Global Regulatory Pulse

Planning for Success: UDI Requirements Under the EU MDD/MDR

In European Market, FDA, Regulatory by Dr. Susanne Beckert

A stunning new chapter opened up with the recast of the MDD (Medical Device Directive) which is to become MDR (Medical Device Regulation) legislation in Q3-2017, presumably. Several articles and a comprehensive annex describe the new requirements for a harmonized system of unique device identifier (UDI), their carrier and the UDI database (UDID), EUDAMED.

Implementing the new EU UDI imposes a significant challenge to manufacturers in many technical, administrative and operative aspects. At the same time, economic operators who understand the importance of complying early will likely observe business advantages such as better inventory control and improved adverse event management, not to mention, the potential to reduce healthcare fraud and to create transparency throughout the distribution chain.

UDI History

In 2007, the U.S. FDA developed a labelling system that would uniquely identify every single medical device (MD) on the market. The Global Harmonization Task Force (GHTF) soon recognized the global relevance of such a system and adopted a respective guidance that was last released in 2013 by the International Medical Device Regulators Forum (IMDRF), an international cooperation of regulators made up of industry stakeholders and GHTF successors. (Interestingly, Medical device manufacturers experienced in the U.S. market have quickly recognized the similarity of the EU regulation as compared to the U.S. Food and Drug Administration’s (FDA) UDI guidelines.)

In parallel, the EU commission embraced the idea of a European UDI system and issued a respective recommendation in 2013. The EU UDI now takes substantial part in the profound revision of the European MDD Directive 93/42, amended 2007, which is assumed to be legislatively effective beginning March 2017 as Medical Device Regulation.

The EU UDI System, like the U.S. UDI requirements, will be implemented in steps, starting with the highest risk classes first, and lowest risk classes last.

UDI Objectives

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:

  • 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)

I. 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

II. 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 AIDC format is favored in case of significant space constraints on the device or packaging; however, the use outside of healthcare facilities requires HRI on the label
  • In case of multiple bar codes on the same package, the UDI carrier is ‘readily identifiable’
  • 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

III. 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
  • The UDID should allow for the linking of all the packing levels of the product
  • The UDID should use international standards for data exchange
  • Local or national UDID may contain additional attributes

Outlook for Manufacturers & Planning for Success

These new and extensive EU labelling requirements pose major challenges for manufacturers wishing to begin or sustain medical device businesses under the upcoming MDR. As such, it is critical to create a strategy that will lead to successful implementation under the updated UDI system and requirements. Below are a few helpful suggestions for medical device organizations in managing their transitions.

  • First and foremost, start to implement the change now, and plan accordingly. Embrace the chance to streamline your data systems and labels on all levels. Streamlined processes will support your readiness to fulfill further new labelling requirements, emphasize pre-clinical and clinical data and enhance post-market surveillance in the upcoming MDR.

Considerations for preparation should include:

  • Determine all processes and interfaces involved in the design, manufacture and application of device labels and assign responsibilities; consider your external distribution partners
  • Perform high-level GAP assessments of current organization, labels, equipment and processes to fulfill the EU UDI requirements
  • Set up dedicated programs with cross-functional teams to get ready for the MDR
  • Get membership with an issuing agency (e.g. GS1, HIBCC) to obtain a company code
  • Define data carrier and content
  • Assign identification numbers to all devices and packaging levels including kits, complex systems and combination products
  • Implement data management systems to collect, update and transfer data elements
  • Evaluate all coding systems for their abilities and upgrade where needed
  • Invest in the installation, qualification and validation of equipment and software
  • Train staff and identified partners appropriately
  • Establish a system to ensure data quality
  • Implement a change control process for new and modified data
  • Roll out to all assortments, starting with highest risk class in accordance with the UDI timeline
  • Submit required data to UDID

To gain the full benefit from a UDI system, all stakeholders within the distribution chain – including healthcare institutions (even if not assigned by the regulation) – should consider developing processes for receiving, identifying and stocking of devices in accordance with the newly defined EU UDI System.

Not sure where to start?

The implementation and adoption process can be overwhelming for any medical device organization when a new regulation is released. That’s why having the right partner, at the right time, can be invaluable in continuing uninterrupted, streamlined operations that lead to market success. NAMSA’s global regulatory experts welcome the opportunity to discuss the new EU MDR requirements with you, including the potential impact to your business, and how the right strategy and implementation process can help you plan for success. Please contact us at communications@namsa.com if you would like to discuss the new EU MDR, or visit our regulatory consulting webpage, here, to learn about our services.

 

Authors:

Dr. Susanne Beckert serves as Principal MRS, Regulatory and Quality, for NAMSA.