Guidance on integrating Unique Device Identification into your Quality Management System

EU MDCG develop guidance note to assist manufacturers

The Unique Device Identification (UDI) System is specified in Article 27 of the Medical Devices Regulation - (EU) 2017/745 - (MDR) and Article 24 of the In Vitro Diagnostic Medical Devices Regulation -  (EU) 2017/746 - (IVDR). The UDI system is intended to:

• allow the identification of medical devices,
• facilitate appropriate traceability,
• enhance the effectiveness of the post-market safety-related activities,
• improve incident reporting,
• enhance targeting field safety corrective actions,
• lead to better surveillance,
• reduce medical errors, and
• help combat counterfeit devices being placed on the market with the intent to mislead and purporting to be from the original manufacturer.

The UDI system is intended to be incorporated into the lifecycle of the device. It can affect many lifecycle processes within an organization’s quality management system (QMS). The UDI is required to be included in the QMS of the manufacturer as defined in Article 10 of the MDR and IVDR.

The Medical Device Coordination Group (MDCG) is composed of representatives of Member States and chaired by the EU Commission. The MDCG has issued a guidance note on integration of the UDI within an organization’s QMS. As with all the MDCG guidance, it cannot be regarded as reflecting the official position of the European Commission, or as being legally binding.

The guidance note covers:

• planning UDI implementation,
• design and development,
• product documentation and retention,
• production processes,
• serious incidents and field safety corrective actions
• purchasing controls,
• documentation and records, and,
• providing data to the Eudamed database.

Appendix I to the guidance note outlines a QMS process for implementing UDI at a manufacturer’s site.

BS EN ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes - is based on a process approach to developing, implementing and improving the effectiveness of the QMS. Understanding and managing interrelated processes as a system contributes to the effectiveness and efficiency in achieving its intended results. Controlling the interrelationships and interdependencies among the processes of the system allows the overall performance of the organization to be improved.  Management of the processes and the overall system can be achieved using a Plan-Do-Check-Act (PDCA) cycle with risk-based approach to take advantage of opportunities and prevent undesirable results. The PDCA cycle consists of four stages:

• Plan – define what needs to be done and the resources to do it,
• Do – implement the planned actions and monitor their effectiveness,
• Check – analyse the results of monitoring and other feedback on the process, and

• Act – take actions to prevent potential failure to achieve intended results, correct any failures that have occurred and implement measures to prevent their recurrence.

The MDCG guidance note gives particular emphasis to planning the introduction of UDI, and identifies the following potential elements of a plan that are consistent with a PDCA cycle:

• analysing the expectations and needs of different stakeholders such as economic operators, healthcare institutions/professionals, patients/users, insurance providers,
• analysing the standards of issuing entities,
• choosing an issuing entity,
• defining internal responsibilities for the implementation and subsequent management of the project plan,
• managing and monitoring implementation of the project plan over time, and
• determining the methods of verifying the operation and continuous compliance of UDI-related QMS processes.

The deadline for implementing UDI-carriers on the labels of implantable and class III devices has now passed. The deadline for implementing UDI-carriers on the device itself for reusable devices, often referred to as direct part marking, is two years after the deadlines for inclusion on the labels. That leaves further deadlines for UDI implementation based on the device risk classification as 26 May in the following years:

• 2023
  • labels for class II devices,
  • labels for class D IVDs
  • direct part marking on reusable implantable and class III devices,
• 2025
  • • labels for class I devices,
    • labels for class C and B IVDs
    • direct part marking on reusable class II devices,
• 2027
  • • • labels for class A IVDs,
      • direct part marking for reusable class I devices.

The clock is ticking to these future deadlines and manufacturers should have their implementation plans in place.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development