udi (unique device identification)

  1. Marcelo Antunes

    Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique

    Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in...
  2. Marcelo Antunes

    Informational US FDA issued the first warning letter for UDI violations to help ensure compliance

    The FDA issued the first warning letter for UDI violations to help ensure compliance Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  3. K

    Hospital UDI requirements

    Hello, I know the requirements for medical device manufacturers but what requirements are there for hospitals? Are they required to scan the UDI? If a UDI doesn't scan but the human readable is correct, can you rationalize not relabeling the devices?
  4. J

    FDA Class 1 Medical Device UDI requirements

    I have not found much information on Class 1 minimum requirements. I know the UDI contains the DI and PI but to what extent. Also we make product that could have a blue color, or a red, or a green, does that mean I need a separate UDI for all different colors and options? Just seems overkill...
  5. J

    UDI Requirements - Products that all fall under the same family

    A UDI is composed of two parts: Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model. Production Identifier(s) (PI) So my question is if I am medical device manufacturer and I make a product that all fall...
  6. Marcelo Antunes

    Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI

    MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  7. Marcelo Antunes

    Informational EU – EUDAMED UDI Device Data Dictionary + data sets

    EUDAMED UDI Device Data Dictionary MDR – UDI and device data sets to provide in EUDAMED IVDR – UDI and device data sets to provide in EUDAMED Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  8. M

    EU MDR - UDI requirements and responsibility guidance

    Hi Everyone, Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility? Our company is the legal manufacturer and our distributors are the UDI partners. My question is if our company can delegate this responsibility to our...
  9. A

    UDI requirements for pre-filled combination devices - Box containing a pre-filled device

    Hi! I have a product that has an outer box that contain 2 inner boxes (these 2 inner boxes contain each a prefilled device with the same amount of a drug). The item sold to customers is the outer box. For now, the outer box artwork displays (among other things) the Serial number and not the...
  10. G

    FDA UDI markings "label" vs. "labelling" (labeling)?

    Hello, The typical packaging structure of our devices (sold at OTC retail pharmacies) is: -> device itself (with permanently affixed data plate ... info is affixed either via direct print/silk-screen or via permanent sticker) --> poly-bags, liners, manual, quick start guides, etc ---> retail...
  11. N

    EU MDR Basic UDI-DI and Technical Documentation for Systems

    We are confused about Basic UDI-DI and would like some input on how you're all handling this, especially if you document systems that consist of a system and dependent accessories. In our case, we have monitors and dependent accessories that record things like blood pressure, oxygen saturation...
  12. C

    FDA Medical Device Label Requirements - serial numbers

    Hello all, I've spent the greater part of my entire day and evening trying to find a clear answer to provide to my manager on Monday about the requirements for including serial numbers, manufacturing date, expiry date, lot/batch number, etc. on medical device labeling. We already know the...
  13. Marcelo Antunes

    Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017

    MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Document date: 19/02/2019 - Created by GROW.DDG1.D.4 - Publication date: 19/02/2019 Continue reading at Marcelo's Medicaldevice.expert website... You...
  14. Z

    UDI assignment Criteria Software IVDR

    Hi all, I was hoping to get some of your insights on the IVDR, regarding the UDI assignment Criteria for software the IVDR under Annex VI, Part C states: "6.2.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially...
  15. S

    Looking for procedure on UDI (Unique Device Identification)

    Looking for a procedure on UDI requirements. Thank you!
  16. S

    UDI (Unique Device Identification) Requirements for Remanufactured devices

    Has any one extended UDI requirements for a remanufactured medical device - I was basically interested on how to define a process for a previous UDI over the remanufactured UDI? Thank you,
  17. M

    UDI labeling MDR requirement for reusable medical device accessories

    I have a question regarding UDI label for reusable accessories... According to PART C, Annex VI of MDR there is a requirement Does it mean that there are two possibilities - to place UDI on device itself or on its packaging even if it is possible to (for example) engrave the qr code on the...
  18. Marcelo Antunes

    Medical Device News EU interesting developments – embracing MDSAP and UDI alignment

    Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements. The EU and US will cooperate to ensure alignment of electronic database...
  19. Marcelo Antunes

    Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

    MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Continue reading...
  20. Z

    Direct Part Marking (DPM) requirements for Class II Medical Devices

    All, I have received conflicting advice on Direct Part Marking (DPM), for Class II devices. Our devices are reprocessed and packaged in a kit. The kit has its own UDI information. For the DPM (DI + PI) does it have to be human readable AND AIDC? Thank you!
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