Regulatory Open Forum

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?  

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?  

I am told the EU Legislation is Regulation (EU) 2019/1020.
I was also pointed to this link for additional information.

https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements

Still trying to get a better understanding before we start revising our labeling.
Our product is CE mark in accordance to the EMC directive.
Would it be acceptable if we just added the EU address of our EU company WITHOUT the EU/REP symbol to avoid confusion?
This way the outer package is compliant with the EU address?

Just wondering if anyone else has experience with this.
 

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?  

For a product that is not a medical device yet still is subject to the EMC Directive (2014/30/EU), it is important to remember that the EMC Directive does not mandate the use of an Authorised Representative. This remains true even if the Manufacturer (i.e., the operator under whose labeled name the product is being marketed) is established outside the Union.  But there is always an Importer whenever the Manufacturer is established outside the Union.

Also noteworthy is that Regulation (EU) 2019/1020 (the "Market Surveillance regulation") does not change the aforesaid optional Authorised Representative provision of the EMC Directive.  Indeed, the Market Surveillance regulation allows its economic operator market surveillance obligations to be met by either the Manufacturer, or the Importer (when the Manufacturer is not established in the Union), or a designated/mandated Authorised Representative (if any there may be), or even a fulfilment service provider in certain cases.

Europe's product traceability requirements demand that the product or its accompanying information indicate at least a) a single point of contact for the Manufacturer; and b) if there is an Importer, then the Importer's identification and contact information in addition to the Manufacturer's.

The aforesaid Manufacturer single point of contact may either be where the Manufacturer itself is established or instead it can be the Manufacturer's designated Authorised Representative (if any there may be).  Note that Europe's general rule is that only one single contact point for the Manufacturer is allowed on each product.  Nonetheless, the manufacturer can still include other addresses (such as that of the Authorised Representative) so long as it's clear which one is designated as the Manufacturer's single point of contact, and so long as the multiple addresses don't mislead the end-user and competent authorities about the place of manufacture.

Clarifiers like "manufactured by", "imported by", "represented by" (or their respective harmonized symbols) and "single contact point" can be used on the product or accompanying information to assure that the foregoing operator roles are made clear.

Hope this helps.

I am told the EU Legislation is Regulation (EU) 2019/1020.
I was also pointed to this link for additional information.

https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements

Still trying to get a better understanding before we start revising our labeling.
Our product is CE mark in accordance to the EMC directive.
Would it be acceptable if we just added the EU address of our EU company WITHOUT the EU/REP symbol to avoid confusion?
This way the outer package is compliant with the EU address?

Just wondering if anyone else has experience with this.
 

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?  

For a product that is not a medical device yet still is subject to the EMC Directive (2014/30/EU), it is important to remember that the EMC Directive does not mandate the use of an Authorised Representative. This remains true even if the Manufacturer (i.e., the operator under whose labeled name the product is being marketed) is established outside the Union.  But there is always an Importer whenever the Manufacturer is established outside the Union.

Also noteworthy is that Regulation (EU) 2019/1020 (the "Market Surveillance regulation") does not change the aforesaid optional Authorised Representative provision of the EMC Directive.  Indeed, the Market Surveillance regulation allows its economic operator market surveillance obligations to be met by either the Manufacturer, or the Importer (when the Manufacturer is not established in the Union), or a designated/mandated Authorised Representative (if any there may be), or even a fulfilment service provider in certain cases.

Europe's product traceability requirements demand that the product or its accompanying information indicate at least a) a single point of contact for the Manufacturer; and b) if there is an Importer, then the Importer's identification and contact information in addition to the Manufacturer's.

The aforesaid Manufacturer single point of contact may either be where the Manufacturer itself is established or instead it can be the Manufacturer's designated Authorised Representative (if any there may be).  Note that Europe's general rule is that only one single contact point for the Manufacturer is allowed on each product.  Nonetheless, the manufacturer can still include other addresses (such as that of the Authorised Representative) so long as it's clear which one is designated as the Manufacturer's single point of contact, and so long as the multiple addresses don't mislead the end-user and competent authorities about the place of manufacture.

Clarifiers like "manufactured by", "imported by", "represented by" (or their respective harmonized symbols) and "single contact point" can be used on the product or accompanying information to assure that the foregoing operator roles are made clear.

Hope this helps.

I am told the EU Legislation is Regulation (EU) 2019/1020.
I was also pointed to this link for additional information.

https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements

Still trying to get a better understanding before we start revising our labeling.
Our product is CE mark in accordance to the EMC directive.
Would it be acceptable if we just added the EU address of our EU company WITHOUT the EU/REP symbol to avoid confusion?
This way the outer package is compliant with the EU address?

Just wondering if anyone else has experience with this.
 

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?  

I am told the EU Legislation is Regulation (EU) 2019/1020.
I was also pointed to this link for additional information.

https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements

Still trying to get a better understanding before we start revising our labeling.
Our product is CE mark in accordance to the EMC directive.
Would it be acceptable if we just added the EU address of our EU company WITHOUT the EU/REP symbol to avoid confusion?
This way the outer package is compliant with the EU address?

Just wondering if anyone else has experience with this.
 

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?  

Start with the Market Surveillance Directive, 2019/1020. One of the goals is the ability of the market surveillance authorities to know the distribution chain of the products in the EU. Article 4(4) saus, "Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document".

Article 4(1) says, "Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product".

The directive has lists of the legislation, so you need to see which ones may apply to your product.

Annex I lists the EMC directive, which applies to your products. The EMC directive requires that you have an Authorized Representative. You should identify the AR "on the product or on its packaging, the parcel or an accompanying document".

While the regulation does not define accompanying document, I infer it could something like a commercial invoice, a pack slip, etc. In that case, you do not need to change the labels.

If it were me, however, I would add the Authorized Representative to the label and be done forever.

I am told the EU Legislation is Regulation (EU) 2019/1020.
I was also pointed to this link for additional information.

https://www.trade.gov/country-commercial-guides/eu-labelingmarking-requirements

Still trying to get a better understanding before we start revising our labeling.
Our product is CE mark in accordance to the EMC directive.
Would it be acceptable if we just added the EU address of our EU company WITHOUT the EU/REP symbol to avoid confusion?
This way the outer package is compliant with the EU address?

Just wondering if anyone else has experience with this.
 

Our International Logistics Mgr. (based in Switzerland) learned in 2021 the EU changed its legislation, therefore, if a US company (manufacturer & distributor) wants to import goods into the EU and sell these to his/her EU-customers the company needs to have an EU address.
This new legislation also has our logistics manager under the impression, the "liability" of these goods now falls on the new EU company. This makes sense....but........

We did establish an EU company with an EU address, however, the question regarding labeling has us confused. 

1. Does this new legislation's liability requirements require ALL EU companies (regardless what they sell) to label their goods with an EU REP? 
2. If the EU REP information is applied to the labeling (package and IFU) does this labeling cause confusion to the end user with respect to the regulatory assessment of the devices sold? 
3. If the current labeling identifies the manufacturers (US and/or other than EU) is this sufficient for the end user to report adverse events to the accountable party?
4. Are there different roles/responsibilities for EU Reps if the devices are not regulated by the EU MDR? Do we have to differentiate? IS there a way to differentiate this?