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labeling requirements

  1. M

    MDR 2017/745 sterile and non-sterile labeling

    Hi, I'm reaching out to better understand the following definition in the MDR requirement: "The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices...
  2. S

    Medical Device Software Distribution for a CE-marked medical device via a USB memory stick

    Question; if one distributes a software upgrade for a CE-marked medical device via a USB memory stick, is it true that the memory stick must be controlled as a medical device including being labeled as a medical device (in compliance with MDD/MDR labeling requirements with CE-mark), and be...
  3. R

    Labels on sterile packaging

    Can someone please help me on this? For active implantable devices where there are double sterile barriers, is it fine to put labels on secondary barrier instead of primary, since the device goes to the OT room with the secondary barrier and traceability is maintained. In MDR, its quoted as...
  4. 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?
  5. J

    IEC 60601-1, ed 3.1 - Blue icon question

    Some of the product we sell is IEC 60601-1, ed3.1 and proper labeling is applied. Is there any restrictions if the blue icon was placed on a 2nd edition product?
  6. 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...
  7. G

    How is the labeling of units cleared for both Rx and OTC uses handled?

    Hello, For a unit which 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary - how is the labeling supposed to be handled? - one set of artwork for the OTC unit ... a version without Rx functions enabled or claimed? - a separate set of artwork for...
  8. E

    FDA Supplier Labeling Requirements

    Hi all, I work for a component supplier (not a "component" as the FDA defines it) for several medical device manufacturers. We do not manufacture a finished device but we are ISO 13485 certified. The only labeling requirements I can think of are that we have a process specified (product and...
  9. L

    Class IIa Medical Device, CE Mark & 510k - Labeling Content

    We have a class IIa medical device with CE registration and 510k filing underway. For the 510k filing the IFU and labelling had to changed with among those changes a Rx only symbol. This triggered a discussion as the inteded use of the device contains: "shall be used in a clinical environment...
  10. R

    US FDA Mandatory Labelling contents for an OTC medical device

    Hi, Please let me know which clause in 21 CFR will speak about mandating the date of manufacture for OTC medical device. When I searched, I could find that 21 CFR part 801 covers about format of dates used in the packaging but no specific requirement on the mandate of manuacturing date. If...
  11. M

    Technical File (STED) labelling - When you compile tech files do we have to include all the product labels?

    Hi Everyone, I was wondering when you compile tech files do we have to include all the product labels? How do you define representative product labels? Thanks!
  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. S

    Expiration Date (use by date) on a product label

    I recall hearing or reading that the MDR will be requiring the expiration date (use by date) on a product label to include the day of the month, using the format of yyyy-mm-dd. Is that correct, or can it continue to be just the year and the month? I should mention that the date is on an entire...
  14. M

    Authorised Representative Contact Information

    Curious: I've been scanning the MDD, MDR, and MEDDEV 2.5/10 for references to required Authorised Representative contact information, and all I can seem to find is that only name and address are required. Is this correct? Aren't they are supposed to be contactable within a timeframe from...
  15. M

    Over-labelling - Any requirements or best-practices?

    Situation: Our manufacturer address changes. Because the large stock of labels, packaging, and printed manuals that all have the old address, we are considering over-labelling (applying a label with the new address over the old address, but otherwise other labelling content is unaffected). A...
  16. S

    New problems exporting to Germany - February 2019

    Is anyone else having issues exporting medical devices to Germany? For many years, our CE marked product has been "over-labeled" by our German distributor so that the Instructions For Use are in German when sold to the hospital. We've now had two shipments held up. Our distributor talked with...
  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. L

    EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content

    Hi all, I was hoping to get some guidance regarding the labelling requirements for devices/ articles which contain CMRs or substances with endocrine-disrupting (ED) properties. I understand that where there is a concentration above 0.1% w/w, a reference to these substances must be made on the...
  19. A

    Class I medical device and Category III PPE - Long length gloves

    Hi All Covers, We wanted to produce a long length gloves that are both a Class I medical device and Category III PPE. This gloves will be packed in a dispenser. What would be the marking and labeling requirements for this glove? Should we label and mark on the glove itself? Does it need to come...
  20. I

    Requirements for different Labeling Levels

    For the following three examples: Gloves do not have individual packaging. 100 gloves are provided per box Each suture is sealed in a pouch. 10 pouches are provided in a box. Each graft is sealed in a pouch. 1 pouch is provided in a box. For example 1 it's sufficient to only place labeling...
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