Regulatory Open Forum

A device we are importing from the EU has some regulatory symbols I am not familiar with in the States, and also which are not referenced in ISO 15223. Can anyone provide any insight on what these symbols mean or what standard to purchase with their glossary. 




Thanks.

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Valerie Torres
Houston TX
United States
------------------------------

Hi Valerie,

These symbols do not appear in the harmonized standard EN ISO 15223, as you have seen. As a result they must be explained in the IFU on meaning. There you should look.
If there is no information in the IFU, you can start being suspicious towards you supplier. Let them present the applicable CE certificate and related Declaration of Conformity (with product list containing the products you want to purchase).
On the other hand, these products (if they are medical devices) need to comply with USA labeling requirements. Focusing on that might also result in some critical questions towards your supplier.

------------------------------
Robert van Boxtel
Principal Consultant Medical Device Project B.V.
Alphen a/d Rijn
Netherlands
------------------------------

Original Message:
Sent: 20-Jul-2022 12:10
From: Valerie Torres
Subject: Device labeling Symbols

A device we are importing from the EU has some regulatory symbols I am not familiar with in the States, and also which are not referenced in ISO 15223. Can anyone provide any insight on what these symbols mean or what standard to purchase with their glossary.




Thanks.

------------------------------
Valerie Torres
Houston TX
United States
------------------------------

Hi Valerie,

Those symbols you highlighted I do not recognise except through experience in different types of application such as '1x' only used one time or double-arrows cross-out could indicate not interchangeable.  If a company creates symbols these need to be defined and explained in the Instructions for Use (IFU) as Robert indicated.  Companies can use different symbols or internally generated symbols, but they need to be defined.  You might want to ask the company where you got the label/packaging for them to explain what the symbols are and what they mean.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 21-Jul-2022 04:39
From: Robert van Boxtel
Subject: Device labeling Symbols

Hi Valerie,

These symbols do not appear in the harmonized standard EN ISO 15223, as you have seen. As a result they must be explained in the IFU on meaning. There you should look.
If there is no information in the IFU, you can start being suspicious towards you supplier. Let them present the applicable CE certificate and related Declaration of Conformity (with product list containing the products you want to purchase).
On the other hand, these products (if they are medical devices) need to comply with USA labeling requirements. Focusing on that might also result in some critical questions towards your supplier.

------------------------------
Robert van Boxtel
Principal Consultant Medical Device Project B.V.
Alphen a/d Rijn
Netherlands

Original Message:
Sent: 20-Jul-2022 12:10
From: Valerie Torres
Subject: Device labeling Symbols

A device we are importing from the EU has some regulatory symbols I am not familiar with in the States, and also which are not referenced in ISO 15223. Can anyone provide any insight on what these symbols mean or what standard to purchase with their glossary.




Thanks.

------------------------------
Valerie Torres
Houston TX
United States
------------------------------

Thank you, Robert and Richard for your confirmation. I did not see these symbols included with a glossary in the IFU as well and have requested this information from the supplier.

------------------------------
Valerie Torres
Houston TX
United States
------------------------------

Original Message:
Sent: 21-Jul-2022 04:39
From: Robert van Boxtel
Subject: Device labeling Symbols

Hi Valerie,

These symbols do not appear in the harmonized standard EN ISO 15223, as you have seen. As a result they must be explained in the IFU on meaning. There you should look.
If there is no information in the IFU, you can start being suspicious towards you supplier. Let them present the applicable CE certificate and related Declaration of Conformity (with product list containing the products you want to purchase).
On the other hand, these products (if they are medical devices) need to comply with USA labeling requirements. Focusing on that might also result in some critical questions towards your supplier.

------------------------------
Robert van Boxtel
Principal Consultant Medical Device Project B.V.
Alphen a/d Rijn
Netherlands

Original Message:
Sent: 20-Jul-2022 12:10
From: Valerie Torres
Subject: Device labeling Symbols

A device we are importing from the EU has some regulatory symbols I am not familiar with in the States, and also which are not referenced in ISO 15223. Can anyone provide any insight on what these symbols mean or what standard to purchase with their glossary.




Thanks.

------------------------------
Valerie Torres
Houston TX
United States
------------------------------