de dispositivos médicos e IVD, compreender este modelo de sandbox regulamentar é essencial para garantir conformidade, rastreabilidade e segurança dos algoritmos de IA em soluções de software médico (SaMD). A Smart MDR apoia empresas na adaptação a estas novas exigências e na integração segura de IA nos seus produtos.

A ISO e a IEC estão a desenvolver e atualizar várias normas internacionais que afetam diretamente o setor dos dispositivos médicos e IVD, incluindo temas como qualidade, cibersegurança e software médico. Estas normas, como a ISO 13485, ISO/IEC 82304-2 e IEC 81001-5-1, reforçam o compromisso global com a segurança, interoperabilidade e inovação responsável.