On 5 May 2025, Version 7.3.1 of the European form for reporting serious incidents (Manufacturer Incident Report, MIR) was published by the European Commission. This new version replaces the previous edition 7.2.1 and includes a number of technical, formal and content-related changes that directly affect manufacturers and their Person Responsible for Regulatory Compliance (PRRC). BEO BERLIN provides an overview of the changes and their significance for manufacturers – with pragmatism, partnership and professionalism.
MIR now Available for Reporting to Swissmedic
The new MIR form 7.3.1 has already been approved for submissions to Swissmedic and will soon also be available in Germany via the BfArM in Germany. We therefore recommend switching to the new format now to avoid media breaks and unnecessary queries. As an EU and CH representative and in our role as PRRC, BEO BERLIN is regularly involved in the notification process and supports manufacturers in ensuring compliant implementation.
What has been Changed?
Version 7.3.1 not only refines the structure of the MIR form, but also increases the depth of the information provided. The most notable change is the expansion of the mandatory fields in sections 2.2, 4.3.1 and 4.3.2: information on device typing and the identification of similar (serious) incidents must now be provided. These changes promote comparability and data quality, but also require more intensive preliminary checks and clearly documented reporting routines. In addition, the technical validation logic has been further developed. The new form is supplemented by the updated European guidance document MDCG 2023-3 Rev. 2. This provides specific guidance on key terms such as ‘serious incident’, ‘indirect damage’ and ‘expected erroneous results’ and explains the new field ‘Manufacturer awareness date of reportability’. For manufacturers, this not only provides greater legal clarity, but also necessitates a careful alignment of internal reporting processes and responsibilities. BEO BERLIN recommends integrating the changes into existing processes at an early stage.
BEO BERLIN as your Reliable Partner
BEO BERLIN continues to support manufacturers with its expertise and experience – whether as an EU or CH representative, as a Person Responsible for Regulatory Compliance (PRRC) or within the scope of targeted individual services. We guide you through the hurdles of the new MIR form, assist with coding for the International Medical Device Regulators Forum (IMDRF) and ensure consistent and plausible reporting to authorities. Get in touch with us – we'll take care of it. With pragmatism, partnership and professionalism.
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