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.

The new EUDAMED user guide for Unique Identifier (UDI) devices is an indispensable reference for all medical device manufacturers who want to ensure compliance with the MDR and IVDR regulations. The document covers aspects such as registering Basic UDI-DI and UDI-DI, managing data in EUDAMED, connecting to legacy devices, and updating versions. It also includes crucial information on requirements for accessing the EUDAMED platform, user profiles, and the procedures for structured data submission. This guide is essential for ensuring an effective compliance strategy in the European regulatory context.

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.

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 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.