MDR 2017/744 Article 22

[Chitchat]

I'm trying to confirm my understanding of the requirements.

We are assembling a procedure kit that consists of approximately 20 components, a mixture of off-the-shelve CE-Marked and Non-CE-Marked components and bespoke components all of which will undergo sterilization. Am I correct in saying that it is Article 22(4) that applies in this instance and the system or procedure pack needs to be treated as a device in its own right and submitted to a relevant conformity assessment procedure pursuant to Article 52?

Am I responsible for the post-market surveillance of all components in the kit?

In terms of classification, I presume the classification of the procedure kit is in line with the highest risk component, which is an implanted catheter, IIb implantable? If the procedure pack contains a drug (a third party anesthetic) could this change the classification of the kit?

From a US perspective, we a pursuing the 510k SE pathway. Do I need to include all components in the submission, or can I claim an exemption to 801.30(a)(11) under the Convenience Kits Interim Regulatory Guidance of 1997, if my procedure kit falls within one of the convenience kits listed in this guidance and only make a submission for the bespoke components?

 

[Martin Med]

*Note that a kit is an IVDR concept that does not exist in the MDR. I assume you mean Procedure Pack here. The difference may be relevant for you, as a Prcoedure Pack does not exist under the IVDR.

I would agree that following Article 22(4) means your product should be treated as a device in its own right if sterilising falls outside the intended use of the component manufacturer.

Yes, if then placed on the market as a device you will be responsible for PMS of all components of the device.

Classification of products affected by Article 22(4) is discussed in MDCG 2021- 24 (3.1.7 Systems and procedure packs). Note that if you manage to fulfill the requirements for a Procedure Pack, the classification is not necessary as it is not a medical device.

 

[AMW02053NOV]

Hi Martin,
In terms of PROCEDURE PACKS and SYSTEMS, would a PP that combines all CE-Marked, compatible products being used to their intended purpose(s) (some CE-IVD and some CE-marked under MDR) be considered a PP that can be register under Art. 22, with an UDI but without CE Mark? If the primary intended purpose is the IVD component, with the medical device as an accessory, is it still considered a Procedure Pack under the MDR Art.22?

In other words, even though IVDR does not have a specific PP&S Article, IVDs can be included in PP&S [as per 22.1(b)]

Thanks and regards
-AMW

 

[Martin Med]

Hi Martin,
In terms of PROCEDURE PACKS and SYSTEMS, would a PP that combines all CE-Marked, compatible products being used to their intended purpose(s) (some CE-IVD and some CE-marked under MDR) be considered a PP that can be register under Art. 22, with an UDI but without CE Mark? If the primary intended purpose is the IVD component, with the medical device as an accessory, is it still considered a Procedure Pack under the MDR Art.22?

In other words, even though IVDR does not have a specific PP&S Article, IVDs can be included in PP&S [as per 22.1(b)]

Thanks and regards
-AMW

The way I see it this should be ok. Your pack meets the requirements for having atleast one Medical Device (CE marked under the MDR), and having an intended use with a specific medical purpose. Article 2 points 1 and 2 of the IVDR mean devices CE-marked under the IVDR by definition have a specific medical purpose.