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MDR Labelling

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Liliana Created:   Apr 15, 2021 Last commented:   Apr 20, 2021

MDR Labelling

For a company that manufactures textile medical devices having all the required information but the date of manufacture (the expiration date is not applicable) on a woven label which is directly sewn onto the medical device, is it acceptable under the MDR to have the date of manufacture printed on a sticker label which will be placed on the device`s first level of packaging - plastic bag (every device is packaged individually)?  

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 17, 2021

There must be date of the production direct on the product. Did you consider to put a UDI number on the woven label? 

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Liliana Apr 19, 2021

We are condering having a UDI number printed on a label which will be attached directly on the product, as our products are textiles and reusables (need to be laudered too). However, due to this reason, our understanding is that we have to comply with the UDI under MDR from 2027, is that correct? Would suffice to have the UDI on the products themselves and the date of manufacture on their bag then?

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Kristina Zvonar Brkić Apr 20, 2021

Yes, you are right that for reusable medical devices class I the deadline is to put UDI until 26th May 2027. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging and in case of reusable devices on the device itself (direct marking). The UDI carrier for reusable devices that require disinfection, sterilization, or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for subsequent use throughout the intended lifetime of the device.

As a part of the UDI you can put the date of the production (in the part UDI-PI) therefore, thus all elements of traceability can be satisfied.

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Apr 15, 2021

Apr 20, 2021

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