OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope

Hey guys,

This seems like a dumb question but just to be very sure:

The OEM manufacturer of the devices mentioned in the product scope of the OBL's ISO 13485 & EC cert, must have a valid ISO 13485 & EC cert of their own.


If their certs do not cover those devices, then the NB of the OBL will have the right to call for an audit at the OEM's manufacturing site.

Can anyone help to confirm this?

OEM company don't need to have a valid CE certificate or 13485 because OBL NB must have to control all documents anyway.

However, a valid CE and 13485 helps certification process.

Dear Remus, thanks so much for your reply.

If OEM is ISO 9001, and we ask him to make us a product which we sell as a medical device. Can the device be included in our 13485 product scope even though the OEM does not have a 13485 certificate?

Medical device such as: Disposable trays/instrument trays

A quick "Bump" to an old thread - My Thanks in advance to anyone who will help with a current answer.

I'll answer for the European Regulation.

With the MDD 93/42/EC, The OBL is registering a product as a Medical Device. And to prove that this product is correct they use the OEM certificate (CE certificat and QMS certificat). Usually to obtain the CE certificat, the Notified Body is also looking to the QMS and usually it's ISO 13485 that is used as a reference for Medical Device products.

If the OEM does not have a Medical Device certification and is considered as critical manufacturer then yes the notified body has the right to audit them. It's why we recently updated all our agreements with our critical suppliers to include the potentiality of an audit by the Notified Body of the OBL.

But in that case I am not sure we are talking about OEM OBL relationship. The OEM as the original manufacturer need to have the proof that its product is certified so he also needs an audit for that. And getting ISO 13485 additionally to CE mark is not more expensive.

Anyway. with the new MDR 2017/745 the concept of OEM OBL will be completely different. OBL will need the full technical file to register a product so not really easy to ask to an OEM. So this will not exist anymore unless some trick exists.

Hi, may I know, could we include Design & Development in ISO scope for OEM company?

Nurul3110 said:

Hi, may I know, could we include Design & Development in ISO scope for OEM company?

Click to expand...

Certainly if you perform D&D for your customers, yes.