ISO 13485 justification for design and development exclusion for medical packaging

#1
I am a former automotive quality engineer in a new position in the medical packaging field and I am trying to understand if 7.3 - Design and development applies to our QMS and subject to audit or if it can be excluded because packaging is not a controlled schedule medical product? Any leads to reading materials or standards to help me understand this is most appreciated.
 
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Billy Milly

Involved In Discussions
#2
Hi, by definition, medical device consists of the device itself, packaging, labelling and IFU. So it is a part of the medical device. It gets even trickier if the device is sterile, because packaging provides a sterile barrier.
Are you a packaging manufactueter/supplier or you manufacutre finished devices?
 
#3
Thanks for the info Billy. We are a manufacturer of roll stock films for our customers to package in sterile flexible medical packaging at their facility. We also manufacture bags and pouches for customers to package their medical devices. The 13485 requirements are specific in how they are applied. I am having trouble finding reference material and source documents that specify details for exemptions under specific conditions. Thanks.
 

Philip B

Quite Involved in Discussions
#4
We re-pack and sterilise other company's devices and have always excluded D&D from our QMS. The clause is intended, I believe, for manufacturers who make actual medical devices. If your product is not a medical device in its own right then you should be ok to exclude D&D but check with your notified body if unsure.
 
#5
Thanks, Philip. I believe this is the premise of our present QMS as well but we are unable to get clear guidance that this is our correct path. Also, there seems to be some worry that we should be including 7.3 more formally. Aside from getting direction directly from our auditing firm, what I’m hoping to find is where else I can get definitive guidance to use for reference for excluding D&D from our QMS or that it should be included? Thanks.
 

planB

Super Moderator
#6
@rob3027 , is it correct to state that you only offer off-the-shelf flexible sterile barrier systems that are not specifically designed and developed for a customer, but are from your range of pre-fabricated bags and pouches? If yes, this might be the rationale to exclude section 7.3.
 
#7
Actually we offer both off the shelf and customer specific materials and packaging. Does this mean we must include 7.3? Is this just tribal knowledge or a specified directive somewhere?
 
#8
First, thank you all for your patience and understanding in that I am learning the differences between ISO13485 and the other quality systems I have been involved with since QS9000 in the mid 90's. Second, I do appreciate your insight and opinion on this matter very much and I only hope to come through this on the other side as nearly competent as the people who's posts I have really enjoyed reading here.

So, here is my fully involved question: Is medical packaging a medical device that is required to follow Clause 7 of the standard? I say no based on these findings:

ISO 13485:2016
Introduction 0.1
General There is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devices. These groups are defined in Clause 3.

1 Scope If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

3.11 medical device instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: • — diagnosis, prevention, monitoring, treatment or alleviation of disease; • — diagnosis, monitoring, treatment, alleviation of or compensation for an injury; • — investigation, replacement, modification, or support of the anatomy or of a physiological process; • — supporting or sustaining life; • — control of conception; • — disinfection of medical devices; • — providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others include: — disinfection substances; — aids for persons with disabilities; — devices incorporating animal and/or human tissues; — devices for in vitro fertilization or assisted reproduction technologies. [SOURCE:GHTF/SG1/N071:2012, 5.1]

4.2.2 Quality manual
The organization shall document a quality manual that includes:
• a) the scope of the quality management system, including details of and justification for any exclusion or non-application;
• b) the documented procedures for the quality management system, or reference to them;
• c) a description of the interaction between the processes of the quality management system. The quality manual shall outline the structure of the documentation used in the quality management system

Please let me know if you concur or not, and if not, why? Thanks so much for your kind attention.
 

Schkund

Involved In Discussions
#10
With regards to the question of customer-specific products, I would say that if your customer comes to you and says, "We want you to make a package with material X that we, the customer, have selected with this criteria that we have put together" you can easily use that to justify exclusion of 7.3. Clearly, in that case, the customer is the one who designed the packaging and your company is simply the contract manufacturer that they selected to produce it. You can simply state that the customer is the design owner in your Quality Manual as justification for excluding 7.3.

On the other hand, my understanding is if the customer comes to you with a product that they would like to package and says something like "we want to package this so that it can be gamma sterilized, get thrown off a 10-story building and maintain a sterile barrier, and fit in a 4"x4"x2" first aid kit... we know nothing about what sort of pouch will meet these requirements so we want your company to pick the materials, conduct testing, and do all of the activities of designing a package for us" you may be veering into 7.3 territory, depending on who takes control of approving the final design and ensuring that the package meets all necessary requirements. With customer-specific designs, it may depend the conditions of the agreement between the two companies.

Of course, none of this means a thing if you're not dealing with a product that falls under ISO 13485:2016 conditions of being a medical device. I fully agree that your pouches do not constitute a finished medical device. However, I am less confident of its exclusion from the portions that I've underlined below:

3.11 medical device - instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: • — diagnosis, prevention, monitoring, treatment or alleviation of disease.

If your pouch is acting as a sterile barrier, it is a related article used to prevent disease by protecting the device inside from microbial contamination that could cause disease. I am in no way, shape, or form an expert in interpreting ISO definitions, but I would definitely pause before eliminating pouches from this scope.
 
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