Custom made class 1 Medical devices

#1
Hi fellow forum users,

Finding it difficult to determine our exact obligations under the MDR as manufacturers of custom-made class I (rule1)medical devices (orthotic insoles & AFO's). Any advice would be appreciated! Am aware that Art 52 and Annex XIII set out the requirements for CMD manufacturers. Have carried out a lot of research, some of which is conflicting and confusing... Have lots of questions but do not want to bombard!

Having reviewed both the MDCG2021-3 (Q&A on CMD’s) and the MDCG2019-15 (Class I devices); is it the case that one of these can one of these 'trump' over the other? We satisfy the definition for custom-made as defined per Article 2 (3).

In terms of a QMS, all device manufacturers must have a QMS per Article 10 and per section 9 this QMS can be proportionate to the risk class and type of device. Taking into consideration that many other companies in the industry are using 9001, assume we can follow the similar pattern, and include justification in our documentation for not using the recognized harmonized standard of 13485. Anyone else have experience of this?

Appreciate feedback.
Regards,
Mary.
 
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yodon

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#2
I presume you're aware that 9001 and 13485 diverged a bit back when the 'high level standard' (I think that's the name) came out? 9001 followed it but 13485 did not. So that alone is going to make it a harder row to hoe. As you indicated 13485 is harmonized so complying with it gives you a presumption of conformity for complying with the applicable regulations. If you don't have your QMS certified by an accredited certification body then you are also getting into a potentially difficult situation.

With a Class I device (self-declared CE?) I'm not sure how much evaluation you might get but I would not want to risk it. Getting from 9001 to 13485 compliance isn't that big a leap. Of course, getting it certified is costly and takes time.
 
#4
I presume you're aware that 9001 and 13485 diverged a bit back when the 'high level standard' (I think that's the name) came out? 9001 followed it but 13485 did not. So that alone is going to make it a harder row to hoe. As you indicated 13485 is harmonized so complying with it gives you a presumption of conformity for complying with the applicable regulations. If you don't have your QMS certified by an accredited certification body then you are also getting into a potentially difficult situation.

With a Class I device (self-declared CE?) I'm not sure how much evaluation you might get but I would not want to risk it. Getting from 9001 to 13485 compliance isn't that big a leap. Of course, getting it certified is costly and takes time.
Thanks Yodon,

Starting from scratch here so lots to consider.
 
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