As the European Commission is unveiling the enforcement of MDR and IVDR, and with the inception of EUDAMED, a lot of concern is now also there on the Basic EU UDI as well along with individual UDI-DI-PI. It is important to understand the concept of basic EU UDI as per the regulations along with its data elements. As per Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) Annex VI Part C definition:
“The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.”
The Basic UDI-DI is the leading entranceway in the database and applicable documentation. Some of the documents which are relevant for the Basic UDI-DI are listed as under:
- Certificates
- Declaration of conformity
- Technical documentation
- Summary of safety
- Clinical performance
The purpose of the basic UDI is to group medical devices with similar anticipated purpose, risk class, and important design and production features. It is however not associated with the individual packaging and labeling of the medical device and it does not appear on any shipped product.
Any Basic UDI-DI must identify the group of medical devices showcased by that Basic UDI-DI in a traceable manner.
Basic UDI-DI Data Elements for Medical Devices
- Applicable legislation (MDR) (*)
- 2. Basic UDI-DI value (*)
- 2b Basic UDI-DI Issuing entity (*);
- 6. Manufacturer SRN (*)
- 5. Name and address of manufacturer
- 7. Name and address and SRN of AR
- 9. Risk class (*)
- Implantable (Y/N) (*)
- For IIb implantable: Suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector (Y/N)
- Measuring function (Y/N) (*)
- Reusable surgical instrument (Y/N) (*)
- Active device (Y/N) (*)
- Intended to administer/remove a medicinal substance (Y/N) (*)
- 11. A. Name and/or, if applicable, device model that identifies the device(s) with this BASIC UDI-DI in the technical documentation and/or certificate or declaration of conformity (Name and/or model shall be provided)
- A.2.2 Certificate IDs (NB, type)
- A.2.11 Clinical Investigations IDs
- A.2.9 Presence of Human tissues/Cells (Y/N) (*)
- A.2.10 Presence of Animal tissues/Cells (Y/N) (*)
- A.2.7 Presence of medicinal product substance (Y/N) (*)
- A.2.8 Presence of medicinal product substance derived from human blood or human plasma (Y/N) (*)
- Special device types: Software (Y/N), contact lenses (Y/N) … (max one choice(Y/N) (*)
- System which is a device in itself (Y/N) (*)
- Procedure pack which is a device in itself (Y/N) (*)
Reference Documents for Basic UDI-DI
Documents where Basic UDI-DI is referenced:
- Technical Documentation (provided to Notified Body in conformity assessment application)
- EU Declaration of Conformity
- Product Certificate
- EU Technical Documentation assessment certificate
- EU type-examination certificate
- EU product verification certificate
- Certificate of Free Sale
- Summary of Safety and Clinical Performance (SSCP) for Medical Devices/ Summary of Safety and Performance (SSP for IVDs)
- Vigilance and Post-Market Surveillance Reports (auto-populated):
- Manufacturer Incident Reporting form (MIR)
- Periodic Summary Update Report (PSUR)
- Field Safety Corrective Action Reporting form (FSCAR form)
- Periodic Summary Report form (PSR)
- Trend reporting form
- Clinical investigation forms for post-market studies
