Team-NB, the European association of Notified Bodies, has reinforced the importance of issuing certificates with conditions under the European Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). This approach allows innovative or orphan medical devices to obtain certification under specific conditions, such as more frequent post-market assessments, restriction of use to certain population groups or marketing limited to specialized medical institutions. Team-NB encourages Notified Bodies to apply this strategy to balance innovation and patient safety, ensuring faster access to new medical technologies.

Regulation (EU) 2025/327 creates the European Health Data Space (EHDS), enabling the secure sharing of medical data and promoting digital interoperability in the European Union. The introduction of the MyHealth@EU platform will ensure the connection between national healthcare systems, making it easier for patients to access their Electronic Health Records (EHRs) and for healthcare professionals in different Member States to use them. In addition, manufacturers of medical devices and in vitro diagnostic devices (IVDs) will have to comply with new security, traceability and interoperability requirements, while digital wellness applications will need a declaration of conformity with European specifications. The first obligations will come into force from March 2027, making it essential for companies in the sector to start preparing to ensure regulatory compliance and access to the European market.

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.

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.

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.