Medical Device Primary Identity Information The value of the data elements are assigned by Medical Device Name the Regulated Entity for the purposes of or Common name) identifying and tracking the medical device throughout its life cycle. Catalog/Reference (REF) Catalog/Reference (REF) Description Version (Software or Firmware) Unique Device Identifier (UDI) Device Identifier (DI) Production Identifier (PI) Serial Number Lot or Batch Number Manufacturing Date Expiration Date Regulated Entity These data elements as specified by the Name Regulatory Authority and the values provided Address by the Regulated Entity are for the purposes Identifier of identifying the legal party involved in a Type regulatory activity. Kit These data elements provide an indicator used to differentiate the grouping of different Medical Device System medical devices and/or accessories for the purpose of placing it on the market. Contains Biological Materials This data element provides an indicator for the existence of specific biologic materials in the medical device for safety purposes. Medical Device The values of the data elements are Single Use Device determined by the Regulated Entity for the Reusable - Single Patient Use Device purposes of managing risks associated with Reusable - Multi-Patient Use Device multiple use of the medical device. Sterilization Information The values of the data elements are Supplied Sterile determined by the Regulated Entity for the Needs Sterilization before use purposes of managing risks associated with Method of Sterilization sterilization. Regulatory Information The values of the data elements are assigned Medical Device Type by the Regulatory Authority for the purposes Medical Device Risk Classification of identifying and tracking regulatory Submission Number activities for a medical device through its life Regulatory Authorization or Marketing cycle. Number Regulatory Authorization or Marketing Status Note: The values assigned to the data elements may change at any point in time and may require reporting to the Regulatory Authority.
Medical Device Primary Identity Information Medical Device Name or Common name) Catalog/Reference (REF) Catalog/Reference (REF) Description Version (Software or Firmware) Unique Device Identifier (UDI) Device Identifier (DI) Production Identifier (PI) Serial Number Lot or Batch Number Manufacturing Date Expiration Date The value of the data elements are assigned by the Regulated Entity for the purposes of identifying and tracking the medical device throughout its life cycle. Regulated Entity Name Address Identifier Type These data elements as specified by the Regulatory Authority and the values provided by the Regulated Entity are for the purposes of identifying the legal party involved in a regulatory activity. Kit These data elements provide an indicator used to differentiate the grouping of different medical devices and/or accessories for the purpose of placing it on the market. Medical Device System Contains Biological Materials This data element provides an indicator for the existence of specific biologic materials in the medical device for safety purposes. Medical Device Single Use Device Reusable - Single Patient Use Device Reusable - Multi-Patient Use Device The values of the data elements are determined by the Regulated Entity for the purposes of managing risks associated with multiple use of the medical device. Sterilization Information Supplied Sterile Needs Sterilization before use Method of Sterilization The values of the data elements are determined by the Regulated Entity for the purposes of managing risks associated with sterilization. Regulatory Information Medical Device Type Medical Device Risk Classification Submission Number Regulatory Authorization or Marketing Number Regulatory Authorization or Marketing Status The values of the data elements are assigned by the Regulatory Authority for the purposes of identifying and tracking regulatory activities for a medical device through its life cycle. Note: The values assigned to the data elements may change at any point in time and may require reporting to the Regulatory Authority.
imdrf-tech-rps-common-data-elements.docx