Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding

Roland chung

Trusted Information Resource
#1
Hello All,

Since the MEDDEV guide is not legally binding, I can challenge nonconformity issued by NB, like clinical evaluation does not take into account the MEDDEV 2.7/1 revision 4. Is that right?

Best regards,
Roland
 
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Marcelo

Inactive Registered Visitor
#2
You can, but particularly in the case of the Clinical Evaluation MEDDEV, which seems to be pushed by the Competent Authorities, I don't think it's worth it because you will probably only waste time and you will have to comply anyway (that's what's been happening with several of my clients).
 
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Sidney Vianna

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Leader
Admin
#3
Did you ask the auditor, during the debriefing/exit meeting why was s/he issuing a nonconformity against something other than a requirement?

Did you try to dialogue with the auditor? The whole audit experience has to be a two-way street to add value.
 
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Remus

Involved In Discussions
#4
It is easier to refer standards guidences rather than writing everything. Anyway, harmonised standards and Meddev guidances are mandatory for NB's not manufacturers.
 

Ronen E

Problem Solver
Moderator
#5
Did you ask the auditor, during the debriefing/exit meeting why was s/he issuing a nonconformity against something other than a requirement?

Did you try to dialogue with the auditor? The whole audit experience has to be a two-way street to add value.
No disrespect, but with NB medical device audits the purpose is not to add value but rather to verify a certain minimum (though I wonder how many would admit it).
 

Ronen E

Problem Solver
Moderator
#6
harmonised standards and Meddev guidances are mandatory for NB's not manufacturers.
This is an interesting statement that I don't fully understand. As far as I know they are officially voluntary for all. Additionally, I don't understand how, practically, some guidance can be mandatory for a NB without it affecting the manufacturer (ie how can the NB follow it to the letter without requiring the manufacturer to do the same).
 

Ronen E

Problem Solver
Moderator
#7
The problem with the EU clinical evaluation is that the current regulatory requirements are so general and ambiguous that there is no practical way to decisively and directly show either compliance or noncompliance. Practically a detailed guide such as the MEDDEV is necessary, and thus it became de-facto regulation. NBs don't have the ability to judge the clinical evaluation other than by comparison with the MEDDEV. Rev 4 is more demanding than rev 3 and this might seem overbearing, but it's actually a result of yet some ambiguity / uncertainty that were inherent to rev 3.

A similar example would be EN 60601 for medical electrical equipment.
 

Sidney Vianna

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Admin
#8
No disrespect, but with NB medical device audits the purpose is not to add value but rather to verify a certain minimum (though I wonder how many would admit it).
Confirming compliance with regulatory requirements and approving the product to be traded in the EU does not add value to the manufacturer? :confused:
 

Ronen E

Problem Solver
Moderator
#9
Confirming compliance with regulatory requirements and approving the product to be traded in the EU does not add value to the manufacturer? :confused:
I didn't say it doesn't add value, just that adding value is not the purpose. The purpose is to verify a certain minimum. Apparently having such minimum verified represents added value as compared with not having that minimum verified, but since "adding value" (in the general sense) is not the driver but rather the result the process runs out of fuel as soon as the minimum is verified.

In the specific context of clinical evaluation it is apparently simpler and easier for the NB to verify regulatory compliance through compliance with the MEDDEV, than through any other method, so there's no drive on their part to "have a dialogue" or to add value beyond the bare regulatory minimum. At most they would provide clarification, and I would venture a guess that it would go along the lines of MEDDEV being state of the art and so on and so forth.
 

Remus

Involved In Discussions
#10
This is an interesting statement that I don't fully understand. As far as I know they are officially voluntary for all. Additionally, I don't understand how, practically, some guidance can be mandatory for a NB without it affecting the manufacturer (ie how can the NB follow it to the letter without requiring the manufacturer to do the same).
For instance EN ISO 13485, all NB have to prepare its documentation then audit Manufacturers QMS according to EN ISO 13485 otherwise EC won't designate them.
 
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