Any thoughts on a plan to get CE marked products from a one person company?

It is about a one person Dutch company who wants to sell medical devices under their own name (brand label). The OEM company in the UK holds an ISO 13485 certificate, a Full Quality Assurance certificate accoriding MDD Annex II, section 3.2 and a Design examination certificate according to MDD Annex II, section 4 for these products.

Has anyone experience with such constructions? What would you advise? I guess that there should be a technical / quality agreement between the private label company and the original manufacturer. Has anyone some examples of such contratcs?

Any help is appreciated.

Rob Udo

Any thoughts on a plan to get CE marked products from a one person company?

It is about a one person Dutch company who wants to sell medical devices under their own name (brand label). The OEM company in the UK holds an ISO 13485 certificate, a Full Quality Assurance certificate accoriding MDD Annex II, section 3.2 and a Design examination certificate according to MDD Annex II, section 4 for these products.

Has anyone experience with such constructions? What would you advise? I guess that there should be a technical / quality agreement between the private label company and the original manufacturer. Has anyone some examples of such contratcs?

Any help is appreciated.

Rob Udo
I have never heard of a construction like that :confused: Basically what I would do if I wanted to CE-mark it myself is, I would contact the OEM manufacturers NB and ask them what they would require for me to CE-mark the product. They already have the documentation on file, and know the Q-system of the manufacturer.

What class of product are we talking about?

On another thought, I would probably just have the OEM-manufacturer label it with a name of my choosing but let him CE-mark. It would be cheaper for all parts...

:D Hmmmmmm... one-person-company. Sounds great.

It is a class III bone replacement.

Actually nothing too strange in this, although one-man-bands are rare even in the medical device business which has companies of all sizes.

First-off, it wasn't actually clear to me if you were:
a) the one-man company seeking to buy OEM product
b) advising the one-company
c) a potential customer of the one-man company
d) something else

I wrote an article in Medical Device Technology magazine a while back (Jan/Feb 2005) - "Own-brand Labelling: A How-To Guide", which should hopefully answer your questions. I obviously can't attach copyright material here, but you can probably get a copy of that somewhere.

Since then a NB-MED guidance document on OEM/OBM arrangements has been drafted, as attached, but I am not sure of its current status as issuing it was reliant on first getting feedback from NBOG.

There are various template agreements around, a few professional authorised reps have their own versions, as do several "full-time OEMs". The law firm Cameron McKenna also created one that I have seen around the place.
You can of course design your own if you go through the MDD carefully enough.

Whatever agreement you end up with, I would definitely keep the technical and regulatory elements separate from the financial stuff.

Hope this helps!

We did some similar OBL (Private Label) certifications.

For a Class III product, it would be rather expensive.

The private labeler has to establish the same quality system as the OEM, then a OBL-Contract has to be signed and after that the notified body will apply the same Annex for the OBL, as the OEM has.

The interesting (and expensive) part will be the required AnnexII.4 Examination of the design of the product. But this is also doable.

The size of the OBL company does not matter (only for determination of the minimum required audit time).

And yes, we are following the NB-MED/2.5.5/Rec 5, although its a draft.

There is always a degree of hand-wringing when it comes to how much audit work the second Notified Body has to do.

On the one hand, there is a general understanding that Notified Bodies will accept each others' certificates unless there is evidence that there is a problem.

And aside from confirming a few things like labelling, the OEM/OBL agreement, and the Own Brand Labeller's QMS controls over regulatory, traceability etc etc, there shouldn't be too much for the second NB to do - after all the product has been fully assessed.

On the other hand, especially for Class III devices, few Notified Bodies want to blindly certify something they haven't looked at themselves.

SGS tends to go for either a truncated Technical File / Dossier Review or a full review, depending on the established history of both the OEM and OBL, and also depending on the perceived risk of the device. In terms of onsite audit, we would be highly unlikely to go to the OEM, but would go to the OBL unless this was an activity with which we already had confidence.

Finally, Own Brand Labellers are often sales organisations without a clue about quality systems or regulatory compliance. Often gets very interesting. :rolleyes:
(Though not as interesting as when I reject the OEM's Notified Body's certification. "By the way, that's a Class III drug-device..." :notme: )

Finally, Own Brand Labellers are often sales organisations without a clue about quality systems or regulatory compliance. Often gets very interesting. :rolleyes:
(Though not as interesting as when I reject the OEM's Notified Body's certification. "By the way, that's a Class III drug-device..." :notme: )

IMHO the most interesting OEM-constructions have several IVD "manufacturers". Since most IVDs are not covered by Annex A/B they just sell ist without any clue about traceability and vigilance requirements.

Fortunately they are (will be) now inspected by the Competent Authorities all over Europe.