Hi Brandon,
You have touched probably the most controversial Article and probably the most "interpreted in many different ways" Article. The original intent of Article 12 if you read way back in the history of discussion was that a company that wanted to make a "convenience kit" for a physician such as in an ostomy procedure. The "procedure pack" could contain a catheter, a drape, a supply bag, a refuse bag, etc., that then all the components could be together in one "kit".
If you as the manufacturer put all these together, then sterilize the kit, it would require that company becoming a manufacturer and having to CE Mark the kits. Therefore, some companies would argue this could be done easier by just by purchasing all of the individual CE Marked products and put together in a shipping box - saves a lot of time and effort.
What complicates this Article is the scenario you raise where a company purchases in bulk all of the individual CE Marked components and then puts them together into a procedure pack or convenience kit. The controversy or interpretation arises that if you change the packaging of the original CE Marked device, then as a procedure pack company you become the manufacturer. But say you are getting 100 non-sterile products (catheters) that are individual CE Marked and put them individual into each procedure pack, then by default as you are not sterilizing the final kit, this
should be ok. However, there are interpretations ...
To complicate even more Article 12(4) states that this procedure pack should not bear any additional CE Mark, but some Notified Bodies over the years have required the whole kit to be CE Marked, containing a technical file that references all the individual technical files, and even worse the procedure pack generating company to have full access to the technical file for each of the individual CE Marked components.
So while I understand your scenario, my only advice really is that if all Class I, non-sterile have a discussion with your local Competent Authority or if you require a Notified Body for any of the individual CE Mark device, discuss with them your approach. There have been papers published about different points of view on this, suggest doing a little research into this as well to provide your organisation and informed decision. Unfortunately also the new MDR Article 22 does not really make things clearer. Reading the regulations the compatibility of devices needs to be acceptable, information supplied to the user is appropriate, and combining all of these together have the proper V&V. Keep in mind also that if any of the individual products are not CE Marked, then the "pack" must be CE marked by yourself and if anything is changed affecting the General Safety and Performance Requirements (referring to the new MDR), then again this may need to be CE marked by yourself.
I would be interested to hear if others might have some other advice or comments as this is definitely an area of broad interpretation.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 16-Feb-2018 11:20
From: Brandon Brackett
Subject: Article 12 (MDD) Interpretations
Have a question about Article 12 & hoping someone can give me some guidance from experience! My apologies if this question has been posted previously - I ran a search and could not find what I was looking for.
Under Article 12, I am sure you are all familiar with the requirement of each device within the procedure pack having to bear the CE-mark. The problem I'm having is this: many, if not most procedure packers purchase devices for use in their procedure packs in a bulk non-sterile form (many of one type of device all within a single packaging system). They open this package and store the contents in inventory, pulling from these quantities one at a time for use in their procedure packs. This results in a procedure pack containing a variety not-individually-packaged devices. The significance of them not being individually packaged within the kit relates to use in the clinical setting - having to open each item within the procedure pack is not desirable; and really, is pretty much a non-option for clinicians. What I've just described is a typical "Article 11" operation.
With this in mind, I'm back to Article 12's requirement of each device within the procedure back "bearing the CE-mark". If each device within the procedure pack has to bear a CE-mark, I assume this means they all have to be individually packaged - which completely up-ends not only the way procedure packers operate today, but also the way clinicians operate in the clinical setting. The time it would take to open 30 devices for a single procedure would be prohibitive to that as an option.
My question is this: am I interpreting Article 12's requirement correctly? Is it possible for procedure packers to continue manufacturing procedure packs consisting of many not-individually-packaged devices in a kit AND also be Article 12 compliant?
Thank you!
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Brandon M. Brackett, RAC
brandon.brackett@gmail.com
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