Regulatory Open Forum

2 questions tied to IFU glossaries. My company sells globally (MDSAP countries, EU, and many others):
1. We currently plan to translate our IFUs and labels into >30 languages and we do not have country-specific labeling, therefore our IFUs are growing significantly in size. To support the production of these IFU's with the increase in size (with new MDR content), we are proposing having the glossary be its own "insert" in each kit separate from the IFU, and then also include the product-specific IFU (since the glossary will need to be translated). The glossary included in each kit (finished product) would include all symbols that would appear on all types of CIVCO product and therefore would have 1 part number that appears on all finished product BOMs. Each kit would then have a product specific IFU with  how to use, warnings and precautions, etc. Is there any reason we couldn't do this from a Regulatory compliance standpoint? Is it absolutely required that the glossary is within the IFU itself? 

2. Is there a regulatory requirement that the IFU glossary has to point to the applicable ISO/IEC standard? For example, I have seen companies that reference ISO 15223-1 and the specific symbol reference number (for example, 5.1.1). Can the glossary just contain the name of the symbol and description of the symbol? Again, trying to consider table size, quantity of translations, etc. if it is not needed we do not plan to include it but if it is, we need to get it incorporated.

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Allyson Swartz
Quality Engineer II
Coralville IA
United States
------------------------------

Allyson,
See the attached Guidance issued by MedTech Europe on "Use of Symbols to Indicate Compliance with the MDR' published May 2019, specifically this paragraph on page 4, and Annex I that contains the translations.
"These symbols can be used internationally. They must be described in the Instructions for Use in line with the MDR 23.1. h) until they are published in a harmonised standard. Note, that jurisdictions outside of the EU may have different requirements regarding the 'Information to be Supplied by the Manufacturer'."

SPR 23.1 (h) says that is "largely aligns with MDD ER 13.2 relative to the use of internationally recognized symbols and colors from harmonized standards but also references conformity to 'CS' (see text box above) if they exist. The latter is a new concept with the introduction of this Regulation. Although harmonized standard EN 980:2008 exists for medical device symbols, additional symbols can be found in other standards not currently harmonized (at time of writing) under the MDD, such as ISO 15223:2016 (symbols for medical device labels), IEC 60417 (graphical symbols for equipment), IEC 60878 (graphical symbols for medical electrical equipment) and others. These international standards can be sources to establish 'state of the art' for manufacturers in the absence of appropriate symbols in the main harmonized standards or existing CS.

I don't think it matters so much where the symbols glossary is included in the IFU, as that it is actually included. In your case, you could possibly state that the symbols glossary, while separate from the product IFU, is still itself a type of IFU. Regarding the standard reference number, yes it should be included so the source of the symbol is clear.

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Lena Cordie-Bancroft
Victoria MN
United States
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Original Message:
Sent: 28-Aug-2019 15:39
From: Allyson Swartz
Subject: IFU Glossary Questions EU MDR and Global

2 questions tied to IFU glossaries. My company sells globally (MDSAP countries, EU, and many others):
1. We currently plan to translate our IFUs and labels into >30 languages and we do not have country-specific labeling, therefore our IFUs are growing significantly in size. To support the production of these IFU's with the increase in size (with new MDR content), we are proposing having the glossary be its own "insert" in each kit separate from the IFU, and then also include the product-specific IFU (since the glossary will need to be translated). The glossary included in each kit (finished product) would include all symbols that would appear on all types of CIVCO product and therefore would have 1 part number that appears on all finished product BOMs. Each kit would then have a product specific IFU with  how to use, warnings and precautions, etc. Is there any reason we couldn't do this from a Regulatory compliance standpoint? Is it absolutely required that the glossary is within the IFU itself?

2. Is there a regulatory requirement that the IFU glossary has to point to the applicable ISO/IEC standard? For example, I have seen companies that reference ISO 15223-1 and the specific symbol reference number (for example, 5.1.1). Can the glossary just contain the name of the symbol and description of the symbol? Again, trying to consider table size, quantity of translations, etc. if it is not needed we do not plan to include it but if it is, we need to get it incorporated.

------------------------------
Allyson Swartz
Quality Engineer II
Coralville IA
United States
------------------------------

The US FDA has rules about the use of symbols in labeling, including a need to identify the standard/organization the symbol came from: https://www.fda.gov/medical-devices/device-labeling/use-symbols-labeling

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 28-Aug-2019 20:26
From: Lena Cordie-Bancroft
Subject: IFU Glossary Questions EU MDR and Global

Allyson,
See the attached Guidance issued by MedTech Europe on "Use of Symbols to Indicate Compliance with the MDR' published May 2019, specifically this paragraph on page 4, and Annex I that contains the translations.
"These symbols can be used internationally. They must be described in the Instructions for Use in line with the MDR 23.1. h) until they are published in a harmonised standard. Note, that jurisdictions outside of the EU may have different requirements regarding the 'Information to be Supplied by the Manufacturer'."

SPR 23.1 (h) says that is "largely aligns with MDD ER 13.2 relative to the use of internationally recognized symbols and colors from harmonized standards but also references conformity to 'CS' (see text box above) if they exist. The latter is a new concept with the introduction of this Regulation. Although harmonized standard EN 980:2008 exists for medical device symbols, additional symbols can be found in other standards not currently harmonized (at time of writing) under the MDD, such as ISO 15223:2016 (symbols for medical device labels), IEC 60417 (graphical symbols for equipment), IEC 60878 (graphical symbols for medical electrical equipment) and others. These international standards can be sources to establish 'state of the art' for manufacturers in the absence of appropriate symbols in the main harmonized standards or existing CS.

I don't think it matters so much where the symbols glossary is included in the IFU, as that it is actually included. In your case, you could possibly state that the symbols glossary, while separate from the product IFU, is still itself a type of IFU. Regarding the standard reference number, yes it should be included so the source of the symbol is clear.

------------------------------
Lena Cordie-Bancroft
Victoria MN
United States

Original Message:
Sent: 28-Aug-2019 15:39
From: Allyson Swartz
Subject: IFU Glossary Questions EU MDR and Global

2 questions tied to IFU glossaries. My company sells globally (MDSAP countries, EU, and many others):
1. We currently plan to translate our IFUs and labels into >30 languages and we do not have country-specific labeling, therefore our IFUs are growing significantly in size. To support the production of these IFU's with the increase in size (with new MDR content), we are proposing having the glossary be its own "insert" in each kit separate from the IFU, and then also include the product-specific IFU (since the glossary will need to be translated). The glossary included in each kit (finished product) would include all symbols that would appear on all types of CIVCO product and therefore would have 1 part number that appears on all finished product BOMs. Each kit would then have a product specific IFU with  how to use, warnings and precautions, etc. Is there any reason we couldn't do this from a Regulatory compliance standpoint? Is it absolutely required that the glossary is within the IFU itself?

2. Is there a regulatory requirement that the IFU glossary has to point to the applicable ISO/IEC standard? For example, I have seen companies that reference ISO 15223-1 and the specific symbol reference number (for example, 5.1.1). Can the glossary just contain the name of the symbol and description of the symbol? Again, trying to consider table size, quantity of translations, etc. if it is not needed we do not plan to include it but if it is, we need to get it incorporated.

------------------------------
Allyson Swartz
Quality Engineer II
Coralville IA
United States
------------------------------

#1 is really up to you and you can define both of them as IFUs related to the product. Also remember that there are manufacturers out there who can make an IFU that will fit and with all translations. Amazing paper folding that I'm sure we've all seen in some OTC products.

#2 Just adding on to what Lena has to say, it is also an FDA requirement:
FDA plans to continue to recognize symbols under its authority in section 514(c) of the FD&C Act for subsets of devices and/or subsets of users, as appropriate. Because the final rule does not limit the use of symbols to those in FDA-recognized standards, manufacturers have the option to use stand-alone symbols in the labeling for any medical device, as long as the symbol is established in a standard developed by an SDO and explained in a symbols glossary as provided in the standard and the manufacturer determines that the stand-alone symbol on its particular device otherwise satisfies section 502(c) of the FD&C Act. - https://www.federalregister.gov/documents/2016/06/15/2016-13989/use-of-symbols-in-labeling
Hence all medical devices being sold in the US have a glossary that requires manufacturers to state where (which SDO EN 980 or ISO 15223) and which sections they got the symbol from, besides simply explaining it. FDA is also ok with manufacturers making their own symbol if they can't find it in an SDO somewhere. However, it has to follow the ISO standard for making symbols. This is the only way FDA is ok with the use of symbols in product labels without any sort of explanation like we used to (it was a pain before because I had to make sure everything fits (e.g. the quick phrase explanation of the manufactured by symbol has to be next to it's symbol ON the label - that's how it used to be before 2016).

Hope that helps,
​​

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Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
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Original Message:
Sent: 28-Aug-2019 15:39
From: Allyson Swartz
Subject: IFU Glossary Questions EU MDR and Global

2 questions tied to IFU glossaries. My company sells globally (MDSAP countries, EU, and many others):
1. We currently plan to translate our IFUs and labels into >30 languages and we do not have country-specific labeling, therefore our IFUs are growing significantly in size. To support the production of these IFU's with the increase in size (with new MDR content), we are proposing having the glossary be its own "insert" in each kit separate from the IFU, and then also include the product-specific IFU (since the glossary will need to be translated). The glossary included in each kit (finished product) would include all symbols that would appear on all types of CIVCO product and therefore would have 1 part number that appears on all finished product BOMs. Each kit would then have a product specific IFU with  how to use, warnings and precautions, etc. Is there any reason we couldn't do this from a Regulatory compliance standpoint? Is it absolutely required that the glossary is within the IFU itself?

2. Is there a regulatory requirement that the IFU glossary has to point to the applicable ISO/IEC standard? For example, I have seen companies that reference ISO 15223-1 and the specific symbol reference number (for example, 5.1.1). Can the glossary just contain the name of the symbol and description of the symbol? Again, trying to consider table size, quantity of translations, etc. if it is not needed we do not plan to include it but if it is, we need to get it incorporated.

------------------------------
Allyson Swartz
Quality Engineer II
Coralville IA
United States
------------------------------