Discontinuing using an Authorized Representative - CE Mark Labeling Requirements

[Ronen E]

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.

Thanks for that. do you have a pointer to any legislative / regulatory / administrative documentation that prescribes such process (in the EC)?

EC Authorized Representatives are generally only required to register class I devices and systems / procedure packs, with their CAs. Apparently they are also required to report changes relating to the details that the MDD requires them to provide during initial registration; however, I'm not sure regarding their formal obligations when their contract with a specific client is discontinued / expires, and the exact procedures to be followed in such cases.

 

[MIREGMGR]

do you have a pointer to any legislative / regulatory / administrative documentation that prescribes such process (in the EC)?

No, I don't. I've been told in the past by a source that I regard as sufficiently knowledgable that that's the working process, and I've never researched it further as the description seems coherent with my knowledge of the US process, for which I have direct knowledge.

 

[somashekar]

If you have a good EU AR service contract agreement established, the method for discontinuing will be mentioned within that, which you can follow.
Here is such an extract for you. Have a good look into your AR agreement established...
§ 6
Duration and Cancellation of the Contract
1. Unless otherwise earlier terminated as herein provided, this Contract will have a term of
five (5) years, commencing from the date of this Contract as contained in the first
paragraph of this Contract. The contract will extend automatically for another year
unless one of the parties cancels it by ninety (90) day’s prior written notice.
2. This Contract may be terminated at any time by either the Manufacturer or AR, if
there has been a breach of this Contract by the other party that is not cured within ten
(10) days after the breaching party has been notified in writing of the breach and the
other party’s intent to terminate the Contract.
3. In the event that liability coverage required to be obtained and maintained by the
Manufacturer becomes invalid, terminated or is withdrawn and in the event such
insurance is not replaced or reinstated within five (5) days of such invalidity, termination
or withdrawal, then and in both such events, AR may terminate this Contract without
further notice.
4. Upon the cancellation of this Contract the Manufacturer agrees not to place any devices
on the market with the name and address of AR. The name and address shall be
removed from all device(s), packaging, labeling, Instructions-for-Use, advertising material and the Declaration of Conformity.
5. Upon termination of this Contract, AR will immediately notify the relevant EU
authorities that AR is no longer the “Authorized Representative” of the Manufacturer.
Upon said notification, AR shall no longer be responsible or in any way liable for the
devices of the Manufacturer sold in the EU, including devices from the Manufacturer that
still bear the AR Name and Address in any form, and devices of the Manufacturer
that are still in use or circulation within the EU, after the date of termination of this
contract.
6. Notwithstanding the above, the obligations named in § 4 No. 2 of this contract shall
extend at least five years after termination/cancellation of the contract.

§ 4
Responsibilities of the Manufacturer

2. In the event that any European authority or national authority or any binding court
decision demands from AR access to the Manufacturer’s technical documentation
(device-master-files) according to the applicable Annex of the MDD 93/42/EEC or any
other applicable national or European law, for devices sold in the EU, the Manufacturer
agrees to provide such documentation to AR within three (3) days of the
Manufacturer’s receipt of written notification from AR.

 

[jradford]

I have a similar question. What if your AR goes out of buisness. Not bought out by someone else, but just disolves. We are in the process of signing our distributor as our AR, but what responsibilities would be on the former AR, if any? Do the customers need to be notified of the change to the AR?

 

[Ronen E]

Certainly the customers would be "notified" because AR details must appear on the labeling.

 

[CharlieUK]

If you are shipping a unit out of the EU for repair and then returning it for repair, I would recommend;
- ensuring that all paperwork makes it clear that initial export is only temporary for repair and that return documentation makes it clear that it is being returned after repair.
- not changing the labelling - you are not placing the unit on the market, just returning it after repair. You should be careful to try and avoid any "upgrade" at same time so that product is not changed.

The Authorised Representative is there as a contact point for enforcement authorities in case of a reported problem, not as a contact point for customs. If the paperwork is clear, and device has only been exported from EU and returned following repair, customs shouldn't have an issue.

 

[drewsky1]

We have notified our NB that we were discontintuing some of our product lines in EU and would be removing the CE mark on the labeling by end of the year. We feel at this time, we may not be able to meet that committed date. What is the impact if the CE mark is still on the labeling for product that is sold elsewhere (US, other International Mkts, asia, Japan, etc) after the date we committed to the NB? Any legal risk, etc?

Thanks

 

[MIREGMGR]

What is the impact if the CE mark is still on the labeling for product that is sold elsewhere (US, other International Mkts, asia, Japan, etc) after the date we committed to the NB?

Assuming that your product does in fact not find its way into EU, the primary issue will be with other regulatory jurisdictions within which you or the local importer/distributor has referenced the CE status to obtain clearance for that country. I'd think you should survey all of your international markets to identify any for which CE has been referenced, and initiate a new non-CE clearance process for them.

If you distribute into Australia, for instance, there will be an issue.

 

[CharlieUK]

........ What is the impact if the CE mark is still on the labeling for product that is sold elsewhere (US, other International Mkts, asia, Japan, etc) after the date we committed to the NB? Any legal risk, etc?

You must remove the CE mark

The main Europa website on CE marking (http: // ec. europa. eu/enterprise/policies/single-market-goods/cemarking/about-ce-marking/index_en.htm - DEAD 404 LINK UNLINKED) opens with the phrase

"The CE marking indicates a product?s compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking,......

It doesn't matter where you intend to market the equipment, a CE mark says that the product complies, if it doesn't, you should remove the CE mark.

 

[drewsky1]

Thank you for your responses. Yes we have previously notified all other international regulatory juristications about the Discontinuation of these products and have received feedback.

We believe the products do complies, however will take this into consideration.