Moving to a different Notified Body

[Camcar2]

Has anyone any experience in moving to a different notified body? Is it a painful & expensive process and not worth the hassle? Finding our current notified body painfully slow (6 months to even get a date for a review of a change to an IFU) affecting our manufacturing and distribution of product and therefore impacting on the business. Any advice greatly welcomed.

 

[SteveK]

Question;

Why would you require or want a NB to review an IFU? It is hardly a 'significant' or 'substantial' change to a QMS.

Steve

 

[Camcar2]

its a contraindication change in the IFU which is a significant change (clinical). Our ISO13485 certificate includes design and manufacture of a class IIb medical device. NB needs to be informed of label / IFU / design changes etc.

 

[pkost]

I hate to say it, but 6months or thereabouts seems to be the norm at the moment (at least for UK NBs).

I would be wary of the promises of the commercial sales reps for NB's, verify their claims with the technical leads in notified body's and make sure your contract is sufficiently robust when it comes to the service levels

 

[J0anne]

Has anyone any experience in moving to a different notified body? Is it a painful & expensive process and not worth the hassle? Finding our current notified body painfully slow (6 months to even get a date for a review of a change to an IFU) affecting our manufacturing and distribution of product and therefore impacting on the business. Any advice greatly welcomed.

It's not a painful or expensive process, in fact you can possibly reduce costs, but be sure to plan ahead and make sure you don't increase costs instead.

Your re-certification audit is a good time to change. Shop around and ask questions on certification and audit timings and pricing. Don't forget to ask the NB for time limits for completion of assessments and verification of operations (Annex II-VI). Also also ask for timescales for reviews of significant changes.

You might want to consider NBs that offer more tailored services such as participation in the ROC - TCP (Taiwan Technical Co-operation Program) etc. You can save substantial time and money there as well.

 

[Reg Morrison]

Depending on the products and it's CE-Marking, it can get tricky, as there can not be ANY confusion about the products that got CE-Marked as to who was the Notified Body involved.

One needs to be able to ascertain without a question, which NB was authorizing the manufacturer to apply the CE-mark onto the product.

So, it is critical to have a reliable traceability of the production and when the former NB became out of the picture and the new one started.