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ISO 13485 Class I Medical Device Design Exclusion

B

Bomiss

#1
Hello All,

Thanks to everyone for participating on this form. The participation allows the novice (like me) to gain a better understanding through the discussions. I have been reading the content for a few weeks and I am impressed, not only about the knowledge content, but also the considerate approach to finding resolution to the questions proposed on the forum.

Now for the issue I have at hand, I would appreciate a better understanding of the Design requirements for ISO 13485. I have recently started a new business and I need validation on my perception of Design Exclusions in regard to ISO 13485. The FDA’s GMP CFR 820 standard states that Class I and some Class II medical devices are excluded from Design Controls. The product I manufacture is a class I, non-invasive, non-sterile, plastic/rubber medical device used in Dentistry. The product category is not listed in the chart of Class I Medical devices that have to have Design Controls.

It is my interpretation, that even if I designed the product, I would not need to use design Controls in my business. At this time, we are a very small company and all Design, Engineering, Quality, and other business functions are managed by one person.

If I am misled please help me understand.
Thanks
 
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RA Guy

Involved In Discussions
#2
I believe your assertions are basically correct, but will put them in my own words for clarity.

For FDA purposes, it is explicity prescribed which devices require design controls/gmp and which devices do not require. Having said that, even for simple, low risk devices there are valid reasons, beyond simple compliance, to have design documentation and a project management approach as implied by design controls.

The second paragraph of 13485 Section 1.2 defines the criteria for exclusions under sec. 7.3. Essentially it is allowable only if permitted by the applicable regulator in the country whee you will maket the device.

For instance in Canada regarding device licencing requirements:
Class I - ISO13485 not required
Class II - ISO13485 CMDCAS required for manufacturing
Class III & IV ISO13485 CMDCAS required for design and manufacturing

That means for a class II device in Canada, design is an allowable exclusion from the application of 13485 CMDCAS.
 
B

Bomiss

#3
Thanks for the quick reply. I appreaciate you shaing your knowledge and understanding of the requirement.
 
M

MIREGMGR

#4
Generally speaking, Europe requires that all medical devices conform to the Medical Device Directive, and in particular to the Essential Requirements, Annex I. The Essential Requirements are normally interpreted to require design controls, and do not exclude any device classes.
 
B

Bomiss

#5
MIREGMGR,

Thanks for the reply. For clarification, I should not have an issue with ISO 13485, however, when I plan on selling product in the EU, I will need to satisfy the requirements of Design Control. Is that your understanding?

Thanks
 
M

MIREGMGR

#6
The latter part is correct.

Regarding implementation of ISO 13485, standards are applied in a context, as RAGuy illustrates above. They aren't meaningful without knowing that context, since it determines their applicability and interpretation. Who will be determining your conformance to ISO 13485, and with regard to what jurisdiction's requirements?
 

Ronen E

Problem Solver
Staff member
Moderator
#7
The Essential Requirements are normally interpreted to require design controls, and do not exclude any device classes.
This is quite a broad statement that doesn't match my knowledge and/or experience; I'd be glad if you could kindly provide a pointer to a regulation, guidance or otherwise, that support this approach. I can imagine some of the stricter NBs applying such an approach, but definitely not all of them for all device classes. In the EC, plain class I (non-S non-M) devices do not require a qualified QMS, let alone design controls; a NB intervention would also not be required, so I wonder who would then require the implementation of design controls.
 
M

MIREGMGR

#8
That's our reading of the MDD, and my understanding of how our competitors see it as well, from my contacts with them. Some applicability of the MDD is legally self-controlled, of course, rather than being imposed via NB enforcement. My understanding however is that our NB and our Authorized Representative have the same interpretation of the MDD, as communicated during their various oversight of our tech files, processes and listings for the many Class I and I-s devices we make.

Perhaps as you suggest our NB and Authorized Representative are more rigorous than some others.

As a possibly relevant data point, we know that US FDA and the EU authorities among others have been discussing what evolutions of the various systems may occur as those systems are eventually moved toward harmonization. My understanding is that US FDA's thinking is that their current exclusion of design control for (mostly) Class I devices will be one of the things they'll sacrifice in that harmonization process, moving instead to (as I understand it) an MDD-like expectation of design control for all devices.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
That's our reading of the MDD, and my understanding of how our competitors see it as well, from my contacts with them. Some applicability of the MDD is legally self-controlled, of course, rather than being imposed via NB enforcement. My understanding however is that our NB and our Authorized Representative have the same interpretation of the MDD, as communicated during their various oversight of our tech files, processes and listings for the many Class I and I-s devices we make.

Perhaps as you suggest our NB and Authorized Representative are more rigorous than some others.

As a possibly relevant data point, we know that US FDA and the EU authorities among others have been discussing what evolutions of the various systems may occur as those systems are eventually moved toward harmonization. My understanding is that US FDA's thinking is that their current exclusion of design control for (mostly) Class I devices will be one of the things they'll sacrifice in that harmonization process, moving instead to (as I understand it) an MDD-like expectation of design control for all devices.
Once again, so we don't confuse newcomers, there's no explicit MDD expectation of design controls for all devices. To me, yours seems to be an interpretation that exists in a closed set of NB(s?) and companies. The authorised representative may provide advice, but is certainly not in a legal position to require anything of that sort (unless such power is granted to them in a specific contract). I don't know what the FDA intends to do with regards to design controls in the future, my comment related to the state of things in the EC, as I know them today.

Perhaps your NB promotes implementation of design controls for your class I devices because:
1. It is a good practice and makes a lot of sense anyway.
2. it is an easy/simple way (not the only one) of complying with the ERs.
3. It makes a lot of sense to employ a single set of principles / system for all devices you make, regardless of class, and since some of your devices are higher class than I(?), you have to have design controls established in your organisation anyway.

Either way, I see it more as a strong recommendation than as a mandatory requirement.
 
M

MIREGMGR

#10
Once again, so we don't confuse newcomers, there's no explicit MDD expectation of design controls for all devices.
The Essential Requirements state in a number of locations, "The devices must be designed (...)", followed by a specification for particular required performance or other characteristics. It is at least a common interpretation of this set of stated requirements that the design process, just as the manufacturing and packing processes in certain cases, must be controlled so as to accomplish the stated requirement...and of course, as a general requirement in line with the universal dictum that "if it's not documented it didn't happen", that design process must be documented.

I gather that you're arguing for an alternate interpretation of the "must be designed, manufactured and packed" requirements, in which there isn't any requirement for control of processes as long as the device outcome is acceptable. I don't think the rather extensive historical record of drafter intent supports an interpretation that doesn't include control of processes, though. Certainly that's the understanding that's expected by the regulatory parties with which my employer interacts.
 
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