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!

Hello,

There was a similar thread asked about this recently.  I did this a couple times with "bulk" already CE Marked products put into an overall kit out of convenience and special configuration needs of the physicians.  In one case, the Notified Body would not accept "loose" items and we had to CE Mark the entire kit, maintain the technical documentation, and there was a lot of discussions around ensuring already finished medical devices were identified as suppliers in our QMS.  Keep in mind this was pre-Own Brand Labelling issues, so we did not have to worry about having access to the technical documentation for each of the devices though I imagine now under the EU MDR this will be expected (or required).  Because they would not allow us to have loose items in the kit, we had to individually label each "component of the kit" or each of the finished medical device with minimum information like the CE Mark, part number, expiration date, etc.  Then in the IFU we had to list all the devices in the kit along with the original manufacturer.  Another instance where we did this, the Notified Body was ok as long as each medical device was listed on the outside packaging kit what was in the kit.  We still only CE Marked the overall kit (example I provided earlier), but internal to the company we had to have the full traceability of each of the component/finished devices in the kit including CE Certificate, original Manufacturer, contract/agreements, and any other technical information like shelf life.  Long story ... which would take many rows or text ... shortly it was quite complicated, but the important thing is discuss this with your Notified Body and gain their acceptance to the process.  It seems each treats this differently so you want to make sure they are in agreement with the identification, traceability, CE Marking, and access to technical documentation for all the devices in the kit.  Under the current EU MDR, I would imagine if you are taking loose/bulk products and putting them together, most Notified Bodies would view you as the legal Manufacturer with all regulatory responsibility for the kit since some would view products not in their individual packaging would be a modification (especially if you are sterilising the kit after putting everything together).

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-Oct-2020 10:10
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!

I agree with Richard, but just to expand on Richard's final comment regarding kit sterilization, where some of the individual kit components have already been sterilized once, double sterilization must be covered in the kit risk analysis and, potentially, the kit manufacturer would have to repeat significant portions of the bench testing, including biocompatibility, shelf life, etc.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 14-Oct-2020 06:58
From: Richard Vincins
Subject: MDR procedure packs--Article 22 vs. 52

Hello,

There was a similar thread asked about this recently.  I did this a couple times with "bulk" already CE Marked products put into an overall kit out of convenience and special configuration needs of the physicians.  In one case, the Notified Body would not accept "loose" items and we had to CE Mark the entire kit, maintain the technical documentation, and there was a lot of discussions around ensuring already finished medical devices were identified as suppliers in our QMS.  Keep in mind this was pre-Own Brand Labelling issues, so we did not have to worry about having access to the technical documentation for each of the devices though I imagine now under the EU MDR this will be expected (or required).  Because they would not allow us to have loose items in the kit, we had to individually label each "component of the kit" or each of the finished medical device with minimum information like the CE Mark, part number, expiration date, etc.  Then in the IFU we had to list all the devices in the kit along with the original manufacturer.  Another instance where we did this, the Notified Body was ok as long as each medical device was listed on the outside packaging kit what was in the kit.  We still only CE Marked the overall kit (example I provided earlier), but internal to the company we had to have the full traceability of each of the component/finished devices in the kit including CE Certificate, original Manufacturer, contract/agreements, and any other technical information like shelf life.  Long story ... which would take many rows or text ... shortly it was quite complicated, but the important thing is discuss this with your Notified Body and gain their acceptance to the process.  It seems each treats this differently so you want to make sure they are in agreement with the identification, traceability, CE Marking, and access to technical documentation for all the devices in the kit.  Under the current EU MDR, I would imagine if you are taking loose/bulk products and putting them together, most Notified Bodies would view you as the legal Manufacturer with all regulatory responsibility for the kit since some would view products not in their individual packaging would be a modification (especially if you are sterilising the kit after putting everything together).

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Oct-2020 10:10
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!

Dear Anonymous,

there is a little lack of information. ....... I once participated in an project, were we did a clean repackaging (no sterilization) and addressed it by a tailored IFU which explained the content  and which did identify the responsible manufacturer. It all depends (in my view) that your risk management yields an acceptable risk and that non of the products original intended purpose is altered.

This was under MDD with the related article 12 declaration and no summative, new CE mark. 

------------------------------
Uwe Zeller | Regulatory Affairs / Risk Management Consultant
Biberach an der Riß, Germany
------------------------------

Original Message:
Sent: 13-Oct-2020 10:10
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!