July 31, 2021
The European Medical Device Coordination Group (MDCG) has published new recommendations for medical device manufacturers on integrating Unique Device Identification (UDI) data into their quality management systems according to Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR) requirements.
The MDCG guidance covers UDI integration requirements for economic operators including medical device and IVD manufacturers as well as distributors and importers bearing the same compliance obligations as manufacturers in the European Union. Impact of UDI-related data on device lifecycles processes necessitates guidelines specific to integration with QMS processes, according to MDCG.
The guidance lists several recommended sections to include in a UDI-QMS integration plan for a medical device or IVD product:
- Design and development
- Product documentation and retention
- Production and process
- Serious incidents and field safety corrective actions (FSCA)
- Purchasing controls
- Documentation and records
- Enterprise resource planning
- UDI data provided to the Eudamed database
Design and development considerations for UDI implementation
First, MDCG recommends that manufacturers consider the objectives as well as effects of UDI compliance, including assigning UDI and Basic UDI Device Identifier (UDI-DI) information, when designing and developing their devices. Companies should make sure that UDI-DI assignments are in place before placing devices on the EU market, and before submitting Technical Documentation to Notified Bodies for conformity assessments and CE Mark certification.
Manufacturers should also their UDI Production Identifier (UDI-PI) assignments comply with production identifier rules laid out in Annex VI of the MDR and IVDR. Documentation of all UDI assignment, changes and traceability will be necessary, as well.
Product documentation and retention rules
Second, manufacturers are required to maintain up-to-date lists of all UDIs assigned to their devices as part of their technical documentation. Technical documentation including lists of UDIs must remain available to relevant EU Competent Authorities for at least 10 years following market entry of last device covered by a manufacturer’s declaration of conformity; for implantable devices, a 15-year minimum is required.
UDI data for production and process
Manufacturers may also opt to use UDI information for product information management, according to the MDCG guidance. For example, a manufacturer may use the UDI-DI of a device as a reference or catalogue number.
“The manufacturer should decide for each individual type/model when, where, and how the UDI carrier should be applied following various timelines per risk class, as required by the MDR/IVDR,” states the guidance.
Furthermore, in cases where direct marking of UDI data on a device is not feasible, manufacturers should document exceptions to direct marking requirements according to MDR and IVDR provisions.
Finally, MDCG’s production and process recommendations include special mention of labeling considerations for manufacturers:
Label printing processes should be verified and validated in line with firms’ QMSs;
Any changes to validated processes should be evaluated to determine effects on labeling;
Companies should monitor that software used for UDI system implementation be kept validated.
Serious incidents and FSCAs
MDR Article 27(5) and IVDR Article 24(5) both mandate that manufacturers use UDI information to report serious incidents and FSCAs; these requirements should be incorporated into companies’ internal procedures and processes.
UDI and purchasing controls
The guidance notes that although components and parts of purchased components only fall under UDI requirements if they are considered medical devices under MDR or IVDs under IVDR, manufacturers should review their purchasing procedures with the following issues in mind:
Do existing purchasing activities and controls involve materials and/or equipment such as label materials, printers or scanners that may affect your UDI system compliance?
Do existing purchase activities involve parts, materials and/or equipment placed on the EU market as medical devices, and for which you must meet compliance obligations as a manufacturer according to MDR requirements?
Have purchased goods that are subject to UDI requirements been identified, processed and recorded appropriately?
Documentation and records
This section of the MDCG guidance lists where basic UDI-DI information should appear, including vigilance and post-market surveillance reports; EU Declarations of Conformity; technical documentation; Summaries of Safety and Clinical Performance; and certificates of free sale (CFS).
In addition, UDI information that includes both UDI-DI and UDI-PI should be listed on labels or devices and packaging. Manufacturers should also reference this UDI data in their technical documentation.
Enterprise resource planning
Manufacturers using enterprise resource planning systems for UDI data capture should maintain validation documentation for processes and equipment including printer software linkage, UDI metadata collection for UDI creation and validation of M2M connectivity to Eudamed.
UDI data provided to Eudamed
MDCG’s final recommendation for integrating UDI with medical device and IVD manufacturers’ quality management systems involves submission of required device information to the Eudamed UDI database.
Specifically, manufacturers should establish processes to verify that device information submitted to Eudamed is kept updated to ensure ongoing compliance per MDR and IVDR requirements.