Regulatory Open Forum

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

The symbol is not mandatory in either the EU or the US.

In the EU the requirement in EU-MDR Annex I, 23.2(q) is that the label "have an indication that the device is a medical device". There are many ways to do this including a statement in a language. This however, leads to the translation problem. The common solution is to use the symbol.<o:p></o:p>

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

The symbol is not mandatory in either the EU or the US.

In the EU the requirement in EU-MDR Annex I, 23.2(q) is that the label "have an indication that the device is a medical device". There are many ways to do this including a statement in a language. This however, leads to the translation problem. The common solution is to use the symbol.<o:p></o:p>

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

GS&PR 23.2(q) says that the label "have an indication that the device is a medical device".

GS&PR 23.1(h) says, "Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognized symbols. Any symbol or identification color used shall conform to the harmonized standards or CS. In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

Notice the difference in these two requirements.

23.2(q) is unconditional. A medical device must have an indication that it is a medical device.

23.1(h) is conditional, conditioned on "where appropriate". If a manufacturer decides a symbol is not appropriate, then the manufacturer does not need to use a symbol.

The symbol is not mandatory in either the EU or the US.

In the EU the requirement in EU-MDR Annex I, 23.2(q) is that the label "have an indication that the device is a medical device". There are many ways to do this including a statement in a language. This however, leads to the translation problem. The common solution is to use the symbol.<o:p></o:p>

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

Hi,

I'd like to bump this thread with a related question. MDR requires that labeling identify that a device is indeed a device, and the MD symbol is a recognized symbol which satisfies this requirement. However...does inclusion of this symbol infer that the labeled product is MDR certified, given that this symbol is generally included to satisfy an MDR requirement? Or in other words, is it permissible for a product which is labeled under MDD to include this symbol?

Thanks!

GS&PR 23.2(q) says that the label "have an indication that the device is a medical device".

GS&PR 23.1(h) says, "Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognized symbols. Any symbol or identification color used shall conform to the harmonized standards or CS. In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

Notice the difference in these two requirements.

23.2(q) is unconditional. A medical device must have an indication that it is a medical device.

23.1(h) is conditional, conditioned on "where appropriate". If a manufacturer decides a symbol is not appropriate, then the manufacturer does not need to use a symbol.

The symbol is not mandatory in either the EU or the US.

In the EU the requirement in EU-MDR Annex I, 23.2(q) is that the label "have an indication that the device is a medical device". There are many ways to do this including a statement in a language. This however, leads to the translation problem. The common solution is to use the symbol.<o:p></o:p>

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

First, my personal preference for the Union market is that manufacturers of medical devices should be able to decide whether the MD symbol is or is not appropriate regarding aforementioned GS&PR 23.1(h).  However, when I discussed this question with the Directorate-General for Health and Food Safety, they said that if an internationally recognised symbol (e.g., the ISO 15223-1 MD symbol) is available and cited by a harmonised standard (e.g., EN ISO 15223-1:2021 as amended), then its use should be considered as appropriate.  Accordingly, it may be more work than it is worth, and ultimately may be unsuccessful from a compliance standpoint, to try and argue that the MD symbol isn't appropriate on any Union medical device label. But again, I would personally prefer that manufacturers be allowed to retain the liberty to decide, rather than enduring an MD symbol mandate.

Because the MD symbol is recognized not only by the Union's harmonized EN (European Normalized) version of ISO 15223-1, but is also internationally recognized by way of the base ISO version of ISO 15223-1 (for example, the base ISO version is formally recognized by the U.S. FDA for the U.S. jurisdiction), its appearance on a medical device label doesn't bear any particular meaning regarding the device's conformity with the Union's MDR. Accordingly, it is certainly permissible to use the MD symbol outside of the Union's MDR context, such as, but not limited to, for an MDD legacy device.

On that MDD note, remember that the same fundamental requirement for consideration of the generally recognized state-of-the-art applies to MDD devices as applies for Union MDR devices.  That aspect of the MDD didn't change with the birth of the Union's MDR.  Because EN ISO 15223-1:2021 (as amended) is considered the state-of-the-art regarding label symbols, then the MD symbol is expected for both legacy MDD as well as for Union MDR devices.

Hi,

I'd like to bump this thread with a related question. MDR requires that labeling identify that a device is indeed a device, and the MD symbol is a recognized symbol which satisfies this requirement. However...does inclusion of this symbol infer that the labeled product is MDR certified, given that this symbol is generally included to satisfy an MDR requirement? Or in other words, is it permissible for a product which is labeled under MDD to include this symbol?

Thanks!

GS&PR 23.2(q) says that the label "have an indication that the device is a medical device".

GS&PR 23.1(h) says, "Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognized symbols. Any symbol or identification color used shall conform to the harmonized standards or CS. In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

Notice the difference in these two requirements.

23.2(q) is unconditional. A medical device must have an indication that it is a medical device.

23.1(h) is conditional, conditioned on "where appropriate". If a manufacturer decides a symbol is not appropriate, then the manufacturer does not need to use a symbol.

The symbol is not mandatory in either the EU or the US.

In the EU the requirement in EU-MDR Annex I, 23.2(q) is that the label "have an indication that the device is a medical device". There are many ways to do this including a statement in a language. This however, leads to the translation problem. The common solution is to use the symbol.<o:p></o:p>

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

Kevin,

Thank you for the response - all of this (thankfully) confirms my thinking on the permissibility of the MD symbol on MDD-certified devices.

I do have a follow-up comment about your note that the MD symbol would in fact be expected for both MDD and MDR devices. My understanding of ISO 15223-1 is that it does not itself create labeling requirements, and instead only describes symbols which would satisfy labeling requirements which are stated elsewhere. In this case, MDR includes a requirement that labeling indicate that a device is a device, but MDD does not have a similar requirement. Accordingly, while EN ISO 15223-1:2021 is SOTA regardless of whether a device is certified under MDD or MDR, I would think that the requirement that the MD symbol be included on labeling would only apply for devices conforming with MDR, and not with MDD, despite the inclusion of this symbol in the 2021 edition. But my understanding could be wrong - I appreciate any feedback on this.

Thanks again!

First, my personal preference for the Union market is that manufacturers of medical devices should be able to decide whether the MD symbol is or is not appropriate regarding aforementioned GS&PR 23.1(h).  However, when I discussed this question with the Directorate-General for Health and Food Safety, they said that if an internationally recognised symbol (e.g., the ISO 15223-1 MD symbol) is available and cited by a harmonised standard (e.g., EN ISO 15223-1:2021 as amended), then its use should be considered as appropriate.  Accordingly, it may be more work than it is worth, and ultimately may be unsuccessful from a compliance standpoint, to try and argue that the MD symbol isn't appropriate on any Union medical device label. But again, I would personally prefer that manufacturers be allowed to retain the liberty to decide, rather than enduring an MD symbol mandate.

Because the MD symbol is recognized not only by the Union's harmonized EN (European Normalized) version of ISO 15223-1, but is also internationally recognized by way of the base ISO version of ISO 15223-1 (for example, the base ISO version is formally recognized by the U.S. FDA for the U.S. jurisdiction), its appearance on a medical device label doesn't bear any particular meaning regarding the device's conformity with the Union's MDR. Accordingly, it is certainly permissible to use the MD symbol outside of the Union's MDR context, such as, but not limited to, for an MDD legacy device.

On that MDD note, remember that the same fundamental requirement for consideration of the generally recognized state-of-the-art applies to MDD devices as applies for Union MDR devices.  That aspect of the MDD didn't change with the birth of the Union's MDR.  Because EN ISO 15223-1:2021 (as amended) is considered the state-of-the-art regarding label symbols, then the MD symbol is expected for both legacy MDD as well as for Union MDR devices.

Hi,

I'd like to bump this thread with a related question. MDR requires that labeling identify that a device is indeed a device, and the MD symbol is a recognized symbol which satisfies this requirement. However...does inclusion of this symbol infer that the labeled product is MDR certified, given that this symbol is generally included to satisfy an MDR requirement? Or in other words, is it permissible for a product which is labeled under MDD to include this symbol?

Thanks!

GS&PR 23.2(q) says that the label "have an indication that the device is a medical device".

GS&PR 23.1(h) says, "Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognized symbols. Any symbol or identification color used shall conform to the harmonized standards or CS. In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

Notice the difference in these two requirements.

23.2(q) is unconditional. A medical device must have an indication that it is a medical device.

23.1(h) is conditional, conditioned on "where appropriate". If a manufacturer decides a symbol is not appropriate, then the manufacturer does not need to use a symbol.

The symbol is not mandatory in either the EU or the US.

In the EU the requirement in EU-MDR Annex I, 23.2(q) is that the label "have an indication that the device is a medical device". There are many ways to do this including a statement in a language. This however, leads to the translation problem. The common solution is to use the symbol.<o:p></o:p>

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,

Dears,

Is it mandatory for the MD symbol to be printed on the product label (for the EU and/or the US)? 

Regards,