Does marketing company require CE mark if manufacturer has CE mark on product?

[Tim Wight]

Dear colleagues,

We have a scenario in which we could use some input and guidance:

1. "Company A" is located in the US. They have a CE mark for a sterile set of products.
2. "Company A" wishes to market under "Brand X" in the EU.
3. "Company B" is the manufacturer in India that has a CE Mark for the devices.
4. These devices will be either class Ia or IIa sterile in the EU.

Under MDR, can "Company A" market the devices under "Brand X" using the "Company B" CE mark and technical file under a documented quality agreement? If so, how does the label need to be structured? It is our suspicion that this arrangement won't be able to be done this way and that "Company A" will need to get their own CE mark. Thoughts?

 

[Ed Panek]

I would start with the MDR Label requirements. Labels require the Manufacturer and Authorized rep on labels I think. Also consider how eudamed will handle the economic operators.

Other than that is Company A the designer of the device? What do they do? If they are similar to a distributor or the like relabelling is acceptable as long as the label has the man of record and Auth Rep listed.

 

[Tim Wight]

Thank you for your reply. In answer to your questions:

Company A is the designer and distributor. They would like to add their own brand name without needing to accept the obligations of a manufacturer (ie obtain their own CE mark for the device). It's our view that would not be necessary if they are able to establish an agreement with the manufacturer regarding the packaging, all of the parties are identified on the label, and the integrity of the product is not compromised if repackaging is necessary.

Do you concur?

 

[Ronen E]

The above is a little confusing for me, so rather than trying to accurately understand "who does what" in this case, let me try and state some basics that seem relevant.

In MDR terms "Manufacturer" is the entity that bears the regulatory responsibility. Who physically makes the device (and where) is less relevant than the name on the device label (if more than one entity is there, it must be very clear who is the designated Manufacturer). Who the Manufacturer is is a matter of a conscious decision and it has serious ramifications.

If the Manufacturer on the label is different from what was previously cleared, or if any significant change to the label is made (e.g. the device name is changed), a "new CE mark" is required. More accurately, a new clearance process is required.

New branding or new packaging usually means taking full responsibility - it's a new product, regardless of the level of similarity to an existing/cleared one. The existing test data may be leveraged though (through reuse, not through a blanket pass), to a varying extent.

 

[levatorsuperioris]

For the Original OEM PLM relationship under the MDR, the PLM is required to have complete and current access to the technical file... This is not simply proven with a quality agreement, your NB will likely require you to prove you can get it immediately and completely... What you describe is one of the biggest changes to the MDD-MDR transition.

 

[Junn1992]

If you want the product to bear the brand name of company A, then company A is the manufacturer under the MDR.

If you want company A to sell the product only, company A is considered a distributor, but it CANNOT have its brand on the product. The product brand will have to be held by the company with the CE mark, which in this case is your OEM.

Definition from the MDR:
(30)‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

There you go.