# MHRA MIR Generation Data Mapping Learn how Vault maps _Case_ details to generate Manufacturer Incident Reports (MIRs) for reporting to the Medicines and Healthcare products Regulatory Agency (MHRA). Vault formats the document as an XML that uses the schema definitions (XSD) for Great Britain for the Manufacturer's Online Reporting Environment (MORE) reporting system and conforms to the GB MIR 7.2.1 schema. ## Section 1: Administrative information Section 1 captures information about the corresponding competent authority, the incident report, and the report submitter. ### 1.1 Corresponding competent authority The form data elements include:

MHRA MIR Data Element	Data Source
a. Name of receiving national competent authority (NCA)	The Name of the Agency in the Destination field of the Transmission.
b. EUDAMED number of NCA	The EUDAMED Number of the Agency in the Destination field of the Transmission.
c. Reference number assigned by NCA for this incident	The NCA Reference Number on the Device Incident Report of the Device-type Case Product. If blank, Vault populates `Not Known`.
d. Reference number assigned by EUDAMED for this incident	The EUDAMED Reference Number on the Device Incident Report of the Device-type Case Product. If blank, Vault populates `Not Known`.

### 1.2 Date, type, and classification of incident report The form data elements include:

MHRA MIR Data Element	Data Source
a. Date of submission	The Transmission Date on the Transmission.
b. Date of incident	The Onset and Cessation dates of the primary Case Adverse Event. If only a partial date exists, Vault populates `01` for the missing month and day as needed. For example, if the Onset date includes only the year `2025`, Vault populates `2025-01-01`. If both fields are blank, Vault populates the first box based on the current year and the second box based on the Transmission Date. For example, for a Transmission in 2025, Vault populates `2025-01-01` for the Onset date.
c. Manufacturer awareness date	The Initial Receipt Date on the Case.
d. Type of report	The Type of Incident Report on the Device Incident Report of the Device-type Case Product.
e. In case of initial and follow-up reports, please indicate the expected date of the next report	The Expected Date of Next Report on the Device Incident Report of the Device-type Case Product.
f. Classification of incident	Vault exports an option using the following priority: Death: If the Seriousness of the Case Adverse Event includes Results in Death Serious public health threat: If the Device Report Type of the Device-type Case Product includes Public Health Risk Unanticipated serious deterioration in state of health: If the Device Report Type of the Device-type Case Product does not include Public Health Risk and the Case Adverse Event includes a value All other reportable incidents: In all other scenarios

### 1.3 Submitter information The XML includes the following sections. #### 1.3.1 Submitter of the report The form data elements include:

MHRA MIR Data Element	Data Source
a. Submitter of the report	The Submitter of Report on the Device Incident Report of the Device-type Case Product. When the Submitter of Report is Other, Vault also exports the Submitter of Report (Other) text.
b. Manufacturer's reference number for this incident	The Manufacturer Reference Number on the Device Incident Report of the Device-type Case Product.
c. NCA's local reference number	If any Case Products include an NCA Reference Number, Vault exports the value. Vault comma-separates multiple values.
c. EUDAMED's reference number	If any Case Products include a EUDAMED Number, Vault exports the value. Vault comma-separates multiple values.
c. Manufacturer's reference number	If any Case Products include a Manufacturer Reference Number, Vault exports the value. Vault comma-separates multiple values.
d. NCA's local FSCA reference number	The NCA FSCA Reference Number on the Device Incident Report of the Device-type Case Product.
d. EUDAMED's FSCA reference number	The EUDAMED FSCA Reference Number on the Device Incident Report of the Device-type Case Product.
d. Manufacturer's FSCA reference number	The Manufacturer FSCA Reference Number on the Device Incident Report of the Device-type Case Product.
e. Periodic Summary Report (PSR) ID	Vault does not populate this data element.
f. If the incident occurred within a PMCF/PMPF investigation; please provide the Eudamed ID of that PMCF/PMPF investigation	For study Cases with a Study Type of Other and a Registration Type that corresponds to E2B code `7`, Vault exports the Registration Number on the Case Study Registration.

#### 1.3.2 Manufacturer information The form data elements include:

MHRA MIR Data Element	Data Source
a. Manufacturer organisation name	The Name of the Organization linked in the Manufacturer field of the corresponding Product record.
b. Single registration number	The Single Registration Number (SRN) of the Organization linked in the Manufacturer field of the corresponding Product record.
c. Contact's first name	The First Name of the User associated with the Sender (User) on the Transmission.
d. Contact's last name	The Last Name of the User associated with the Sender (User) on the Transmission.
e. Email	The Email of the User associated with the Sender (User) on the Transmission.
f. Phone	The value in the Telephone field of the User associated with the Sender (User) on the Transmission.
g. Country	The two-letter ISO code associated with the Country of the User associated with the Sender (User) on the Transmission.
h. Street	The value, excluding leading numbers, in the Street field of the User associated with the Sender (User) on the Transmission. Vault does not populate this data element if the street address includes a PO Box.
i. Street number	The leading numbers in the Street field of the User associated with the Sender (User) on the Transmission.
j. Address complement	Vault does not populate this data element.
k. PO Box	If the Street field of the User associated with the Sender (User) on the Transmission includes a PO Box, Vault populates the Street value.
l. City name	The City of the User associated with the Sender (User) on the Transmission.
m. Postal code	The Postal Code of the User associated with the Sender (User) on the Transmission.

#### 1.3.3 Authorized representative information/United Kingdom Responsible Person Vault populates this section only if the _Submitter of Report_ is _Authorised Representative_ or _United Kingdom Responsible Person_. The form data elements include:

MHRA MIR Data Element	Data Source
a. Authorised representative/United Kingdom Responsible Person Organisation name	The Name of the Organization associated with the Sender (User) on the Transmission.
b. Single Registration Number	The Single Registration Number (SRN) of the Organization associated with the Sender (User) on the Transmission.
c. Contact's first name	The First Name of the User associated with the Sender (User) on the Transmission.
d. Contact's last name	The Last Name of the User associated with the Sender (User) on the Transmission.
e. Email	The Email of the User associated with the Sender (User) on the Transmission.
f. Phone	The value in the Telephone field of the User associated with the Sender (User) on the Transmission.
g. Country	The two-letter ISO code associated with the Country of the User associated with the Sender (User) on the Transmission.
h. Street	The value, excluding leading numbers, in the Street field of the User associated with the Sender (User) on the Transmission. Vault does not populate this data element if the street address includes a PO Box.
i. Street number	The leading numbers in the Street field of the User associated with the Sender (User) on the Transmission.
j. Address complement	Vault does not populate this data element.
k. PO Box	If the Street field of the User associated with the Sender (User) on the Transmission includes a PO Box, Vault populates the Street value.
l. City name	The City of the User associated with the Sender (User) on the Transmission.
m. Postal code	The Postal Code of the User associated with the Sender (User) on the Transmission.

#### 1.3.4 Submitter's details if not also manufacturer, authorised representative, or United Kingdom Responsible Person Vault populates this section only if the _Submitter of Report_ is _Other_. The form data elements include:

MHRA MIR Data Element	Data Source
a. Registered commercial name of company	The Name of the Organization associated with the Sender (User) on the Transmission.
b. Contact's first name	The First Name of the User associated with the Sender (User) on the Transmission.
c. Contact's last name	The Last Name of the User associated with the Sender (User) on the Transmission.
d. Email	The Email of the User associated with the Sender (User) on the Transmission.
e. Phone	The value in the Telephone field of the User associated with the Sender (User) on the Transmission.
f. Country	The two-letter ISO code associated with the Country of the User associated with the Sender (User) on the Transmission.
g. Street	The value, excluding leading numbers, in the Street field of the User associated with the Sender (User) on the Transmission. Vault does not populate this data element if the street address includes a PO Box.
h. Street number	The leading numbers in the Street field of the User associated with the Sender (User) on the Transmission.
i. Address complement	Vault does not populate this data element.
j. PO Box	If the Street field of the User associated with the Sender (User) on the Transmission includes a PO Box, Vault populates the Street value.
k. City name	The City of the User associated with the Sender (User) on the Transmission.
l. Postal code	The Postal Code of the User associated with the Sender (User) on the Transmission.

## Section 2: Medical device information Section 2 includes device identification, categorization, description, and risk class information, as well as identifies the market distribution of the device and the use of relevant related accessories and devices. ### 2.1 Unique Device Identification (UDI) The form data elements include:

MHRA MIR Data Element	Data Source
a. UDI device identifier/Eudamed ID	The Unique Identifier on the Device Information record of the Device-type Case Product.
b. UDI production identifier	The UDI Production Identifier on the Device Information record of the Device-type Case Product.
c. Basic UDI-DI/Eudamed-DI	The Basic UDI-DI on the Product related to the Device-type Case Product.
d. Unit of use UDI-DI	The Unit of Use UDI-DI on the Device Information record of the Device-type Case Product.

### 2.2 Categorisation of device The form data elements include:

MHRA MIR Data Element	Data Source
a. Medical device terminology	The Medical Device Terminology on the Device Incident Report of the Device-type Case Product. Vault exports this data element only if the Medical Device Terminology is GMDN.
b. Medical device nomenclature code	The Device Nomenclature Code on the Device Information record of the Device-type Case Product. Vault exports this data element only if the Medical Device Terminology is GMDN.

### 2.3 Description of device and commercial information The form data elements include:

MHRA MIR Data Element	Data Source
a. Medical device name (brand/trade /proprietary or common name)	The Brand Name on the Product related to the Device-type Case Product.
b. Nomenclature text/Description of the device and its intended use	The Description of Device on the Product related to the Device-type Case Product.
c. Model	The Model Number on the Device Information record of the Device-type Case Product.
d. Catalogue/reference number	The Catalog Number on the Device Information record of the Device-type Case Product.
e. Serial number	The Serial Number on the Device Information record of the Device-type Case Product.
f. Lot/batch number	Vault populates a value using the following priority: The Batch/Lot Number of the Case Product Dosage The Lot Number in the Device Information section of the Device-type Case Product
g. Software version	The Software Version on the Device Information record of the Device-type Case Product.
h. Firmware version	The Firmware Version on the Device Information record of the Device-type Case Product.
i. Device manufacturing date	The Manufacture Date on the Device Information record of the Device-type Case Product.
j. Device expiry date	The Expiration Date on the Device-type Case Product.
k. Date when device was implanted	The Date Implanted on the Device Information record of the Device-type Case Product. If only a partial date exists, Vault populates `01` for the missing month and day as needed. For example, if the Onset date includes only the year `2025`, Vault populates `2025-01-01`.
l. Date when device was explanted	The Date Explanted on the Device Information record of the Device-type Case Product. If only a partial date exists, Vault populates `01` for the missing month and day as needed. For example, if the Onset date includes only the year `2025`, Vault populates `2025-01-01`.
m. If precise implant/explant dates are unknown, provide the duration of implantation	If both the Date Implanted and Date Explanted are available and include exact dates, Vault populates the date range of implantation. Vault does not export partial dates.
n. Implant facility	The Implant Facility on the Device Information record of the Device-type Case Product.
o. Explant facility	The Explant Facility on the Device Information record of the Device-type Case Product.
p. Notified body (NB) ID number(s) Notified body (NB) certificate number(s) of device	The Notified Body ID and Notified Body Certificate Number on the United Kingdom Product Registration of the Device-type Case Product. If two applicable registrations exist, Vault exports both. If more than two exist, Vault exports the two with the earliest created dates.
q. Please indicate the date of one of the following	The Device Market Date Type and Device Market Date on the Product Registration of the Device-type Case Product.

### 2.4 Risk class of device when placed on market The form data elements include:

MHRA MIR Data Element	Data Source
a. This device has been placed on the market before the implementation of the MDD/AIMDD/IVDD	Vault exports a value if the Product Registration of the Device-type Case Product meets both criteria: The MDD/AIMDD Risk Class is Marketed Before MDD/AIMDD. The IVDD Risk Class is Marketed Before IVDD.
b. MDD/AIMDD	The MDD/AIMDD Risk Class on a Product Registration using the following priority: The MDD/AIMDD Risk Class of a Product Registration linked to the Case Product. The MDD/AIMDD Risk Class of a Product Registration in a country where the Case Adverse Event occurred. Vault exports the first found record with a value. The MDD/AIMDD Risk Class of a Product Registration in a country under the jurisdiction of the EMA. Vault exports the first found record with a value. Vault does not populate this data element when the MDD/AIMDD Risk Class is Marketed Before MDD/AIMDD.
b. IVDD	The IVDD Risk Class on a Product Registration using the following priority: The IVDD Risk Class of a Product Registration linked to the Case Product. The IVDD Risk Class of a Product Registration in a country where the Case Adverse Event occurred. Vault exports the first found record with a value. The IVDD Risk Class of a Product Registration in a country under the jurisdiction of the EMA. Vault exports the first found record with a value. Vault does not populate this data element when the IVDD Risk Class is Marketed Before IVDD.
c. MDR	The MDR Class on a Product Registration using the following priority: The MDR Class of a Product Registration linked to the Case Product. The MDR Class of a Product Registration in a country where the Case Adverse Event occurred. Vault exports the first found record with a value. The MDR Class of a Product Registration in a country under the jurisdiction of the EMA. Vault exports the first found record with a value.
c. Type	The MDR Type on a Product Registration using the following priority: The MDR Type of a Product Registration linked to the Case Product. The MDR Type of a Product Registration in a country where the Case Adverse Event occurred. Vault exports the first found record with a value. The MDR Type of a Product Registration in a country under the jurisdiction of the EMA. Vault exports the first found record with a value.
c. IVDR	The IVDR Class on a Product Registration using the following priority: The IVDR Class of a Product Registration linked to the Case Product. The IVDR Class of a Product Registration in a country where the Case Adverse Event occurred. Vault exports the first found record with a value. The IVDR Class of a Product Registration in a country under the jurisdiction of the EMA. Vault exports the first found record with a value.
c. Type	The IVDR Type on a Product Registration using the following priority: The IVDR Type of a Product Registration linked to the Case Product. The IVDR Type of a Product Registration in a country where the Case Adverse Event occurred. Vault exports the first found record with a value. The IVDR Type of a Product Registration in a country under the jurisdiction of the EMA. Vault exports the first found record with a value.

### 2.5 Market distribution of device (region/country) The form data elements include:

MHRA MIR Data Element	Data Source
a. Market distribution of device (region/country)	Vault exports each country code where the Case Product has a Product Registration.

### 2.6 Use of accessories, associated devices or other devices The form data elements include:

MHRA MIR Data Element	Data Source
a. Relevant accessories used with the device being reported on	The Relevant Accessories on the Device Information record of the Device-type Case Product.
b. Relevant associated devices used with the device being reported on	The Relevant Associated Devices on the Device Information record of the Device-type Case Product.

## Section 3: Incident information derived from healthcare professional/facility/patient/lay user/other Section 3 includes details about the nature of the incident, medical device problem, patient, and initial reporter. ### 3.1 Nature of incident The form data elements include:

MHRA MIR Data Element	Data Source
a. Provide a comprehensive description of the incident	The text from the Narrative on the Case.

### 3.2 Medical device problem information The form data elements include:

MHRA MIR Data Element	Data Source
a. IMDRF Medical device problem codes (Annex A)	If the Device Type Code of the Device-type Case Product is Medical Device Problem, Vault exports an IMDRF code using the following priority: Level 3 Level 2 Level 1
b. Number of patients involved	Vault populates `1`.
c. What is the current location of the device?	The Current Device Location on the Device Information record of the Device-type Case Product. When the Current Device Location is Other, Vault also exports the Current Device Location (Other) text.
d. Operator of device at the time of the incident	The Operator of Device on the Device Information record of the Device-type Case Product. When the Operator of Device is Other, Vault also exports the Operator of Device (Other) text.
e. Usage of device (as intended)	The Device Usage Type value and the Usage of Device (Other) text on the Device Information record of the Device-type Case Product.
f. Remedial actions taken by healthcare facility, patient or user subsequent to the incident	The Remedial Action and Remedial Action (Other) values from the Case Product. Vault comma-separates multiple values.

### 3.3 Patient information The form data elements include:

MHRA MIR Data Element	Data Source
a. IMDRF 'Health Effect' terms and codes (Annex E, F)	If the Device Type Code of the Device-type Case Product is Health Effects - Clinical signs and Symptoms or Conditions or Health Effects - Health Impact, Vault exports an IMDRF code based on the Rank field of the Case Product Device Code, if populated. Otherwise, Vault exports a code using the following priority: Level 3 Level 2 Level 1
b. Age of patient at the time of the incident	The Age (normalized) of the Case Patient. If the age value is two (2) years or less, Vault exports the age in years, months, and days. Otherwise, Vault populates only the year, rounding down to the nearest year.
c. Gender	The Sex of the Case Patient.
d. Body weight	The Weight (normalized) of the Case Patient.
e. List any of the patient's prior health condition or medication that may be relevant to this incident	The Device Usage Type value and the Usage of Device (Other) text on the Device Information record of the Device-type Case Product.
f. Remedial actions taken by healthcare facility, patient or user subsequent to the incident	Vault populates: For each Case Medical History record: Disease / Surgical Procedure (MedDRA), [Start Date or ---] to [End Date or --- or Continuing], Comments Text in the Medical History Text field on the Case For each Case Drug History record: Drug Coded Name, [Start Date or ---] to [End Date or ---], Indication MedDRA

### 3.4 Initial reporter (can be healthcare professional of facility, patient, lay user) The form data elements include:

MHRA MIR Data Element	Data Source
a. Role of initial reporter	The Qualification of the primary Reporter-type Case Contact.
b. Name of healthcare facility where incident occurred	The Facility Name or Facility Name (Reason Omitted) of the primary Reporter-type Case Contact.
c. Healthcare facility report number	Vault does not populate this data element.
d. Contact's first name	The First Name of the primary Reporter-type Case Contact.
e. Contact's last name	The Last Name of the primary Reporter-type Case Contact.
f. Email	The Email Address of the primary Reporter-type Case Contact.
g. Phone	The Telephone value of the primary Reporter-type Case Contact.
h. Country	The Country of the primary Reporter-type Case Contact.
i. Street	The Street of the primary Reporter-type Case Contact.
j. Street number	The Street Number of the primary Reporter-type Case Contact.
k. Address complement	The Street Line 2 value of the primary Reporter-type Case Contact.
l. PO Box	The PO Box of the primary Reporter-type Case Contact.
m. City name	The City of the primary Reporter-type Case Contact.
n. Postal code	The Postal Code of the primary Reporter-type Case Contact.

## Section 4: Manufacturer analysis Section 4 includes the manufacturer's preliminary comments, cause investigation and conclusion details, and similar incident information. ### 4.1 Manufacturer's preliminary comments The form data elements include:

MHRA MIR Data Element	Data Source
a. For initial and follow-up reports: preliminary results and conclusions of manufacturer's investigation	The Preliminary Results and Conclusions text on the Manufacturer Analysis of the Device-type Case Product.
b. Initial actions (corrective and/or preventive) implemented by the manufacturer	The Initial (Corrective/Preventative) Actions text on the Manufacturer Analysis of the Device-type Case Product.
c. What further investigations do you intend in view of reaching final conclusions?	The Further Investigations text on the Manufacturer Analysis of the Device-type Case Product.

### 4.2 Cause investigation and conclusion The form data elements include:

MHRA MIR Data Element	Data Source
a. For Final (Reportable incident): Description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion	The Root Cause Description and Conclusion text on the Manufacturer Analysis of the Device-type Case Product.
b. For Final (Non-reportable incident): Fill out rationale for why this is considered not reportable	The Not Reportable Rationale text on the Device Incident Report of the Device-type Case Product.
c. Is root cause confirmed?	The Is root cause confirmed? value on the Manufacturer Analysis of the Device-type Case Product.
d. Has the risk assessment been reviewed?	The Risk assessment reviewed? value on the Manufacturer Analysis of the Device-type Case Product.
d. If the risk assessment has been reviewed, is it still adequate?	The Impact and Risk Analysis text on the Manufacturer Analysis of the Device-type Case Product.
e. IMDRF 'Cause Investigation' terms and codes (Annex B, C, D)	If the Device Type Code of the Device-type Case Product is Type of Investigation, Investigation Finding, or Investigation Conclusion, Vault exports an IMDRF code using the following priority: Level 3 Level 2 Level 1
f. IMDRF Component codes (Annex G)	If the Device Type Code of the Device-type Case Product is Medical Device Component, Vault exports an IMDRF code using the following priority: Level 3 Level 2 Level 1
g. Description of remedial action/corrective action/preventive action/field safety corrective action (FSCA)	The Corrective/Preventative Action text on the Manufacturer Analysis of the Device-type Case Product.
h. Time schedule for the implementation of the identified actions	The Corrective/Preventative Action Schedule text on the Manufacturer Analysis of the Device-type Case Product.
i. Final comments from the manufacturer on cause investigation and conclusion	The Investigation Summary and Conclusion text on the Manufacturer Analysis of the Device-type Case Product.

### 4.3 Similar incidents (for Final (Reportable incident)) This includes additional information about similar incidents and the codes and terms used to identify them. #### 4.3.1 Use of IMDRF terms and codes for identifying similar incidents The form data elements include:

MHRA MIR Data Element	Data Source
a. Identification of similar incidents using IMDRF Adverse Event Reporting terms and codes	The IMDRF Similar Incident Identification on the Device Incident Report of the Device-type Case Product. When the IMDRF Similar Incident Identification is Other, Vault also exports the IMDRF Similar Incident (Other) text.

#### 4.3.2 Use of in-house terms/codes for identifying similar incidents The form data elements include:

MHRA MIR Data Element	Data Source
a. If similar incident were not identified by IMDRF codes but by in-house codes, please provide the codes and terms below.	Vault does not populate this data element.

#### 4.3.3 Number of similar incidents and devices on the market The form data elements include:

MHRA MIR Data Element	Data Source
a. Indicate on which basis similar incidents were identified regarding the device or device variant:	The Similar Incident Basis selection and the Similar Incident Basis Details text on the Device Incident Report of the Device-type Case Product.
b. Indicate to what criteria the number of devices on the market (also known as denominator data) is based on	The Devices Marketed Criteria on the Device Incident Report of the Device-type Case Product. When the Devices Marketed Criteria is Other, Vault also exports the Devices Marketed Criteria (Other) text.
c. Enter the number of similar incidents and devices on the market for the indicated time periods	For each time period and region, Vault exports the Start Date and End Date from each Case Product Similar Incident record.
d. Comments on how similar incidents and associated number of devices on the market were determined	The Similar Incident Comments text on the Device Incident Report of the Device-type Case Product.

## Section 5: General Comments Vault populates the _Company Comments_ from the _Narrative_ on the _Case_ and the _Additional Device Manufacturer Narrative_ from the _Device Information_ section of the Device-type _Case Product_.