The Manufacturer Incident Report (MIR) form was created by the European Commission. It is a standardized way for manufacturers to notify the relevant competent authorities of serious incidents that occurred in Europe.
The transition from the MDD (Medical Device Directive) to the MDR (Medical Device Regulation) has brought about a significant increase in the information requirements that must be provided together with medical devices.
IMDRF Adverse Event Report (AER) terms and codes are standardized terminology used to classify and report adverse events related to medical devices. Agencies such as the European Notified Bodies and Competent Authorities, UK MHRA, Australian TGA, and US FDA use IMDRF AER codes, and their use helps ensure consistent reporting across different regulatory jurisdictions.
Industry may submit requests to amend or add new EMDN codes, as needed. For an overview of the process and timing to do so, please read: How do I request a new EMDN code?
MDCG 2019-6 (Q&A on Requirements related to Notified Bodies) has been revised. Revision 5* is available: HERE
The MHRA published the new Post-Market Surveillance (PMS) regulation (SI 2024/1368) in December: HERE
The new PMS regulation introduces changes such as:
High-level: legacy devices are those that held valid CE marking under the old EU Directives (MDD/AIMDD/IVDD) on the day the MDR/IVDR went into effect and met the specified conditions. These are eligible for a longer transition period to CE Mark under the MDR/IVDR.
