Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings,

Can anyone share their experiences with a hybrid format of a device kit, where the collection of devices assembled in a kit don't quite fit into either definition of Article 22 or Article 52?  Consider that each of the kit components are all CE marked individually under their own technical files, but for the convenience of clinician use, are placed in the kit without individual packaging.  I'd appreciate any insightful comments.

Thank you!

This message was posted by a user wishing to remain anonymous

Hi Anon,
   Quite an Interesting question given that the link here for Article 22 lists these with respect to sterilization:
where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.

i would assume that this precludes any product that would have
1) DIY/Assembly instructions covering the intended use
2) IFU and Documentation for usage along with Legal declaration of usage
3) Notification about possible expiration of critical components - batteries or chemicals which may cause unsafe operation.

Outside of this any number of McGyver solutions can be made when the exigency exists for products with CE markings

Original Message:
Sent: 12-Oct-2020 17:30
From: Anonymous Member
Subject: MDR procedure packs--Article 22 vs. 52

This message was posted by a user wishing to remain anonymous

Greetings,

Can anyone share their experiences with a hybrid format of a device kit, where the collection of devices assembled in a kit don't quite fit into either definition of Article 22 or Article 52?  Consider that each of the kit components are all CE marked individually under their own technical files, but for the convenience of clinician use, are placed in the kit without individual packaging.  I'd appreciate any insightful comments.

Thank you!

It would be useful if you could explain more about why this product doesn't quite fit into either definition of Article 22 or Article 52. I have not been able to imagine a product that isn't in either Art. 22 or Art. 52.

From your description, it appears that Article 22(1)(a) applies. I don't think taking the devices out of the individual packaging makes a difference.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 12-Oct-2020 17:30
From: Anonymous Member
Subject: MDR procedure packs--Article 22 vs. 52

This message was posted by a user wishing to remain anonymous

Greetings,

Can anyone share their experiences with a hybrid format of a device kit, where the collection of devices assembled in a kit don't quite fit into either definition of Article 22 or Article 52?  Consider that each of the kit components are all CE marked individually under their own technical files, but for the convenience of clinician use, are placed in the kit without individual packaging.  I'd appreciate any insightful comments.

Thank you!