# Manufacturer Incident Report (MIR) - Changelog

## Version 7.2.1 (XX/05/2019)

### Fixed
1.2 b: Date of incident mandatory in the XSD files. In the PDF it was already implemented.
2.4 a: The string "OR MDR/IVDR" is removed from deviceClassT element in the XSD files. In the PDF it was already correct.
3.2 a: Choice 1 mandatory in the XSD files. In the PDF it was already implemented.

The form was not blocked when sent via email. Fixed.

### Changed
4.2 f: IMDRF Component codes (Annex G) accepts 8 characters codes according to the format published in April 2020
4.4.3 c: Limitation to 1,000,000 for Number of devices on market has been removed

The following fields has been made auto-expandable:
2.6 a - Relevant accessories used with the device being reported on
2.6 b - Relevant associated devices used with the device being reported on
3.1 a - Provide a comprehensive description of the incident
3.2 f - Remedial actions taken by healthcare facility, patient or user subsequent to the incident
3.3 a - If you think the incident is unique and a suitable IMDRF term is missing, briefly explain
3.2 a - If you think the incident is unique and a suitable IMDRF term is missing, briefly explain
3.3 e - List any of the patient's prior health condition or medication that may be relevant to this incident
4.1 a - For initial and follow-up reports: preliminary results and conclusions of manufacturer’s investigation
4.1 b - Initial actions (corrective and/or preventive) implemented by the manufacturer
4.1 c - What further investigations do you intend in view of reaching final conclusions?
4.2 a - Description of the manufacturer’s evaluation concerning possible root causes/causative factors and conclusion
4.2 b - Fill out rationale for why this is considered not reportable
4.2 d - Rationale for no review
4.2 d - Results of the assessment:
4.2 e - If you think the incident is unique and a suitable IMDRF term is missing, briefly explain
4.2 f - If you think the incident is unique and a suitable IMDRF term is missing, briefly explain:
4.2 g - Description of remedial action/corrective action/preventive action/field safety corrective action (FSCA)
4.2 h - Time schedule for the implementation of the identified actions
4.2 i - Final comments from the manufacturer on cause investigation and conclusion
4.3.1 - Other
4.3.2 - Other
4.3.3 a - Details of the selection made above
4.3.3 b - Other describe
4.3.3 d - Comments on how similar incidents and associated number of devices on the market were determined
5 - General comments



## Version 7.2 (02/09/2019)

### Added
2.2 a: Radio button for EMDN. This change will require also a little modification of the XML. The XSDs files have been modified accordingly: a new enumeration element with value "EMDN" has been added to the simpleType "nomenclatureSystemT".

### Changed
1.1 c: mandatory for Follow up, Final Reportable and Final Non reportable. Both the PDF from and the XSDs have been modified.
2.1 a: label changed from "UDI device identifier" to "UDI device identifier/Eudamed ID". The HelpText has been modified accordingly.
2.1 c: label changed from "Basic UDI-DI" to "Basic UDI-DI/Eudamed-DI". The HelpText has been modified accordingly.
4.3.3 c: XSDs files have been modified (complex type numSimilarIncidentsDevicesT) in order to be compatible with stylesheet-based mapping techniques (e.g. Lotus Note)

### Fixed
3.3 b: The code that validates the content of years, months and days has been modified in order to be aligned with the Helptext.

Mismatch between mandatory rule and filed data type (i.e. nonEmptyString50T, nonEmptyString200T) for the following fields:
1.3.1 a: reporterOtherText
1.3.1 b: mfrRef 
1.3.4 g: reporterOrgStreet
1.3.4 h: reporterOrgStreetNum
1.3.4 i: reporterOrgAddress
1.3.2 b: mfrSRN
1.3.2 h: mfrOrgStreet
1.3.2 i: mfrOrgStreetNum
1.3.2 j: mfrAddress
1.3.3 b: ARSRN
1.3.3 c: ARContactPersonFirstName
1.3.3 d: ARContactPersonSecondName
1.3.3 h: ARStreet
1.3.3 i: ARStreetNum
1.3.3 j: ARAddress
1.3.3 l: ARCity
1.3.3 m: ARPostCode
1.3.3 f: ARPhone
4.2 i: manufacturersFinalComments

## Version 7.1 (09/01/2019)

### Fixed 
The title of the form has been modified from "Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)" to "Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/AIMDD/IVDD)"