Medical Device Maintenance

Values for Medical Device are managed in the Data Administration for use on the Product Component Device

Details Attributes page.

The Medical Device Data Administration section provides capability to capture Component UDI attributes for a Product at the Application level based on country. It helps to distinguish a Medical Device RIM Component that is co-packaged with a RIM Pharmaceutical Product.

When you select a value under Medical Device Maintenance, a page opens with a table of all values that have been defined. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

Appropriate data administration privileges are required to view and modify Medical Device Maintenance values.

Medical Device Maintenance: Medical Device Values

Ennov InSight lets you use Data Administration to add and modify Medical Device values and attributes, and to set statuses on those attributes.

You can create and maintain the following Medical Device values:

Device Classification Attributes

To define a define classification value, enter values for the following attributes:

EU Device Nomenclature Category Attributes

To define an EU device nomenclature category value, enter values for the following attributes:

FDA GMDN In-Vitro Term Type Attributes

To define FDA GMDN in-vitro term type value, enter values for the following attributes:

EU Category of CMR Type Attributes

To define an EU category of CMR type value, enter values for the following attributes:

EU Device Nomenclature Attributes

To define an EU device nomenclature value, enter values for the following attributes:

Global Medical Device Nomenclature (GMDN) Code Attributes

To define a global medical device nomenclature (GMDN) code value, enter values for the following attributes: