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EU Class 1s CE Mark Regulatory Pathway

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#2
Hi Emulchandani,

Your answer is found in the MDD, Annex VII, paragraph 5:

With products placed on the market in sterile condition and Class I devices with a measuring function, the manufacturer must observe not only the
provisions laid down in this Annex but also one of the procedures referred to in Annex II, IV, V or VI. Application of the above mentioned Annexes and the intervention by the notified body is limited to:
— in the case of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions...


This means you'll need a Notified Body to audit your quality system, most likely against MDD Annex II or V, and review the sterilization related aspect of your technical file. In the end you'll receive a certificate which you will refer to in your Declaration of Conformity.
 
#4
Thank you. Manufacturing will be in-house. So essentially it would be similar to a class II or III device in terms of quality system and technical documentation review except the NB will only focus is on sterilization?
 
#5
This is what the AR has told me which generated the confusion in terms of NB auditing the QMS:

In fact, no Notified Body is necessary for a Class 1 Device. However, there are some testings required for the technical file (eg mechanical), where we include the Notified Body to perform the tests according to the regulation.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thank you. Manufacturing will be in-house. So essentially it would be similar to a class II or III device in terms of quality system and technical documentation review except the NB will only focus is on sterilization?
You mention "a class II or III device" which might indicate you are referring to the US system (in the EU it would be either IIa or IIb, no "class II" as such); in which case the relevant reference would be part 820, so I would say not necessarily similar. Annex V excludes Design & Development, and in the US system a class II or III device would be subject to Design Controls (820.30) so that's a significant difference. Other than that you are partly correct - all class I devices are subject to Annex I and Annex VII so you'll have to be in compliance regardless of NB intervention, plus your Annex V (as a minimum) QMS will have to fully address all sterility aspects. NB intervention should not only "focus" on sterility aspects but actually be limited to them (watch for regulatory creep).
 
#8
So if a Class Is (also class 1 in US, no design controls), would the most efficient pathway be Annex V rather than Annex II because the lack of design and development requirements?
 
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