Regulatory Open Forum

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

Hello Robert,

The "MD" with box around it for the Medical Device symbol was added in the latest ISO 15223-1 standard with some strong influence from the European Union.  While this may be common sense for many types of devices, i.e. catheters, implants, there are other devices which may not be so clear, i.e. aesthetic products, aesthetic laser, accessories.  In fact, probably accessories are one of the main points of this to clearly indicate which products would be regulated and which would not.  It may seem - hmmmm - why would I need these for products which are clearly medical devices?  Though if claiming compliance to ISO 15223-1, and the GSPR in the EU MDR/EU IVDR, than the symbol would be needed.  To answer your question, most regulations do not require the shipping box/container to meet the requirements, so companies can use discretion and flexibility for the shipping labelling.  There is not a down-side to having the MD symbol on the shipper box and it is not required - I would say company choice like most do with their shipping labels.

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

Hello Robert,

The "MD" with box around it for the Medical Device symbol was added in the latest ISO 15223-1 standard with some strong influence from the European Union.  While this may be common sense for many types of devices, i.e. catheters, implants, there are other devices which may not be so clear, i.e. aesthetic products, aesthetic laser, accessories.  In fact, probably accessories are one of the main points of this to clearly indicate which products would be regulated and which would not.  It may seem - hmmmm - why would I need these for products which are clearly medical devices?  Though if claiming compliance to ISO 15223-1, and the GSPR in the EU MDR/EU IVDR, than the symbol would be needed.  To answer your question, most regulations do not require the shipping box/container to meet the requirements, so companies can use discretion and flexibility for the shipping labelling.  There is not a down-side to having the MD symbol on the shipper box and it is not required - I would say company choice like most do with their shipping labels.

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

This symbols helps understand what regulation is leading for CE-marking. 'MD' should result in understanding these are MDR certified products, similar to IVDs under the IVDR. However, for a reason which is unknown (unless we assume it is sloppy law making...) accessories to medical devices are not required to have this symbol. The reason for that is, that the requirement demanding this logo speaks of 'medical devices', a term that excludes accessories, instead of 'devices' which includes this term. This also excludes Annex XVI devices. 

The MD symbol is thereby a symbol that may create more confusion than it solves. 

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

Is the MD identifier required on the device label AND the packaging label?

This symbols helps understand what regulation is leading for CE-marking. 'MD' should result in understanding these are MDR certified products, similar to IVDs under the IVDR. However, for a reason which is unknown (unless we assume it is sloppy law making...) accessories to medical devices are not required to have this symbol. The reason for that is, that the requirement demanding this logo speaks of 'medical devices', a term that excludes accessories, instead of 'devices' which includes this term. This also excludes Annex XVI devices. 

The MD symbol is thereby a symbol that may create more confusion than it solves. 

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

2017/745 requires the symbol or text only on the device label, which can be on the device itself or the device package as appropriate. I don't see any harm in putting it on multiple levels

Is the MD identifier required on the device label AND the packaging label?

This symbols helps understand what regulation is leading for CE-marking. 'MD' should result in understanding these are MDR certified products, similar to IVDs under the IVDR. However, for a reason which is unknown (unless we assume it is sloppy law making...) accessories to medical devices are not required to have this symbol. The reason for that is, that the requirement demanding this logo speaks of 'medical devices', a term that excludes accessories, instead of 'devices' which includes this term. This also excludes Annex XVI devices. 

The MD symbol is thereby a symbol that may create more confusion than it solves. 

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

Different jurisdictions approach the MD symbol differently; thus it is necessary to assure we have given account for each jurisdiction.  For example,

• If the MD symbol is present on U.S. device labeling, then the MD symbol shall also be accompanied by adjacent explanatory text or be explained in an accompanying symbols glossary.  As the MD symbol isn't a U.S. requirement, the presence of the MD symbol can unnecessarily complicate the U.S labeling, especially if the MD symbol is on the shipper box.  This is because of FDA's very liberal interpretation of its statutory definitions for 'label' and 'labeling' and the statutory labeling term "accompanying" which causes such information to become regulated labeling information even if placed on an over-pack shipper.  If one chooses to place such information on the over-pack shipper, then that content and artwork must then come under document/design controls.  Accordingly, so as not to overcomplicate and bloat the firm's regulatory/QMS mechanisms, I would avoid putting such information on the over-pack shipper.

• Regarding Europe, put simply, the MD symbol is definitely required (i.e., it's not optional) for medical devices.  Specifically, it shall appear on the "label".  This is due to the combination of GSPR 23.1(h) and 23.2(q).  This was confirmed to me by the European Commission.  Yet my understanding is that the MDR's definition for "label" doesn't generally include an over-pack shipper box.  For example, we have a hint of that principle over in the UDI section, where the UDI (a critically-important label element) isn't required to be on the shipper.  I have not heard of a scenario where products were held by European customs because an over-pack shipper lacked the MD symbol.

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

Hi Kevin, I'd be interested to understand what the Commission actually confirmed for you. Practically, I agree that using the MD symbol is the way to go for EU bound devices but I am struggling with the 'definitely required' piece.

I agree that if a symbol is being used to identify the product as a medical device in the EU, then the MD symbol is given in the harmonised EN standard and thus is 'required' as per GSPR 23.1 (h). But if a symbol is not being used, then there is no requirement in the MDR that says a symbol must be used. I acknowledge that in most cases, products bound for the EU will be going to multiple markets and thus will require multiple languages, so the use of a symbol instead of said identification as a medical device in multiple languages is more logical. But if only one language is needed, it is feasible to use text only and not replace with a symbol. I suspect only a court of law could ultimately decide on the validity of a manufacturer's rationale for what was deemed 'appropriate' in meeting GSPR 23.1 (h), although it is highly unlikely we'd ever get that 'truth' rather the acceptance of the interpretation by all parties during the conformity assessment rather than taking legal action.

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 05-Jan-2024 14:35
From: Kevin Randall
Subject: MD Symbol purpose

Different jurisdictions approach the MD symbol differently; thus it is necessary to assure we have given account for each jurisdiction.  For example,

• If the MD symbol is present on U.S. device labeling, then the MD symbol shall also be accompanied by adjacent explanatory text or be explained in an accompanying symbols glossary.  As the MD symbol isn't a U.S. requirement, the presence of the MD symbol can unnecessarily complicate the U.S labeling, especially if the MD symbol is on the shipper box.  This is because of FDA's very liberal interpretation of its statutory definitions for 'label' and 'labeling' and the statutory labeling term "accompanying" which causes such information to become regulated labeling information even if placed on an over-pack shipper.  If one chooses to place such information on the over-pack shipper, then that content and artwork must then come under document/design controls.  Accordingly, so as not to overcomplicate and bloat the firm's regulatory/QMS mechanisms, I would avoid putting such information on the over-pack shipper.

• Regarding Europe, put simply, the MD symbol is definitely required (i.e., it's not optional) for medical devices.  Specifically, it shall appear on the "label".  This is due to the combination of GSPR 23.1(h) and 23.2(q).  This was confirmed to me by the European Commission.  Yet my understanding is that the MDR's definition for "label" doesn't generally include an over-pack shipper box.  For example, we have a hint of that principle over in the UDI section, where the UDI (a critically-important label element) isn't required to be on the shipper.  I have not heard of a scenario where products were held by European customs because an over-pack shipper lacked the MD symbol.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Dec-2023 15:07
From: Robert Anglin
Subject: MD Symbol purpose

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

------------------------------
Robert Anglin RAC
VP, Quality & Regulatory
Minnesota Medical Technologies
Stewartville MN
United States
------------------------------

Hello Edward, thanks for your follow-up question.

As you know, Annex I.23.1(h) states that, where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols, and that any symbol or identification colour used shall conform to the harmonised standards or CS.  Consequently, for practical intents and purposes regarding the MD symbol, it is necessary for stakeholders to determine what is actually meant by "where appropriate".

I consider "where appropriate" to be subject to interpretation and intended to give a reasonable measure of flexibility.  Yet when I pressed the Commission to expand specifically on when the MD symbol is appropriate vs. when it is not appropriate for a medical device, the Commission's Directorate-General for Health and Food Safety informed me that, "...when an internationally recognised symbol is available and cited by a harmonised standard, its use should be considered as appropriate. This is the case for the symbol MD, identifying that the device is a medical device...".

Accordingly, to establish a corresponding regulatory compliance strategy that is coherent and sustainable, I have since advised that, for practical intents and purposes, the MD symbol is definitely required pursuant to my preceding post above.  Indeed, disputing this could quickly become a burdensome and costly compliance decision if/when regulators like Notified Bodies, Competent Authorities and/or the Directorate-General for Health and Food Safety won't budge on this interpretation.

Yet such Commission interpretations are not legally binding because only national courts, and ultimately the Court of Justice of the European Union, can give binding interpretations of European Union law.  But do we really want to pursue such burdensome legal channels in order to avoid conceding that the MD symbol is required per my preceding parameters and per the Directorate-General's interpretation?  I expect that most readers would neither want to, nor need to, go that costly legal route.  In that case again, put simply, the MD symbol is definitely required (i.e., it's not optional) for medical devices placed on the market in Europe's Union.

As a bit of an aside, yet still germane here, we've seen the Commission previously take the same kind of inflexible approach regarding the Union MDR's "where appropriate" vernacular.  Specifically, where the MDCG (2020-13) questionably asserts that clinical data are always required for all devices in conflict with Article 61(10) which instead provides a clear provision for waiver of clinical data for certain devices.  The clinical data/evaluation topic warrants an entire separate discussion(s) not appropriate for this thread; but it shows the Commission's current propensity to seemingly dismiss the flexibility that was once intended for "where appropriate".

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 08-Jan-2024 06:30
From: Edward Ball
Subject: MD Symbol purpose

Hi Kevin, I'd be interested to understand what the Commission actually confirmed for you. Practically, I agree that using the MD symbol is the way to go for EU bound devices but I am struggling with the 'definitely required' piece.

I agree that if a symbol is being used to identify the product as a medical device in the EU, then the MD symbol is given in the harmonised EN standard and thus is 'required' as per GSPR 23.1 (h). But if a symbol is not being used, then there is no requirement in the MDR that says a symbol must be used. I acknowledge that in most cases, products bound for the EU will be going to multiple markets and thus will require multiple languages, so the use of a symbol instead of said identification as a medical device in multiple languages is more logical. But if only one language is needed, it is feasible to use text only and not replace with a symbol. I suspect only a court of law could ultimately decide on the validity of a manufacturer's rationale for what was deemed 'appropriate' in meeting GSPR 23.1 (h), although it is highly unlikely we'd ever get that 'truth' rather the acceptance of the interpretation by all parties during the conformity assessment rather than taking legal action.

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 05-Jan-2024 14:35
From: Kevin Randall
Subject: MD Symbol purpose

Different jurisdictions approach the MD symbol differently; thus it is necessary to assure we have given account for each jurisdiction.  For example,

• If the MD symbol is present on U.S. device labeling, then the MD symbol shall also be accompanied by adjacent explanatory text or be explained in an accompanying symbols glossary.  As the MD symbol isn't a U.S. requirement, the presence of the MD symbol can unnecessarily complicate the U.S labeling, especially if the MD symbol is on the shipper box.  This is because of FDA's very liberal interpretation of its statutory definitions for 'label' and 'labeling' and the statutory labeling term "accompanying" which causes such information to become regulated labeling information even if placed on an over-pack shipper.  If one chooses to place such information on the over-pack shipper, then that content and artwork must then come under document/design controls.  Accordingly, so as not to overcomplicate and bloat the firm's regulatory/QMS mechanisms, I would avoid putting such information on the over-pack shipper.

• Regarding Europe, put simply, the MD symbol is definitely required (i.e., it's not optional) for medical devices.  Specifically, it shall appear on the "label".  This is due to the combination of GSPR 23.1(h) and 23.2(q).  This was confirmed to me by the European Commission.  Yet my understanding is that the MDR's definition for "label" doesn't generally include an over-pack shipper box.  For example, we have a hint of that principle over in the UDI section, where the UDI (a critically-important label element) isn't required to be on the shipper.  I have not heard of a scenario where products were held by European customs because an over-pack shipper lacked the MD symbol.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 19-Dec-2023 15:07
From: Robert Anglin
Subject: MD Symbol purpose

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?

------------------------------
Robert Anglin RAC
VP, Quality & Regulatory
Minnesota Medical Technologies
Stewartville MN
United States
------------------------------

What is the purpose of the MD symbol which is now required on Medical Device labeling?  How is it used in the real world?  We have added the symbol to our device labeling, including the shipper box (which is an over-pack and not the sales unit).  An EU distributor has said that the MD symbol is not required on the shipper box.  I had assumed that the symbol was needed by EU customs when receiving devices into the EU.  If not required, is there a down-side to have the MD symbol on the shipper box?