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.

Health Canada has announced new guidance for Risk Management Plans (RMPs), reinforcing the need for pharmacovigilance and risk minimization throughout the life cycle of medicines. As of April 2027, the submission of RMPs will be mandatory in certain circumstances, such as for new drugs, biosimilars and cases of emerging risks. This update harmonizes Canadian regulations with international standards, ensuring greater safety for patients and transparency in the regulatory process. Manufacturers wishing to market products on the Canadian market must adapt to these new requirements.

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.

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 FDA and OHRP have updated the guidelines for IRB Written Procedures, aligning them with the requirements of the 21st Century Cures Act. The update aims to harmonize regulatory compliance and ensure the protection of the rights of human subjects in clinical research. It includes a Written Procedures Checklist that assists institutions and IRBs in creating comprehensive policies, promoting transparency and consistency.

Revision 5 of MDCG 2019-6 presents important updates on the requirements for Notified Bodies under the MDR and IVDR, reinforcing regulatory compliance and promoting harmonisation within the European Union. It includes clarifications on impartiality and independence, as well as specifications on consultancy, training and experience of personnel involved in conformity assessment.

The FDA has issued new recommendations to reduce the risk of sepsis transmission through human cells, tissues, and tissue-derived products (HCT/Ps). The guidelines include rigorous donor screening, evaluation of clinical and physical evidence, and diagnostic testing to identify pathogens. The goal is to ensure the safety of tissue donation and protect public health.

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.

MDCG 2025-1 introduces an ad hoc procedure form to facilitate the updating of the European Medical Device Nomenclature (EMDN). This document is crucial for manufacturers, national competent authorities (NCAs) and notified bodies (NBs) that need to register devices in the UDI-DI module of EUDAMED. The new approach allows proposals for new codes to be submitted when existing ones are insufficient, promoting the registration of innovative technologies and regulatory compliance. This initiative by the Medical Device Coordination Group (MDCG) contributes to standardisation and clarity in the medical device sector in the European Union.

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.