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.

Implementing Decision (EU) 2025/681 introduces six new harmonized standards under the Medical Devices Regulation (MDR), directly impacting manufacturers of single-use medical gloves, sterile devices and ambulance patient transport equipment. Compliance with these standards allows presumption of conformity with the essential requirements of the MDR, facilitating CE marking and access to the European market. Smart MDR supports manufacturers in reviewing technical documentation, assessing regulatory impact and adapting processes to the new European legislation.

Anvisa has opened Public Consultation No. 1,313/2025 to receive suggestions on the Normative Instruction that regulates the transmission and management of the UDI Brasil database, as provided for in RDC No. 591/2021. The regulation will detail the technical and operational criteria for data transmission, making it essential for companies in the sector to be prepared for the future obligation.

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.

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.

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.