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.

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.

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.

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.