EC Certification Process and Time Frame for Own Brand Labeling Medical Devices

A

Aliasanonymous

#1
Hi

My company is looking to do Own Brand Labelling (OBL) for medical devices. The partnership would be with an ISO 13485 certified company and the devices we bring in would be CE certified and labelled at the OEM.
Would anybody happen to know what the process of EC certification be like on our side?
And also, are there any Notified Body you would recommend for quick approval and certification? I've had some NB telling me it will take a year, which is a really long time.

Thank you in advance!

Regards.
 
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O

orlysh

#3
It depends but from my experience it takes 3-6 months, if your OEM has a CE already. 1 year sounds like a lot
 

pkost

Trusted Information Resource
#4
For OBL, 12 months is excessive.

Once we have a supplier and product selected, we can turn around OBL products in about 2months with our notified body (these are class IIa products).

From the notified bodies perspective there is not very much to review, therefore it shouldn't take much time
 
#5
Hi

My company is looking to do Own Brand Labelling (OBL) for medical devices. The partnership would be with an ISO 13485 certified company and the devices we bring in would be CE certified and labelled at the OEM.
Would anybody happen to know what the process of EC certification be like on our side?
And also, are there any Notified Body you would recommend for quick approval and certification? I've had some NB telling me it will take a year, which is a really long time.

Thank you in advance!

Regards.
The turnaround depends on the content of the submission and the NB's availability.

As long as your submission contains all the relevant information and you have a pre-booked timeslot for the NB to review it, then approval should be swift and you should have your certification in less than three weeks.
 
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