Placement of cosmetic products on EU market as medical devices

[vondecko]

Hi, I am hoping someone could advice me which legal set-up would help in the following situation. Our (EU based) company is a distributor of cosmetics manufactured in a third coutry (New Zealand). Recently we managed to have the products acknowledged as class IIa medical devices in a borderline proceedings by Slovak medicines agency. Based on that we would like to arrange for CE certification and place the products on the market as medical devices under our own name.

However, apparently we are not in the position of the manufacturer, which is problem in terms of conformity assessment procedure. Our idea is to establish an OBL/OEM manufacturer concept, i.e. to become an virtual manufacturer and enter into respective contracts with our suppliers (the factual manufacturer from New Zealand and local company which is repackaging and bottling the products). But we are not sure if OEM/OBL manufacturer concept is feasible for us given that the imported products are not manufactured as medical devices but as cosmetics. Therefore the NZ manufcaturer has no documentation and QMS implemented as required under EU MD regulation. Is there any way to overcome this and launch the products on the EU market as medical devices anyway?

Thank you for any ideas

 

[supadrai]

There is no valid way to meet the requirements of a QMS, unless you actually have a QMS.

This isn't a theoretical statement or moral judgment (I'll reserve those), it's very practical. You have no way to compile the technical file required to support the registrations and you also need to bring a Notified Body on board, what Notified Body will support you? None. Even as the legal manufacturer (as you say virtual manufacturer) somewhere down the line, the QMS must be verified by a third party.

Also, as an EU based company, if you just package with the CE mark and then start shipping, you will be taking a risk that will put your company's survival on the line, and that risk will be realized. Just one example, our former JV partner got nailed in Italy for having a CE mark that was the wrong dimensions - and this was not visible to the naked eye. The fine was something like 1,000 EU per violation (i.e. per package), in the end they didn't have to pay that much because their recall was effective and other mitigating factors. But your violation would likely be viewed as be intentional and fraudulent, so you shouldn't expect any leniency.

Your management needs to go back and reassess. If competition is so strong that the margin on this product is so thin and the volume so small, that you can't adjust the unit-pricing to cover your supplier's investment in a QMS, then I would question whether the business was ever even viable.

 

[vondecko]

Thank you very much for your insight!

We definitely don't want to cross any legal lines and certainly cannot afford it.... we were under impression that QMS could be covered by our EU subcontractor who is responsible only for repackaging, bottling at this time. But since this company complies with ISO 13485, it could also do testing of the imported product and ensure their compliance with MD requirements in future.

From our understanding, conformity assessment can be based on certification of the type (annex VI od MD Directive). If we are able to verify whether the supplied products match the certified type (i. e. to control the outcome of manufacturing process), wouldn't it be sufficient in terms of QMS? Or the factual (NZ) manufacturer of the products would still need to implement QMS?

As for the technical documentation, our consultant says it can be prepared on basis of information provided by the manufacturer. There is full transparency between us. However, since we are new in medical devices area I get that our ideas may be a bit naive.... I will be happy if you can share your opinion on this. We are finalizing clinical evaluation of the products and invested many resources into borderline proceedings to prove our products actually are medical devices. It would be disappointing if we couldn't pursue are business opportunities because of not being able to achieve the CE marking.

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