OBL under new MDR

S

Shaka256

#1
Hi all,
Our company produces and distributes medical devices under our name and we are also doing product development and production for another company (company B).
If we choose to go according to Annex IX for conformity assessment then from what I understand it is performed for a family of devices. Is there a way to have the conformity assessment performed for our devices and separately for company B? We are the manufacturer of all devices and our devices are the same "family" as company B's devices.
Hope I'm making sense.
Thank you!
 
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Marcelo

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#2
Hi all,
Our company produces and distributes medical devices under our name and we are also doing product development and production for another company (company B).
If we choose to go according to Annex IX for conformity assessment then from what I understand it is performed for a family of devices. Is there a way to have the conformity assessment performed for our devices and separately for company B? We are the manufacturer of all devices and our devices are the same "family" as company B's devices.
Hope I'm making sense.
Thank you!
In principle you require and evaluation of the system in Annex IX. The technical documentation evaluation depends on the risk class (all devices for Class III, generic device group for Class IIb, at least one representative device for each category of devices for Class IIa). However, unless the system explicitly exclude some devices, they will be part of the evaluation (they might not be explicitly evaluated on the sampling basis described above, but they will be part of the evaluation nonetheless).
 

suildur

Involved In Discussions
#3
Hi all,
Our company produces and distributes medical devices under our name and we are also doing product development and production for another company (company B).
If we choose to go according to Annex IX for conformity assessment then from what I understand it is performed for a family of devices. Is there a way to have the conformity assessment performed for our devices and separately for company B? We are the manufacturer of all devices and our devices are the same "family" as company B's devices.
Hope I'm making sense.
Thank you!
It is not about product family, it is about what you have defined in your QMS and what you really do in the production.

First of all, you must define your supplier position in your QM and production procedure(s), so that you can define the different companies' products other than your company's own products. Also, while you operate ISO 13485, you still have responsibilities related to QMS for company B's production. Also, during the audit (and so on), you must prove that Company B's products are not yours by using the QMS tools (different production records, same production records with proper identification of the client's product or any other method). You must also prove the tracebility and the monitoring of the two separate production. Then, Company B's production (which is done by your company) will not affect your CE marking process on the technical dossier side, but it will affect on the QMS side.

Also, if the company B must mark their products according to MDD, they must establish their own QMS particularly controling and managing your producting as if it is their production. That QMS must interact with your QMS, too.
 
#4
Sorry, but I'm still confused, If my company is now an OBL under MDD, in order to meet the MDR it has to submit itself the dossiers to NB, or can still use the certification of the product done by the OEM company?
 
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