Applicability of new non-harmonized standards (MDD/MDR)

RA_QA_Expert

Starting to get Involved
#1
Hi all,

I would like to ask you for your advice.

We plan to buy new infant beds (cribs) for hospital. Class I Medical devices, nonsterile, without measuring function.

I found technical standard EN 50637 Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children issued in 2017, which is applicable for this type of beds. On the other hand, this standard is not harmonized with MDD/MDR.

We asked some manufacturers how they meet this standard. Some answers are, that they do not have to meet it, because non-harmonized standards mean volunatry standards. We also recieved some bisk-benefit studies, based on PMS, clinical evaluation and risk assessment, which explain why this standard doesn´t have to be applied (from MDD/MDR perspective).

Is that acceptable? Are CE marking and EC Declaration of Conformity valid? This standard should be state-of-the-art standard.
Thank you for any hints.
 
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shimonv

Trusted Information Resource
#2
You are not in a position to evaluate the conformity of the bed manufacture with all the applicable requirements of MDD or MDR; the notified body does that.
If you are concerned about this, I would recommend that you purchase units from one that manufacturers who were assessed by one of the more reputable notified bodies, preferably one of those who are approved for MDR.
 

RA_QA_Expert

Starting to get Involved
#3
You are not in a position to evaluate the conformity of the bed manufacture with all the applicable requirements of MDD or MDR; the notified body does that.
If you are concerned about this, I would recommend that you purchase units from one that manufacturers who were assessed by one of the more reputable notified bodies, preferably one of those who are approved for MDR.
Thank you, I understand, it would be good solution.
Nevertheless, as I mentioned above, this is Class I Medical devices, nonsterile, without measuring function, that means a manufacturers use "self-certification" process without NB...

But in general, it is possible/legal, that the manufacuter can decide to not use non-harmonized standard, even it is state-of-the-art standard?
I understand, if there is any similar or still valid previous version of any standard (e.g. EN ISO 14791:2019 vs. 2012 version), that I can wait until the previous version is still valid, but what if there is total new standard without any previous version (our case)?

thanks a lot
 

François

Involved In Discussions
#4
The use of standards (harmonized or not) is never mandatory. The use of harmonized standards is a way to prove more easily that you're in conformity with MDD or MDR when available. But a manufacturer is free to comply with regulation by using other methods.
 

shimonv

Trusted Information Resource
#5
But in general, it is possible/legal, that the manufacuter can decide to not use non-harmonized standard, even it is state-of-the-art standard?

I understand, if there is any similar or still valid previous version of any standard (e.g. EN ISO 14791:2019 vs. 2012 version), that I can wait until the previous version is still valid, but what if there is total new standard without any previous version (our case)?
Yes, it is possible. Manufactures are not expected to comply with any related standard, and there are many international and local standards out there. However, manufactures are expected to follow the generally acknowledged state of the art or provide justification for not doing so. This should be a part of their QMS processes for updating the list of applicable standards.

Since it's a class I device and you want to be assured of the quality of the infant beds, what you can do is to read the standard and challenge the manufactures about applying or not applying it in their organisations. Obviously, quality assurance is composed of many layers but this interaction with the manufactures should give a good indication on how serious they are about their work.
 

dgrainger

Trusted Information Resource
#6
If you want to purchase beds that meet the standard then make it a requirement in your specification.
What to you mean by a "state-of-the-art standard"?
 

Philip B

Involved In Discussions
#7
I suggest you need to determine state of the art for your industry/products. MEDDEV 2.7/1 rev 4 has lots of guidance on this. You should document your understanding of the current state of the art in your clinical evaluation report. State of the art might (or might not) include compliance with standards (harmonised or otherwise). The standard you mention is fairly recent so we will probably have some contribution to state of the art for your industry. If your Notified Body deems it to represent state of the art they may well expect you to be meeting it, or have a documented justification if not. Hope this helps, the MEDDEV is a bit of a slog but there is some good stuff in there.
 

Mark Meer

Trusted Information Resource
#8
Are CE marking and EC Declaration of Conformity valid?
Yes, CE marking and EC Declarations of Conformity can still be valid even if harmonised standards are not applied. The DoC is a declaration by the manufacturer that the device meets regulations and, as mentioned in this thread, application of standards (harmonised or not) are an optional (though reliable, particularly if harmonised) way to demonstrate conformity.

You can certainly request evidence of how the manufacturer is demonstrating conformity to general safety and performance requirements, if not via applied standards, and evaluate whether this is acceptable to you. I agree with @dgrainger that if the particular criteria of the standard are important to you, then make them requirements of purchase, or request evidence for meeting specific considerations of the standard.
 

RA_QA_Expert

Starting to get Involved
#9
So the summary is following (based on information above and EC Blue Guide):
  • Compliance with technical standards is voluntary
  • The MDD and MDR lay down essential requirements on safety and performance of the devices they cover, but do not prescribe any specific mandatory technical solutions for the manufacturing and design of the devices - other technical specifications however do not benefit from the presumption of conformity
  • The precise technical solution may be provided by a standard or by other technical specifications or be developed in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature at the discretion of the manufacture, that means, the conformity of a product may be demonstrated not only by harmonised standards but also by other technical specifications
Therefore, the manufacturer can choose which technical solution to use to meet these essential requirements. However, if the manufacturer chooses not to follow the applicable technical standards, he has the obligation to demonstrate that his products are in conformity with essential requirements by the use of other means of his own choice that provide for the level of safety or protection of other interests required by the applicable legislation.

Justification for not using relevant technical standards (harmonized or not) must be part of Technical documentation. This justification must be made based on risk analysis and clinical evaluation and must provide sufficient level of objective evidences that relevant ER/GSPR are met.

If NB involvement is part of conformity assessment procedure, the justification must be approved by NB.
If the medical device is pure class I, it is up to manufacturer and only National Competent Authority can control this (and only in case of serious incident or as part of inspection).

Thanks for interesting discussion.
 
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