MDR Article 16 Certification of Distributors by a Notified Body?

#1
Hi!

New to this forum, found a lot of useful info by searching but nothing specific to our issue.

Case study: Recently established small family business, primarily focused on distributing a Class IIa medical device in Scandinavia. The product is certified according to MDD until 2024 and thus is a legacy device, currently marketed in other member states. According to the MDCG 2021-25 Guidance on legacy devices, most of the MDR regulations don't apply to distributors of legacy devices, in particular the Article 16 regulations. However, the manufacturer is currently working on the MDR re-certification of the device and thus we as distributors would also be required to follow the complete MDR regulations within about 2 years.

According to the MDR Article 16(4) and MDCG 2021-23 on the certification of distributors:
"... Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph 3."

This seems like a pretty big change in the MDR that distributors will need product-specific certification regarding their quality management system, issued by a Notified Body. Has anybody had any contact with a Notified Body about this process?

How about all you manufacturers out there? Has this come up in your discussions with your distributors?

Any and all comments are welcome! :)
 
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Philip B

Quite Involved in Discussions
#2
I think that Article 16 only applies where the distributor is carrying out any of the activities listed in section 1a-c. If not, then Art. 14 applies. HTH
 
#3
Thank you for weighing in! My understanding of the MDR related to distributors is the following:
  • Article 14 applies to all distributors. According to MDCG Guidance 2021-25, Article 14(2), last subparagraph and (4)-(6) apply even to distributors of legacy devices in the transition period. These sections have to do with obligations of post-market surveillance.
  • Article 16(1) highlights the cases in which distributors/importers modify a device to such a degree that they must assume obligations of manufacturers.
  • 16(2) specifies that modifications made to the packaging or the accompanying information that are necessary in order to make the device available in a member state shall not be considered modifications according to 16(1). However,
  • 16(3)-(4) specify obligations, additional to Art 14, which distributors/importers must assume if they make modifications according to 16(2).
In summary, for distributors:
- If you don't change anything on the device, only Article 14 applies
- If you translate or repackage, Article 16(3)-(4) apply as well
- If you make more significant changes, according to Art 16(1), than the obligations of manufacturers apply as well.

My interpretation is that many distributors would fall in the middle category and it is highly unclear to me how a distributor should or could fulfill the criteria set out in Art 16(3)-(4). I was wondering if any other distributors here have started to consider that.
 

Cybel

Involved In Discussions
#4
Hi, if this may help, I've included this flowchart in QTAs with my distributors. At the end, basically none of them is involved in article 16.

Do you translate IFUs/labeling by your own after the manufacturer had delivered the medical devices to you?
Do you repackage the devices (other than for logistic purpose)? flow chart art. 16.png
 
#5
Hey and thank you for your reply! Since we are doing the translating on behalf of the manufacturer our conclusion was also that Article 16 doesn't apply.
May I also ask: if Art 16 doesn't apply, what is your distributors' position on the need to establish a Quality Management System for a distributor and if they have one, how does it look like?
 

Cybel

Involved In Discussions
#6
Hey and thank you for your reply! Since we are doing the translating on behalf of the manufacturer our conclusion was also that Article 16 doesn't apply.
May I also ask: if Art 16 doesn't apply, what is your distributors' position on the need to establish a Quality Management System for a distributor and if they have one, how does it look like?
Hi, especially small distributors don't have a certified QMS but have procedures that align their quality system to a certified one (for applicable processes of course, such as control of incoming goods, identification, warehouse management, traceability, vigilance). I evaluate and periodically re-evaluate them basically the same I do for critical suppliers.
 
#7
Maybe you can help with a different question on Article 16 (1)(a). We want to do a relabeling. Can we also "delete" the manufacturer and replace it with the Importers name incl. the type of work? Such as RELABELER: Company xy? I searched the MDCG documents (2021-23 and 26) and analyzed the MDR Art. 16, but this is not clear to me.
In other words - we are looking for a smart replacement of the former OEM-PLM relationship without slipping into the role of a manufacturer with an outsourced process. The former OEM is not willing to supply the entire Technical Documentation - so this way is not possible either way.
 

Billy Milly

Involved In Discussions
#8
If you cover (eliminate) any device info (manufacturer, ref, symbols, brands, addresses...), you take on the manufactuter's responsibilities and are responsible for compliance of the device.
 

Junn1992

Quite Involved in Discussions
#9
According to MDCG 2021-023, it does seem like distributors need to be certified by a NB.

With regards to Article 16, 2(a) and 2(b), they refer to what is considered device modification under article 16 1(c). BUT it does not mean that Article 16 does not apply to the distributor. Read Article 16.1 very carefully.
 
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