The new FDA guidance proposes improvements in the labeling of surgical hernia mesh, with the aim of reducing adverse events and facilitating device selection by healthcare professionals. Among the recommended data are mesh composition, physical characteristics and mechanical properties. The initiative applies to devices specifically indicated for hernia repair and encourages manufacturers to update the labeling in their submissions to the FDA.

The FDA's new M11 technical specification, developed within the framework of ICH, defines a structured and harmonized electronic template for clinical protocols - CeSHarP. This document promotes the international standardization of clinical trial documentation, facilitating electronic submission and regulatory interoperability between agencies such as the FDA, EMA and PMDA.

The FDA has published a new draft guidance on the transfer of 510(k) clearances, focusing on situations that do not require a new submission but do require compliance with registration, device listing and labeling update requirements. The document clarifies that the new holder must register in the FURLS/DRLM system, ensure that the 510(k) number is correctly associated with their name, and comply with UDI requirements.

Version 7.3.1 of the MIR form, published by the European Commission on June 4, 2025, introduces new requirements for reporting serious incidents involving medical devices and IVDs.

A atualização da EUDAMED versão 2.15.0 introduz melhorias relevantes para o registo de dispositivos médicos e IVD, incluindo a gestão de UDI-DI, funcionalidades para Master UDI-DI em lentes de contacto, e novas opções de pesquisa no portal público. Esta versão corrige mais de 50 erros reportados pelos utilizadores, reforçando a fiabilidade da base de dados europeia de dispositivos médicos. Para os fabricantes, mandatários e importadores, é essencial rever os dados submetidos e preparar os processos internos para assegurar a conformidade com o MDR e IVDR.

The FDA has published a draft guidance establishing the mandatory use of the eSTAR electronic template for all Q-Submissions, including Pre-Submissions, within the scope of medical device regulation. This proposal aims to improve the quality, consistency and traceability of submissions made to the FDA, progressively replacing free formats with a structured, digital template.

The FDA 's new guidance on the Q-Submission Program offers practical guidelines for manufacturers who intend to request formal feedback or technical meetings during the planning or review of regulatory submissions for medical devices and IVDs.

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.

MedTech Europe 's new practical guide to the European Medical Device Nomenclature (EMDN) provides key guidance for medical device manufacturers and IVDs. The correct assignment of EMDN codes is mandatory for registering devices with EUDAMED and for demonstrating compliance with the MDR and IVDR.

The FDA 's recent decision to expand the use of unannounced inspections at manufacturing facilities outside the United States has relevant implications for medical device and drug manufacturers exporting to the US market. This approach requires manufacturers to maintain robust quality systems, permanently updated documentation and a culture of continuous compliance.

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.

The European Union's AI Act establishes new legal obligations for all organizations that develop or use artificial intelligence systems. Article 4 of the AI Act, applicable since February 2, 2025, requires companies to ensure an adequate level of AI literacy among their employees and service providers.

The recent completion of the FDA's artificial intelligence-supported pilot project marks an important step in the modernization of scientific review processes. With the promise of speeding up evaluations and reducing repetitive tasks, the FDA plans to implement generative AI across the board by June 2025.

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 new version of Swissmedic's guidance on GMP compliance verification of foreign manufacturers applies to all marketing authorization (MA) holders and their Responsible Persons (RP) in Switzerland.

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.

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.