EU MDR - Applicability Article 22 Systems and Procedure Packs

#1
Hi,

I am reviewing the applicability of systems and procedure packs (Article 22) and have a few questions that I would like to get your thoughts on:

Systems - If multiple devices are used together for a therapy, but are not packaged together, are not labelled together, are not produced together, are not shipped together (or from the same location) and each is CE marked….. given they are already CE marked devices that may (or may not) be used together do we need to produce a statements per Art. 22?

Drug device co-packaged products - If a product is CE marked and co-packaged with a medicinal product and then placed on the market with the purpose of being used for a specific medical purpose (where the device is non-integral and the mode of action is ancillary to that of the drug), would it, per Article 22, be considered a procedure pack?

Thanks
 
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#2
With regard to the first scenario - this would not qualify as a system or procedure pack. Most devices will require other devices in other to function correctly within a clinical procedure, however there are relatively few procedure packs in the EU regulatory system. They are the exception, not the norm.
You say that the devices are not combined together physically as one product i.e. packaged and supplied to the customer together. To classify as a procedure pack, you should be supplying the devices together to one customer and assigning a medical use to the pack e.g. a hip repair pack, or a knee replacement set, i.e. generally procedure packs are designed as a supply chain solution to reduce packaging and streamline inventory control for hospitals. It is not the intention that companies should retrospectively assign a procedure pack status to their devices if they are supplying them all separately for use in the same clinical procedure or therapy. But if it was deemed to make sense to package all these devices into one 'set' and assign a new product code and medical purpose to this 'set', then it would qualify as a procedure pack.

With regard to the second scenario - according to article 22, a procedure pack can consist of CE marked device combined with other products as long as the other products are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
Therefore it sounds like scenario two is a procedure pack as the CE marked device and the medicinal product are being packaged together and placed on the market for a specific medical purpose. This certainly fulfills the Article 22 definition of a procedure pack.
 
#3
Thanks for the reply.

With regards to the first scenario I agree that it would not be considered a procedure pack, however, can it be qualified as a system. Article 2(11) defines a system as a combination of products, either packaged together or not, which is intended to be interconnected or combined to achieve a specific medical purpose. Since the devices are are used for a specific therapy and are to be combined would this be considered a system? or since a natural or legal person isn't combining the system and placing on the market in accordance to art. 22(1) they are exuded from scope and the manufacturer of the device and would need to ensure that compatibility of their device per GSPR 14.1 (if intended to be used with another device without combining the other devices and placing on the market as a system)? I hope my question is clear!

Second scenario I agree with you statement.
 
#4
I see the distinction you are making between the system and procedure pack, but it doesn't change the scenario.
In the MDR, Annex I, it is envisaged that devices will need to connect with other devices and as you mention, these requirements are covered in GSPR 14.1.
The Article 22 route is a regulatory route to enable more flexible supply chain solutions. In reality, it allows natural or legal persons who do not own the CE mark of the individual devices to supply them together as one sales unit and do a relatively simple assessment as to the mutual compatibility of the combined devices, normally through a review of the intended use of the individual devices.
This does not negate the need for the Legal Manufacturers to have done their due diligence and validated the inter-connect ability of their device.
In short, unless you want to explicitly market your devices as a System, with one product code assigned to the System, then there is no need to apply the Article 22 System requirements to two individual CE marked devices which may or may not be used together for a specific medical purpose.
 
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