MDCG 2021-12 Rev.1 FAQ provides a detailed explanation of the European Medical Device Nomenclature (EMDN), which is an essential resource for ensuring the compliance of medical devices and IVDs in the context of the European Union's MDR and IVDR regulations. With the January 2025 revision, this document guides manufacturers on how to correctly assign EMDN codes to their devices in EUDAMED. In addition, it clarifies aspects of the hierarchical structure of the nomenclature, the use of alphanumeric codes, and the annual nomenclature update process.

MDCG 2024-2 Rev.1 ushers in a new era for the European Medical Device Nomenclature (EMDN), establishing dynamic procedures that ensure innovation, safety, and efficiency in the medical device sector. This revision, aligned with the MDR and IVDR regulations, introduces annual updates and ad-hoc requests to meet rapid technological changes and growing market demands. With a focus on collaboration between stakeholders, the update reinforces trust between manufacturers, healthcare professionals and patients, ensuring that device classification is accurate, relevant and safe.

Cybersecurity in hospitals has become a key priority with the increasing digitisation of healthcare services, including electronic health records, telemedicine and AI-based diagnostics. The European Union has launched the European Action Plan for Cybersecurity of Hospitals and Healthcare Providers, focusing on preventing cyber attacks, detecting threats, and improving response and recovery to minimise the impact of incidents such as ransomware. This plan includes measures such as the creation of a European Cybersecurity Support Centre, annual cyber maturity assessments, and training for healthcare professionals, ensuring a secure and innovative future for healthcare across the EU.

Artificial Intelligence (AI) is transforming the healthcare sector, presenting itself as an essential tool for achieving global equity, improving operational efficiency, and driving innovation in healthcare. According to the World Economic Forum report, The Future of AI-Enabled Health: Leading the Way, the adoption of AI solutions requires addressing challenges related to fragmented governance, lack of strategic alignment, and the need for effective public-private partnerships. This document also highlights six key transitions to ensure that AI reaches its full potential in the digital transformation of healthcare, promoting a smarter and healthier future.

Implementing Regulation (EU) 2025/117 introduces detailed rules for joint scientific consultations under the HTA Regulation, promoting collaboration between medical device and IVD developers, clinical experts, patients, and stakeholders. This new regulatory framework, in force since January 2025, reinforces technological innovation by providing clear guidance on clinical evidence requirements, facilitating the joint clinical assessment process. Collaboration with the European Medicines Agency (EMA) is another highlight, ensuring synchronised consultations with expert panel reviews. This regulation represents an important step towards improving regulatory compliance and supporting the introduction of innovative health technologies into the European Union market.

The European Commission has released the updated list of National Contact Points for the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This essential resource supports compliance for manufacturers, distributors, and stakeholders in the medical device industry. The document includes key updates, such as revised details for Estonia's State Agency of Medicines. Stay informed about the MDR/IVDR landscape, ensure regulatory compliance, and access direct communication with EU competent authorities. Download the latest MDR and IVDR contact points document to stay ahead in the medical device and diagnostic regulation industry.

The recent study on the EU HTA Regulation for Digital Medical Devices (DMDs), including Artificial Intelligence-based technologies, highlights the need for adaptive assessment and European harmonisation to ensure market access and effective reimbursement. The study explores challenges and opportunities in the sector, such as the lack of focus on AI and the difficulties of adapting to the short life cycles of DMDs, but also points to improvements through the incorporation of real-world evidence. It highlights the importance of regulatory transparency and fast-track access routes, with innovative examples such as DiGA in Germany and PECAN in France. The harmonisation of assessment methodologies in the European Union is essential to foster innovation and competitiveness in the digital medical device sector.

The revised Preliminary Assessment Review (PAR) templates under the MDR (Regulation (EU) 2017/745) bring critical updates for Notified Bodies and the medical device industry. Published by the Medical Device Coordination Group (MDCG) in January 2025, the revisions focus on simplifying regulatory processes, including the removal of redundant sections and enhancing annexes for detailed guidance. These updates are essential for companies aiming for regulatory compliance, CE marking, and alignment with European medical device regulations.

The FDA draft guidance for Artificial Intelligence-Enabled Device Software Functions (AI-DSFs) offers comprehensive recommendations to manufacturers on lifecycle management, transparency, and bias mitigation. Emphasizing a Total Product Life Cycle (TPLC) approach, the guidance ensures AI-enabled devices meet regulatory standards, maintain safety, and address the needs of diverse patient demographics, including race, ethnicity, sex, and age. By adopting FDA-recognized consensus standards and implementing strategies to manage AI-related risks, manufacturers can enhance the quality and effectiveness of their devices. Early engagement with the FDA for combination products that integrate AI-DSFs is encouraged, fostering compliance and innovation in medical device development.

The FDA's updated guidance emphasizes the importance of including sex- and gender-specific data in medical device clinical studies, urging manufacturers to address differences in device performance and safety related to these factors. By considering variables like age, race, and ethnicity, the guidance promotes inclusivity and ensures studies reflect real-world patient demographics. Sponsors are encouraged to integrate these practices alongside device-specific recommendations to enhance reliability, regulatory compliance, and healthcare equity. This approach aligns with the FDA's commitment to improving outcomes for diverse populations through comprehensive and inclusive clinical evaluations.

MDCG 2024-8 Revision 1 brings crucial updates for IVDR compliance, including streamlined processes for conformity assessment and updated guidelines for notified bodies. Stay informed about regulatory changes in in vitro diagnostic devices under Regulation (EU) 2017/746. Learn how Smart MDR can support your business with expert guidance on IVDR conformity, ensuring compliance with EU medical device regulations. From quality management systems to technical documentation, we help you navigate the complexities of regulatory frameworks with confidence.

The revised MDCG 2023-3 Rev2 guidance addresses key aspects of vigilance reporting under the EU Medical Device Regulation (MDR) 2017/745. It offers detailed definitions of critical terms, such as serious incidents, field safety corrective actions, and adverse events, while emphasizing the importance of timely reporting by manufacturers, authorized representatives, and other stakeholders. By clarifying roles and responsibilities across the medical device lifecycle, the updated guidance ensures compliance with stringent safety standards. Manufacturers and distributors can enhance device safety, minimize patient risks, and streamline their regulatory processes by adhering to these recommendations.

The FDA's updated guidance on Section 506J of the FD&C Act, introduced by the CARES Act, provides crucial information for manufacturers of medical devices. This guidance outlines mandatory notifications for production interruptions or permanent discontinuations that could disrupt the supply of essential devices during a public health emergency. It clarifies which medical devices fall under these requirements, the appropriate timing and format for notifications, and additional voluntary details to assist the FDA in mitigating shortages. By strengthening safeguards in the medical device supply chain, the FDA aims to ensure consistent availability of critical devices, reinforcing the importance of proactive communication from manufacturers to support public health.

The FDA’s draft guidance on pulse oximeters provides critical recommendations for non-clinical and clinical performance testing, addressing concerns about factors such as skin pigmentation and oxygen saturation levels. The guidance emphasizes the importance of accurate evaluations to ensure reliable results in diverse conditions. Manufacturers are advised to follow FDA-recognized consensus standards and integrate these recommendations into premarket submissions for regulatory compliance. Additionally, the guidance highlights transparent labeling practices, informing users of potential limitations, such as inaccuracy due to poor circulation or pigmentation. This comprehensive approach ensures that both healthcare providers and patients can trust pulse oximeter data for critical health decisions.

The FDA's latest guidance on artificial intelligence (AI) models in regulatory decision-making for drug development introduces a risk-based credibility assessment framework to ensure the reliability of AI outputs. This framework tailors oversight levels, performance criteria, and risk mitigation strategies to the AI model's context of use (COU) and associated risks. Sponsors are encouraged to engage early with the FDA to align their AI applications with regulatory expectations, focusing on safety, effectiveness, and quality. While the guidance excludes AI applications in drug discovery and operational efficiencies not impacting patient safety, it highlights the importance of detailed documentation and planning for credible AI model deployment in regulatory processes.

Smart MDR launches an exclusive campaign for startups and SMEs entering the European medical device market, offering critical regulatory support. Benefit from a 10% discount on CE marking, ensuring your devices comply with EU MDR regulations, and enjoy 6 months of free PRRC services, meeting the Person Responsible for Regulatory Compliance requirement. This campaign simplifies the path to European market access, providing specialized support for medical devices, IVD, and SaMD. With over 20 years of regulatory experience, Smart MDR’s expert team, led by Sandra Balseiro, guides you through the complexities of compliance. This limited-time offer, available until January 31st, is a unique chance to ensure your device's compliance while saving costs. Schedule your meeting today and advance confidently into the European market!

The European Union's second draft of the General-Purpose AI Code of Practice is a pivotal framework for AI providers aiming to achieve compliance with the AI Act, effective August 2, 2025. Building on feedback from over 1,000 stakeholders, this draft outlines best practices for managing the entire AI lifecycle, from development to deployment and monitoring. Key principles such as ethics, transparency, and accountability are emphasized to foster public trust in AI technologies while addressing compliance challenges. Stakeholders are invited to provide input on the draft by January 15, 2025, as the EU works toward finalizing a balanced framework that supports AI innovation and safeguards societal values.

The revised MDCG 2022-3 Rev.1 guidance introduces significant updates to the verification process for Class D in vitro diagnostic devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR). Published in December 2024, this document outlines a more structured approach to batch verification by Notified Bodies, ensuring high-risk diagnostic devices meet stringent safety and performance standards. By improving compliance measures and requiring enhanced documentation, the guidance streamlines market access while maintaining rigorous oversight. These updates aim to facilitate the introduction of safer, high-quality diagnostic tools, enhancing patient safety and strengthening the healthcare ecosystem. Manufacturers are encouraged to align with these new requirements for faster and safer market entry.

The newly released Team-NB Consensus Document on the EU MDR certification process is a crucial resource for manufacturers navigating the Medical Device Regulation (EU) 2017/745. Published on December 18, 2024, this guide outlines the critical steps of the certification journey, including device classification, technical documentation preparation, and conformity assessments. It provides practical strategies for manufacturers transitioning legacy devices or certifying new products, ensuring compliance with MDR requirements. The document also highlights the importance of ongoing audits and surveillance to maintain regulatory standards. By simplifying processes and promoting consistency, the initiative fosters faster time-to-market, enhances regulatory adherence, and strengthens patient safety across the EU medical device industry.

The FDA's updated guidance for the Global Unique Device Identification Database (GUDID) introduces essential changes for medical device manufacturers. Released on December 17, 2024, this revised guidance replaces the 2014 version, focusing on compliance with UDI regulations and enhancing the submission process. Key updates include the shift to GMDN codes as the standard for device identification, ensuring global harmonization and simplifying classification and registration. Additional improvements feature enhanced validation rules and a streamlined user interface for GUDID submissions, minimizing errors and optimizing workflows. This guidance strengthens the system for device tracking, crucial for regulatory compliance and global market access strategies. Staying aligned with these changes is critical for manufacturers to ensure seamless operations and maintain a competitive edge.