Discontinuing using an Authorized Representative - CE Mark Labeling Requirements

Hello,

A client of mine would like to discontinue using their authorized representative. After years of trying, they still have not found a distributor for the EU and do not want to continue paying for the authorized rep. The problem is that they have a CE mark and the authorized rep's name on their labels, IFU's, etc. If they are not selling products in the EU, is it a problem if the authorized rep is still on the label? Do they need to remove this information from the label to continue selling the products domestically, in Latin America and Asia?

Thank you for your assistance.

A number of non-EC/EEFA countries constructively rely on the CE Mark as regulatorily significant. A company that has had a CE certificate and is in effect terminating that certificate by ceasing to meet the required conditions, certainly should remove the CE Mark from their labels ASAP.

Specific conditions applicable to the transition might be established in the contract between the manufacturer and their NB. Other conditions, specifically applicable to the particular posed question, might exist in the contract with the Authorized Representative.

In our case, we are in the US and have stopped selling our monitor in the EU because we are not 60601-1 3rd edition compliant, but would like to continue to support customers there by repairing their units, replacing accessories, etc.

We are considering not renewing with our Authorized Rep. We cannot supply the info they request anyway since the unit will not pass the updated standard, and we are maybe two years away from introducing anything in the EU.

Without an AR can we still support our EU customers? It seems we would have a problem shipping a repaired unit back into the EU with the AR's name on the back but without them acting as our AR.

For a company with no physical presence in the EU, no Authorized Representative = no valid CE Mark.

If they are not selling products in the EU, is it a problem if the authorized rep is still on the label? Do they need to remove this information from the label to continue selling the products domestically, in Latin America and Asia?

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The simple thing you can do is to have a label that is different for Latin America and Asia. Also check in both these markets if they still want to see the CE mark on your product for assurance purpose rather than legal. If so, then you are better in keeping the CE mark and the EU rep address on the label.

NT Bregman said:

Hello,

A client of mine would like to discontinue using their authorized representative. After years of trying, they still have not found a distributor for the EU and do not want to continue paying for the authorized rep. The problem is that they have a CE mark and the authorized rep's name on their labels, IFU's, etc. If they are not selling products in the EU, is it a problem if the authorized rep is still on the label? Do they need to remove this information from the label to continue selling the products domestically, in Latin America and Asia?

Thank you for your assistance.

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1. IMO if they discontinue their engagement with the EC rep they should obtain that rep's agreement if they want to continue using its name and details in their labeling (regardless of where they sell).

2. If they sell outside the EC, they should verify that application of the CE mark to the labeling (without actually being eligible) is not against the target countries' legislation. Some countries allow additional labeling content as long as their own minimum labeling-content requirements are met, and the mandatory content is not obscured / overshadowed by that additional content.

3. As MIREGMGR noted, if the target countries rely on the CE mark status for their own regulatory marketing clearance, continuing to apply the CE mark (whilst marketing in such countries) without actually being eligible may breach those countries terms of marketing clearance.

craiglab said:

In our case, we are in the US and have stopped selling our monitor in the EU because we are not 60601-1 3rd edition compliant, but would like to continue to support customers there by repairing their units, replacing accessories, etc.

We are considering not renewing with our Authorized Rep. We cannot supply the info they request anyway since the unit will not pass the updated standard, and we are maybe two years away from introducing anything in the EU.

Without an AR can we still support our EU customers? It seems we would have a problem shipping a repaired unit back into the EU with the AR's name on the back but without them acting as our AR.

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Hi,

The situation you describe is complex. "Continue to support customers" is not a clear-enough terminology to make decisions by. Repair of units already on the market and "replacing accessories" (= supply of new accessory units, if I got it right) are quite different from a regulatory perspective. Requirements applying to "etc." depend on the details of that "etc.".

As MIREGMGR noted, if you don't have a registered place of business in the EC (in simple words, an EC branch or office) and you don't have an EC rep, you are not eligible for CE marking (MDD article 14, s. 2). So if you go forward and discontinue the representation, the question should be "what are you still allowed to do when you're not eligible for the CE mark any more?"

Supply of new accessory units would (in my understanding) be regulated just as the supply of new device units. Therefore, not being eligible to CE mark those new accessory units, you won't be allowed to supply them any more.

With repair of units already on the market, the situation is different. The MDD's article 17, s. 1 states that "Devices... must bear the CE marking of conformity when they are placed on the market." (emphasis added).

As detailed in the European Commission's interpretative document on PLACING ON THE MARKET OF MEDICAL DEVICES (https://ec.europa.eu/health/medical-devices/files/guide-stds-directives/placing_on_the_market_en.pdf), various Directives and Regulation define that "placing on the market" means "first making available..." and so on (emphasis added); so, placing a device back on the market (e.g. after a repair) is excluded from the scope. This is further clarified by The European Commission's Guide to the implementation of directives based on the New Approach and the Global Approach, on p. 16:

Products which have been repaired (for example following a defect), without changing the original performance, purpose or type, are not to be considered as new products according to New Approach directives. Thus, such products need not undergo conformity assessment... This applies even if the product has been temporarily exported to a third county for the repair operations... Thus, maintenance operations are basically excluded.

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and on p. 17:

Consumer products outside the field of application of New Approach directives and other Community legislation (for example... repaired products) come under the Directive on general product safety, where they are supplied in the course of commercial activity.

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With regards to shipping repaired units back to the EC market, bearing outdated EC rep details, I think that even if there's no regulatory issue, you should sort it with that EC rep first. If things get complicated, maybe consider modifying those details on the units coming in for repair, to state something like "Initially placed on the EC market under representation of..."; however, a written opinion from your NB would probably be the safest measure.

Cheers,
Ronen.

With an item of equipment that's no longer eligible for the CE Mark but is marked with it, bringing it out of the EU for service and then trying to ship it back into the EU seems to be just asking for trouble. Surely the cost and complexity of documenting to everyone's satisfaction that the unit that left is exactly the same as the unit that's returned, and that the CE Mark on the unit was valid when applied and shouldn't be re-evaluated upon re-entry, would be more trouble than the economic value of the process.

It might be more straightforward to ship the needed parts and information to a contract repair depot within the EU and have them do the work.

MIREGMGR said:

With an item of equipment that's no longer eligible for the CE Mark but is marked with it, bringing it out of the EU for service and then trying to ship it back into the EU seems to be just asking for trouble. Surely the cost and complexity of documenting to everyone's satisfaction that the unit that left is exactly the same as the unit that's returned, and that the CE Mark on the unit was valid when applied and shouldn't be re-evaluated upon re-entry, would be more trouble than the economic value of the process.

It might be more straightforward to ship the needed parts and information to a contract repair depot within the EU and have them do the work.

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I mostly agree but not sure I understand what you mean by "the CE Mark on the unit... shouldn't be re-evaluated upon re-entry". Could you please describe the evaluation (or re-evaluation) process, if you are aware of anything beyond just observing that the unit bears a legible CE mark and the associated essentials (i.e. EC rep details, NB number etc.)?

Thanks,
Ronen.

My understanding is that Customs folks may check for a CE Mark to determine entry eligibility, then look up the product in the registration database. As far as I know, one of the responsibilities of Authorized Representatives is to enter their represented manufacturers' products into the database, and maintain the currency of those entries. Thus my understanding is that a terminated Authorized Representative relationship results in a database entry that certain products are no longer represented by that company. If no other company has re-entered them into the database, I'd expect the Customs folks to hold the shipment while they enquire, and to take some sort of adverse action if they establish that an applied CE Mark is not valid.

That's roughly parallel to how US Customs and US FDA handle a check for valid listing of a medical device coming into the US, for instance.