Ennov InSight Registrations 7.3

Product Attributes

The attributes that are available for a product depend on the associated product family type.

Key for Product Family Type:

  • FV - flu vaccine
  • P - pharmaceutical
  • MD - medical device
  • PMD - pharmaceutical-medical device
  • V - veterinary
  • All - all product family types
Attribute Product Family Type Description
Alternate Product Description MD, PMD The product description for printing Certificates for Foreign Government (CFG).
Applicable Standards MD, PMD Standards (codes) to which the device adheres.
CE Date MD, PMD Date when the CE mark was granted.
CE Marked MD, PMD Conformité Européenne passport of free trade; signifies the device has been declared by an authorized company to conform to a uniform and high degree of safety as measured by technical standards and controlled by your quality management system.
Conformity Assessment Path MD, PMD Path taken for conformity assessment.
Declaration of Conformity Completed MD, PMD Indicates whether there exists a signed statement of compliance to a recognized national or international standard provided in a product submission in lieu of providing data demonstrating conformance to the recognized standard.
Drug Safety Code FV, P, V, PMD Safety code for a drug.
EC Cert MD, PMD Design certs for class III products.
Equipment Type MD, PMD The type of equipment as stated in the Declarations of Conformity.
EU Class MD, PMD Indicates the class of increasing risk to a patient as described by the MDD; classes are described as follows:
  • Class I - devices that pose a low risk to the patient and, except for sterile products or measuring devices, can be self-certified by the manufacturer
  • Class IIa - devices that pose a medium risk; may require assessed quality systems to the ISO 9000/EN46000 standards; invasive in their interaction with the human body, methods of invasion are limited to natural body orifices; may also include therapeutic devices used in diagnosis or in wound management
  • Class IIb - devices that pose a medium risk that may require assessed quality systems to the ISO 9000/EN46000 standards; third-party certification is required; partially or totally implantable in the human body, and may modify the biological or chemical composition of body fluids
  • Class III - devices that pose a high risk and require design/clinical trial reviews, product certification and an assessed quality system; all third-party product and system certification must be conducted by a European notified body (or designee through formal agreement); these devices affect the functioning of vital organs and/or life-support systems
EU Classification Rule MD, PMD EU Classification Rule: Rule 1 through Rule 18, and Rule 99.
Family Code All The code for the product family code you are associating the product with.
Family Name All The name of the product family you are associated the product with.
FDA Device Class MD, PMD FDA classification based on risk:
  • Class I - least risk-laden for which general controls are sufficient to ensure safety and effectiveness
  • Class II - devices for which general controls are determined to be insufficient to provide reasonable assurance of safety and effectiveness, but for which exists sufficient information to establish a performance standard to provide assurance
  • Class III - devices for which there is insufficient information to determine the adequacy of general controls, performance standards or special controls providing reasonable assurance of safety and effectiveness (usually life-supporting or life-sustaining devices)
FDA Product Code MD, PMD Product codes with which the device is associated; identify the product in further detail; for example, Manual Surgical Instruments for General Use contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).
FDA Regulation Number MD, PMD Generic category that is represented by a separate classification regulation found in Title 21 Code of Federal Regulations parts 862-89.
Global Harmonization Task Force Class (GHTF) MD, PMD Class as defined by the GHTF with values 1, 2, 3.
Global Medical Device Nomenclature (GMDN) Code MD, PMD Classification system that allows for the classification of all medical devices put onto the market as defined in the three European Directives.
Indications/Intended Use FV, P, PMD, V A display-only field on the Product Attributes page showing the indications from the product detail sets associated with the product.
Intended Use MD, PMD Intended use of a device (based on Annex 1, I.1; Annex X, 1.1; Annex X, 2.1).
Medical Device Link MD, PMD Number assigned to the device through MDL.
Product Add Comment All Comments you want to share with others in a discussion thread. Will be displayed in the Product Comments box, stamped with the date and time you enter the information and your user ID.
Note: The Product Add Comment field is available on the Create/Modify Product Attributes pages only.
Product Code All The company-specific code for the product. On some pages, the product name is shown with the product code to identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390.
Product Comments All The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them.
Product Concerned Parties All Users who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses.
Product Description All Text that describes the product.
Product Dosage Form FV, P, PMD, V The physical form in which a drug is produced and dispensed. This may be defined at the product level, the component level, or both.
Product Family Type All The type of product family with which the product is associated.
Product Keywords All Words you can use to search for the product.
Product Manufacturing Location MD, PMD Locations of the device manufacturers (assuming there are no product detail sets).
Product Name All The standard product name recognized internally and across countries. On some pages, the product name is shown with the product code to identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390.
Product National Drug Code FV, P, PMD, V NDC; identifies the labeler, product and trade package size.
Component Owner/ RA Responsible All RA person responsible for the component.
Product Route of Administration FV, P, PMD How the product is to be administered. The values that appear for this attribute are based on the dosage form you selected. You may select multiple routes of administration. This may be defined at the product level, the component level, or both.
Product Shelf Life MD, PMD Standard shelf life of the device.
Product Status All The status of the product.
Product Status Date All The date the product status is effective.
Product Sterilization MD, PMD Defines the type of sterilization the device provides.
Product Strength Measure 1 FV, P, PMD, V The minimum value used to define the product strength.
Product Strength Measure 2 FV, P, PMD, V The maximum value used to define the product strength.
Product Strength Unit 1 FV, P, PMD, V The measurement used to quantify the minimum strength.
Product Strength Unit 2 FV, P, PMD, V The measurement used to quantify the maximum strength.
Reason All Reason for creating, modifying or deleting a product.
Reason for Comments Comments related to reason entered by users.
Reason for Termination/Withdrawal All The reason that the product was terminated or withdrawn.
Summary of Technical Documentation (STED) MD, PMD Your STED IDs that apply to the product.
Tech File Number MD, PMD Identifies the technical file that is submitted to the EU for the device.
UMDNS Code MD, PMD UMDNS computer code that is used in ECRI databases and publications, as well as in thousands of health care institutions worldwide for the device.
User ID The user name to validate user identity.
Password The user password to validate user identity.