MDR article 54(2) "modifying"

#1
In MDR, (b) of the article 54(2) is below.

2. The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
(b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or

and MDCG 2019-3 said the word “modification” shall be meant as limited only to those modifications needed in order to comply with the new legal requirements introduced by the MDR.

If the intended use is same as the marketed device, but only the dimensions are changed, can it be said that it is a modified device according to the article 54(2b) and MDCG 2019-3?

I wonder if CECP can be exempt if I add a model with only the dimensions modified when applying the MDR.

Thank you.
 
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#2
Discuss this with your NB:

2. The procedure referred to in paragraph 1 shall not be required for the devices referred to therein:
(b) where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or

I think there's still no clear path outlined. The only change satisfying MDCG 2019-3 would, in my opinion, be labelling. If you change the dimensions by adding an intermediate length in your hip stems, your chances are good that the NB accepts this. If you add a shorter or longer size, especially one not covered by similar devices, that's something else.

Be aware that the NB has to justify the decision in the CEAR, and that the CEAR has to be submitted to the commision in any case (Article 54(3)). And, the same question will arise when you introduce the change after initial certification. Will be more costly, but you will have your original device on the market already.

So, discuss with your NB.
 
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