Medical Device OEM, OBL and Private Labeling Questions

[pccaro]

Hello All,

After following this site, I hope there is some one that have an answer for me. My questions is in regard to OEM, OLB and Private labeling.

I'm new in the regulatory area and I have a project to identify the best path to take to have foreign equipment labeled with our company name and logo, knowing that the equipment contain a CE mark.

Scenario 1.
My Company (B) buys equipment from company A (foreign company). Company A label their equipment with name and logo of Company B. Is this consider OBL or private label?

Scenario 2.
Company B buys equipment from Company A. Company B places label and logo to the equipment in USA. Company B re-sells these equipment in USA and Europe. I know we can use the same NB number if we work with the same Notify Body of Company A; however, what is the process/regulations for this? Who contacts the NB; Company A or B? what if, Company B decided to use a different NB? Does Company B is consider an OEM or OBL?

Scenario 3:

Company B buys equipment from Company A, but just re-sell them in USA and Europe? What are the requirements/regulations as Distributors?


Additional Questions:
What is the responsibility of an OBL in regards to the Technical File?
Does an OBL still require to have a Quality System in place?

I hope some one can help me with this. I apologize for too many questions, but I'm so confuse with OEM, OBL and private labeling. Thank you in advance for your support.

Regards,
Priscilla

 

[J0anne]

Scenario 1 - Company A is the manufacturer

Scenario 2 - Company B is the manufacturer and can change NB if they wish

Scenario 3 - I don't have the answer.

Additional questions - An OBL has the same responsibilities as a manufacturer and a technical file is a requirement.

 

[MIREGMGR]

In Scenario 2, note that Company A's relationship with their NB, and their placement of their CE Mark on the product version that they sell, are irrelevant to you. When you label your version of the product, the CE Mark you apply is yours, not theirs. Assuming that the products is Class I-s or above (because you mentioned that their CE Mark includes an NB identifying number), you must have your own CE certificate from your NB.

In Scenario 3, there are no requirements for you as a distributor, at least in regard to medical device regulations.

Does an OBL still require to have a Quality System in place?

Yes, encompassing all operations you perform.

 

[J0anne]

Scenario 3 - Check 3.4 of the attached document.

 

[MIREGMGR]

In Scenario 3, there are no requirements for you as a distributor, at least in regard to medical device regulations.

The document that Joanne provides is comprehensive.

I inferred from the original post though that the poster's company is located in USA. If so, and if they do business in Europe in typical ways, they may not be the Distributor for regulatory purposes in Europe. Instead they would be a US-based wholesaler, with one or more (usually) EU-located third parties being Distributors, and also Importers, for which the other discussion in Joanne's provided document would be relevant.

Within USA, distributors are not subject to most of the significant FDA requirements, i.e. no Registration, no Listing, no Pre Market approvals/notifications, no post market surveillance other than as an adjunct to the manufacturer.

 

[J0anne]

Miregmr, It wasn't my intention to infer there was any omission in your response and I don't believe you perceived it as such. It was just a case of adding additional info to my initial response.