Main changes introduced by the new MIR form
The European Competent Authorities and Industry representative organisations agreed to use codified information on incidents (adverse events in IMDRF terminology) for the reporting of incidents in advance of the date of application of the upcoming Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices (EU) (‘MDR’) and Regulation (EU) 2017/746
1. New adverse event terminologies to be implemented in the European incident reporting system During the past number of years, the International Medical Device Regulators Forum (IMDRF) (http://www.imdrf.org/) has developed and published new terms and codes for adverse event reporting. It is anticipated that this internationally harmonised terminology will improve stakeholders ability to conduct detection, description, analysis of and information exchanges relating to risks and failures associated with medical devices an in vitro diagnostic medical devices, enabling faster responses by industry and authorities. Notably, the word ‘adverse event’ in the present context includes (serious) incident as defined in the EU (MDR art 2. definition 65, IVDR art 2. definition 68).
The IMDRF adverse event terminologies are scheduled to be implemented in the European vigilance reporting system with a one-year transition period after their initial publication on IMDRF website where they are publicly available at the following link: http://www.imdrf.org/documents/documents.asp
Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form