GxP and Medical Device Compliance Services

UDI and Labelling compliance
for medical device and IVD companies

Consultys can support you in the fast, lean and successful implemenationof all new UDI FDA and EU requirements

 

Unique Device Identification (UDI) will become a mandatory requirement for medical devices over the next few years.

The US Food and Drug Administration (FDA) has put in place legislation for identifying and tracking Medical Devices. The European Commission has released proposed legislation for the same purpose which will be finalised and come into effect over the next few years. In addition to this the International Medical Device Regulators Forum (IMDRF) has recently released guidance notes on this subject. An essential part of all regulation, proposals and guidance documents mentioned above is a database that shall store information on devices and some key characteristics. Manufacturers shall submit information into this database prior to selling a device into a specific market.

Such considerable global efforts come for good reason. A globally harmonized and consistent approach to UDI facilitates positive identification of medical devices and is expected to:

 
Prismond-Medical-Device-UDI.JPG
  • Improve patient safety by reduction of medical errors

  • Provide public access to relevant data

  • Facilitate traceability of devices

  • Enhance vigilance & market surveillance

  • Fight counterfeiting and fraud

  • Support the downstream processes in the supply chain, and clinical and revenue management

UDI /UDID System

The fundamental concepts of the harmonized UDI System outlines the following requirements:

  • Every medical device is identified by a UDI, unless it is exempted

  • The UDI marking is an additional element and does not replace any other required labelling

  • The UDI and UDI Carrier are based on standards

  • A UDI applied to a medical device anywhere in the world can be used globally and meet the UDI requirements of its proper regulatory authority

  • There is no local or national deviating regulation

  • The electronic data are exchangeable between databases (e.g. GUDID in the U.S. and EUDAMED in the EU)

Important UDI Elements (EU MDD)

1.

UDI (Unique Device Identifier)

The UDI is a series of numeric or alphanumeric characters. The UDI contains two parts: Device Identifier (DI) with static data and Production Identifier (PI) with dynamic data, whereas:
  • The DI is globally unique; it is the access key to information stored in a UDI database; and The PI consists of lot or serial number and expiration date
  • A UDI is assigned to the device itself, or its package; higher levels of packaging shall have their own UDI; logistics units are exempt
  • The DI shall be unique at all levels of device packaging At a minimum, a new UDI is required whenever there is a change that could lead to misidentification of the device or ambiguity in its traceability
  • Note: The word “unique” does not imply serialization of every medical device
 

3.

UDID – UDI Database

The European EUCOMED database is still under construction, raising questions as to whether it will be readily available with the release of the MDR. However, manufacturers and any operators with labelling responsibilities should become acquainted with the known general principles, outlined below.
  • An economic operator (manufacturer, authorized representative or importer) must first register with the UDID by submitting data; they will then receive a specific registration number
  • For registration of a device, the manufacturer shall provide the UDI-DI and multiple core data elements related to the manufacturer and the device
  • Neither the UDI-PI nor commercially confidential product information are requested
  • The core data will be available to the public free of charge; they are the minimum elements to identify a device through distribution and use
  • The manufacturer is responsible for initial submission and updates of the data
  • Data on new UDIs must be available at the time the product is placed on the market
  • Changes to a data element that do not require a new UDI, must request an update of the UDID data within 30 days
  • The presence of a device in the UDID does not mean conformity of the device with the regulation

2.

UDI Carrier
  • The UDI Carrier contains DI + PI in a machine (AICD) and human (HRI) readable representation
  • The AIDC data carrier is based on ISO standards (bar code, data matrix, RFID) and follow international recognized coding standards (e.g. GS1, HIBCC)
  • The UDI Carrier sis readable during normal use and throughout the intended lifetime of the medical device; this includes reprocessing and sterilization for reusables
  • Devices that require reprocessing or sterilization between patient use are marked on the device itself in addition to the UDI on the label
  • For implants, the UDI is identifiable prior to implantation
  • For Standalone Medical Device Software, the UDI is assigned at the system level

 

 

 

 

Do you need help with UDI regulations,
UDID UDI Database implementation or regulatory support?
 

UDI: Consultys has Best Practices in Data Management, Labelling, Barcoding,
Direct Marking and Data Submission to EU and FDA System Databases

Consultys UDI Services Overview

Learn more how Consultys can support your organization in the implementation of UDI in a lean and efficent approach.

UDI Regulations and Project Management Services

UDI Regulations and Project Management

  • Unique Device Identification Regulatory Affairs Support (Regulations, Requirements, Timelines)
  • Regulatory Pathway, Implementation and UDI Strategy definition
  • Product Classifications
  • Project Management Support for UDI EU and FDA Project Execution
  • UDI Implementation Strategy
UDI Data Labelling

Data, Labelling and Implementation Support

  • Support during UDI Implementation project in Labelling, Software Implementation, Architecture Design, GUDID Interfaces etc.
  • Gap Analysis to identify gaps in the process, data and application landscape
  • UDI and Labelling Data Collection and Classification
  • Implementation of Prismond GUDID Enterprise Submission Service
UDI Data Submission Service for EU and FDA

Consultys UDI Data Submission Service (EU and FDA)

  • Data Collection, Verification, Transformation, Validation, Submission, Monitoring and Maintanace of UDI Medical Device Data
  • SPL Preparation, Submission and Lifecylcle Management for Medical Device Product Publication in EU and FDAs Database
  • Managed Prismond Service with KPIs and Maintanance Support