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The FDA has released a draft guidance aligning U.S. Quality Management System (QMS) requirements with ISO 13485:2016.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.

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.

A FDA publicou uma nova orientação sobre políticas de enforcement aplicáveis a testes de diagnóstico in vitro durante emergências de saúde pública, ao abrigo da secção 564 do FD&C Act. O guia define os critérios para o início e término destas políticas, oferecendo previsibilidade aos fabricantes em situações críticas, sem comprometer a segurança pública.

A Comissão Europeia lançou uma consulta pública (Call for Evidence) para a revisão direcionada do MDR e IVDR. O objetivo é simplificar processos, reduzir encargos administrativos e reforçar a previsibilidade regulamentar, sem comprometer a segurança dos pacientes. A revisão incidirá sobretudo em requisitos proporcionais para PME e dispositivos de baixo e médio risco.

A Health Canada publicou um relatório sobre a redução da burocracia regulamentar, destacando medidas para simplificar processos, reduzir custos e apoiar a inovação no setor da saúde. As iniciativas incluem digitalização de submissões, harmonização internacional e eliminação de requisitos redundantes, mantendo sempre a segurança dos pacientes como prioridade.

O Manual GQUIP 2025 da ANVISA fornece diretrizes atualizadas para a gestão da qualidade de dispositivos médicos e produtos para diagnóstico in vitro no Brasil. Com foco em fabricantes, distribuidores e importadores, o documento aborda ações corretivas, vigilância pós-comercialização, conformidade regulatória e gestão de não conformidades. A nova versão reforça a importância de práticas preventivas para garantir a segurança dos produtos no mercado brasileiro.

The new MDCG 2025-6 guide, published in June 2025, clarifies the joint application of the AI Act and the European MDR/IVDR regulations for medical devices and IVDs with artificial intelligence systems. The document addresses classification, risk management, life cycle, technical documentation and post-market monitoring. Smart MDR supports manufacturers in integrating these requirements into their quality management system and preparing for audits.

The June 2025 report on the coverage of MDR and IVDR designation codes by notified bodies provides an updated view on the availability of designated bodies for specific categories of medical devices and in vitro diagnostic medical devices. It identifies critical areas with lower coverage, such as active implantable medical devices (codes MDA 0101 to MDA 0104) and devices originating from human tissues (MDS 1002), as well as IVDs for blood and tissue typing (codes IVR 0101 to IVR 0202). For medical device manufacturers seeking certification under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, analysis of these codes is essential to plan the submission of applications to notified bodies with adequate coverage.

With the publication of the preliminary SIUD manual, Anvisa has begun the official implementation of the Unique Identification of Medical Devices (UDI) system in Brazil. This system, provided for in RDC 591/2021, obliges manufacturers and legal representatives to register the UDI-DI code in the system, ensuring greater traceability and transparency in the Brazilian market. Separate submissions are required per model, with mandatory fields such as GMDN codes and technical data for the device.

Australia's TGA has published a new version of its regulatory guidance for IVD companion diagnostics (CDx), with a direct impact on medical device manufacturers and sponsors of drugs and biologics. The document describes the legal framework, clinical and analytical assessment criteria, classification, ARTG submission requirements and the use of in-house developed CDx.

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 coordinated assessment pilot project for clinical investigations and performance studies aims to harmonize the regulatory process for medical devices in the European Union. Based on Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), this pilot promotes transparency and efficiency, reducing the administrative burden and speeding up regulatory approval.

The MDCG scientific opinion on SARS-CoV-2 assesses the impact on the classification of IVD devices in accordance with Regulation (EU) 2017/746. The reassessment considers the evolution of the pandemic and the current epidemiological scenario, analysing transmissibility and life risk in the general population and in risk groups. This opinion is crucial for the medical device industry, especially to ensure regulatory compliance.