Regulatory Open Forum

Stating that a standard is harmonized without stating the version of the standard is not correct. Many harmonized standards are now obsolete.

Harmonization is relative to a directive or regulation. It is not an attribute of the standard, but of directive or regulation. One cannot look at a standard and determine whether or not it is harmonized to any directive or regulation.

In terms of the MDD, the correct statement is EN ISO 15223-1:2016 is harmonized to the MDD.

The second question is whether the harmonized standard is the current standard. The current standard is EN ISO 15223-1:2016. However, EN ISO 15223-1:2016/prA1 is "Under Enquiry" and prEN ISO 15223-1 rev is "Under Approval".

The current standard and standard harmonized to the MDD are the same. This is good!

The original question, however, did not ask about the MDD but about the MDR. There are no standards harmonized to the MDR.

The requirement in EU-MDR Annex I(23.2)(q) is "an indication that the device is a medical device". This does not require a symbol, but a symbol does not require translation. Other indications may require translation.

There is a suitable symbol in a MedTech Europe guidance document "Use of Symbols to Indicate Compliance with the MDR" December 2019 Version 2.0. I've attached the document.

EU-MDR Annex (23.1)(h) requires that, when appropriate, "the information supplied by the manufacturer shall take the form of internationally recognized symbols". It provides two options:
A harmonized standard
A common specification

Unfortunately, neither exists for the EU-MDR.

However, there is a third option. "In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

There is good news and bad news here.

Good News: Feel free to use the symbol from the MedTech Europe guidance document provided you describe the symbol in the documentation supplied.

Bad News: Because the EU-MDR does not have any harmonized standards or common specifications, you must describe every symbol used.

Stating that a standard is harmonized without stating the version of the standard is not correct. Many harmonized standards are now obsolete.

Harmonization is relative to a directive or regulation. It is not an attribute of the standard, but of directive or regulation. One cannot look at a standard and determine whether or not it is harmonized to any directive or regulation.

In terms of the MDD, the correct statement is EN ISO 15223-1:2016 is harmonized to the MDD.

The second question is whether the harmonized standard is the current standard. The current standard is EN ISO 15223-1:2016. However, EN ISO 15223-1:2016/prA1 is "Under Enquiry" and prEN ISO 15223-1 rev is "Under Approval".

The current standard and standard harmonized to the MDD are the same. This is good!

The original question, however, did not ask about the MDD but about the MDR. There are no standards harmonized to the MDR.

The requirement in EU-MDR Annex I(23.2)(q) is "an indication that the device is a medical device". This does not require a symbol, but a symbol does not require translation. Other indications may require translation.

There is a suitable symbol in a MedTech Europe guidance document "Use of Symbols to Indicate Compliance with the MDR" December 2019 Version 2.0. I've attached the document.

EU-MDR Annex (23.1)(h) requires that, when appropriate, "the information supplied by the manufacturer shall take the form of internationally recognized symbols". It provides two options:
A harmonized standard
A common specification

Unfortunately, neither exists for the EU-MDR.

However, there is a third option. "In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

There is good news and bad news here.

Good News: Feel free to use the symbol from the MedTech Europe guidance document provided you describe the symbol in the documentation supplied.

Bad News: Because the EU-MDR does not have any harmonized standards or common specifications, you must describe every symbol used.

I am hoping you can advise on the packaging level(s) where the MD symbol (or other indication that the product is a medical device) is required. For example, consider the case where there are six devices contained in an inner box, which is the lowest saleable unit. And a master carton containing 4 inner boxes. The EU MDR definition of a label includes the packaging of multiple devices, which would seem to indicate the MD symbol could be on the inner box only, but with this interpretation, the product identification, additional symbols, and the Authorized Rep information could also be on the inner box and not on the device itself. We have always included this information on the actual device labels. Could you please comment on the lowest level of packaging where the MD symbol and the AR information would be required? Is there a guidance which is more specific regarding the labeling requirements for the various packaging levels? Thanks.

Stating that a standard is harmonized without stating the version of the standard is not correct. Many harmonized standards are now obsolete.

Harmonization is relative to a directive or regulation. It is not an attribute of the standard, but of directive or regulation. One cannot look at a standard and determine whether or not it is harmonized to any directive or regulation.

In terms of the MDD, the correct statement is EN ISO 15223-1:2016 is harmonized to the MDD.

The second question is whether the harmonized standard is the current standard. The current standard is EN ISO 15223-1:2016. However, EN ISO 15223-1:2016/prA1 is "Under Enquiry" and prEN ISO 15223-1 rev is "Under Approval".

The current standard and standard harmonized to the MDD are the same. This is good!

The original question, however, did not ask about the MDD but about the MDR. There are no standards harmonized to the MDR.

The requirement in EU-MDR Annex I(23.2)(q) is "an indication that the device is a medical device". This does not require a symbol, but a symbol does not require translation. Other indications may require translation.

There is a suitable symbol in a MedTech Europe guidance document "Use of Symbols to Indicate Compliance with the MDR" December 2019 Version 2.0. I've attached the document.

EU-MDR Annex (23.1)(h) requires that, when appropriate, "the information supplied by the manufacturer shall take the form of internationally recognized symbols". It provides two options:
A harmonized standard
A common specification

Unfortunately, neither exists for the EU-MDR.

However, there is a third option. "In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

There is good news and bad news here.

Good News: Feel free to use the symbol from the MedTech Europe guidance document provided you describe the symbol in the documentation supplied.

Bad News: Because the EU-MDR does not have any harmonized standards or common specifications, you must describe every symbol used.

In terms of the medical device indication, I don't know of any regulation that defines the location except on the label.

Art. 2(13) defines the label as "the written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices".

In practical terms, consider that there is information communicated to somebody. Determine who should receive the information. (There is a similar process in ISO 14971:2007 Annex J, so I would apply that approach. One might even consider the medical device indication as information for safety (but it is a stretch).

A good rule of thumb considers other information for communication. In this case, the key is the UDI-DI. Wherever you have a UDI-DI at any packaging level, pair it with the medical device indication.

For the authorized representative, go back to the definition of a label. I'm not sure who would use the information, but my sense is that it not the users of the UDI-DI.

I am hoping you can advise on the packaging level(s) where the MD symbol (or other indication that the product is a medical device) is required. For example, consider the case where there are six devices contained in an inner box, which is the lowest saleable unit. And a master carton containing 4 inner boxes. The EU MDR definition of a label includes the packaging of multiple devices, which would seem to indicate the MD symbol could be on the inner box only, but with this interpretation, the product identification, additional symbols, and the Authorized Rep information could also be on the inner box and not on the device itself. We have always included this information on the actual device labels. Could you please comment on the lowest level of packaging where the MD symbol and the AR information would be required? Is there a guidance which is more specific regarding the labeling requirements for the various packaging levels? Thanks.

Stating that a standard is harmonized without stating the version of the standard is not correct. Many harmonized standards are now obsolete.

Harmonization is relative to a directive or regulation. It is not an attribute of the standard, but of directive or regulation. One cannot look at a standard and determine whether or not it is harmonized to any directive or regulation.

In terms of the MDD, the correct statement is EN ISO 15223-1:2016 is harmonized to the MDD.

The second question is whether the harmonized standard is the current standard. The current standard is EN ISO 15223-1:2016. However, EN ISO 15223-1:2016/prA1 is "Under Enquiry" and prEN ISO 15223-1 rev is "Under Approval".

The current standard and standard harmonized to the MDD are the same. This is good!

The original question, however, did not ask about the MDD but about the MDR. There are no standards harmonized to the MDR.

The requirement in EU-MDR Annex I(23.2)(q) is "an indication that the device is a medical device". This does not require a symbol, but a symbol does not require translation. Other indications may require translation.

There is a suitable symbol in a MedTech Europe guidance document "Use of Symbols to Indicate Compliance with the MDR" December 2019 Version 2.0. I've attached the document.

EU-MDR Annex (23.1)(h) requires that, when appropriate, "the information supplied by the manufacturer shall take the form of internationally recognized symbols". It provides two options:
A harmonized standard
A common specification

Unfortunately, neither exists for the EU-MDR.

However, there is a third option. "In areas for which no harmonized standards or CS exist, the symbols and colors shall be described in the documentation supplied with the device".

There is good news and bad news here.

Good News: Feel free to use the symbol from the MedTech Europe guidance document provided you describe the symbol in the documentation supplied.

Bad News: Because the EU-MDR does not have any harmonized standards or common specifications, you must describe every symbol used.

There is potential problem with this strategy.

You say, "until a symbol can be approved for both EU and FDA requirements". For the EU a symbol must be in either a harmonized standard or common specification. (One could use a symbol defined in the accompanying documentation.)

Given the current state of affairs, the EU-MDR will never have a harmonized standard. It is unlikely, in my view, that the EU will create a common specification to fill the gap created by lack of a harmonized standard.

I think we should be very careful about asserting that there are no standards harmonized to Regulation 2017/745 (the EU MDR), or that the EU MDR will never have a harmonized standard.  Reliance on harmonized standards is a deeply established and longstanding paradigm in Europe that extends beyond just the medical device sector.  The notion that the EU MDR leaves us suddenly barren of harmonized standardization is a notion that is fundamentally contrary to Europe's wider legislative infrastructure.

Accordingly, be sure not to overlook the final paragraph of EU MDR Article 122 stating that references to the repealed Directives (i.e., 93/42/EEC and 90/385/EEC) shall be understood as references to the EU MDR and shall be read in accordance with the correlation table laid down in EU MDR Annex XVII.  Although Annex XVII is far from perfect, and although it moreover will certainly leave some unanswered questions in areas where the EU MDR contains fundamentally new content with respect to Directives 93/42/EEC and 90/385/EEC, such a predicament is certainly far more manageable, and astronomically different, than the notion that we have no harmonized standardization at all under Regulation 2017/745.

There is potential problem with this strategy.

You say, "until a symbol can be approved for both EU and FDA requirements". For the EU a symbol must be in either a harmonized standard or common specification. (One could use a symbol defined in the accompanying documentation.)

Given the current state of affairs, the EU-MDR will never have a harmonized standard. It is unlikely, in my view, that the EU will create a common specification to fill the gap created by lack of a harmonized standard.

I think we should be very careful about asserting that there are no standards harmonized to Regulation 2017/745 (the EU MDR), or that the EU MDR will never have a harmonized standard.  Reliance on harmonized standards is a deeply established and longstanding paradigm in Europe that extends beyond just the medical device sector.  The notion that the EU MDR leaves us suddenly barren of harmonized standardization is a notion that is fundamentally contrary to Europe's wider legislative infrastructure.

Accordingly, be sure not to overlook the final paragraph of EU MDR Article 122 stating that references to the repealed Directives (i.e., 93/42/EEC and 90/385/EEC) shall be understood as references to the EU MDR and shall be read in accordance with the correlation table laid down in EU MDR Annex XVII.  Although Annex XVII is far from perfect, and although it moreover will certainly leave some unanswered questions in areas where the EU MDR contains fundamentally new content with respect to Directives 93/42/EEC and 90/385/EEC, such a predicament is certainly far more manageable, and astronomically different, than the notion that we have no harmonized standardization at all under Regulation 2017/745.

There is potential problem with this strategy.

You say, "until a symbol can be approved for both EU and FDA requirements". For the EU a symbol must be in either a harmonized standard or common specification. (One could use a symbol defined in the accompanying documentation.)

Given the current state of affairs, the EU-MDR will never have a harmonized standard. It is unlikely, in my view, that the EU will create a common specification to fill the gap created by lack of a harmonized standard.