MDR Transition - make "Available on the market" after CE certificate expiration

yyoossssii

Starting to get Involved
#1
Hello.

The CE MDD certificate of one of our device is expiring in December 2021. We are making some changes on the device and we are expecting to finish MDR certification of the new device in June 2022.


The question is how can we keep selling the device during the period between December 2021 and June 2022?

MDR – Article 120 – Transitional provision
2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2017 shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC which shall become void at the latest on 27 May 2022.


This our case, the device certificate is valid until December 2021.

But paragraph 4 stipulate that:
4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.
That’s mean that device “placed on the market” according to MDD prior 26 May 2021 (all dates have been postponed by one year) and/or prior to the "expiration date" could “be made available on the market” or “put into service” until 27 May 2025 (2026?).

The meaning of “placed on the market”, “made available on the market” and “put into service” is defined in MDR Article 2:

(27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;

(29) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;


A detailed definition is available on the Blue Guide. paragraph 2.3:

the manufacturer and the importer are the only economic operators who place products on the market (49). When a manufacturer or an importer supplies a product to a distributor (50) or an end-user for the first time, the operation is always labeled in legal terms as ‘placing on the market’.

So if a manufacturer wants its products to be placed on the market he should have them under the control of another entity.

One interesting part of this definition is this one:

Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question after the stage of manufacture has taken place (51). This transfer could be for payment or free of charge. It does not require the physical handover of the product.
It means that you can still have the products on your stock but officially these belong to a distributor or end customer.

Concerning building stock inside the manufacturing plant another part of the definition says:


Placing on the market is considered not to take place where a product is:
[…]

— in the stocks of the manufacturer (or the authorized representative established in the Union) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonization legislation.



Bottom line

If we produce the devices before December 2021, and we transfer the ownership to our distributor, we can keep selling the device until the new certification (or maybe even until 27 May 2025 (2026?)).

What is you opinion?
 
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planB

Super Moderator
#2
You have to place your device on the market _before_ its CE mark expires. Once you have your device CE-marked again, you can again place the the device on the market.

Hope this helps,
 

Weeder

Involved In Discussions
#4
I have a question regarding the Authorized Representative. If we are no longer placing new devices in the market, do we still need to have an Authorized Representative for the existing devices already sold to the customer?

If not, then how do we handle vigilance activities such as recalls, complaints, etc?

Is there any guidance available on this

Thanks
 
#5
Hello.

The CE MDD certificate of one of our device is expiring in December 2021. We are making some changes on the device and we are expecting to finish MDR certification of the new device in June 2022.


The question is how can we keep selling the device during the period between December 2021 and June 2022?



This our case, the device certificate is valid until December 2021.

But paragraph 4 stipulate that:


That’s mean that device “placed on the market” according to MDD prior 26 May 2021 (all dates have been postponed by one year) and/or prior to the "expiration date" could “be made available on the market” or “put into service” until 27 May 2025 (2026?).

The meaning of “placed on the market”, “made available on the market” and “put into service” is defined in MDR Article 2:



A detailed definition is available on the Blue Guide. paragraph 2.3:




So if a manufacturer wants its products to be placed on the market he should have them under the control of another entity.

One interesting part of this definition is this one:



It means that you can still have the products on your stock but officially these belong to a distributor or end customer.

Concerning building stock inside the manufacturing plant another part of the definition says:





Bottom line

If we produce the devices before December 2021, and we transfer the ownership to our distributor, we can keep selling the device until the new certification (or maybe even until 27 May 2025 (2026?)).

What is you opinion?
The requirements to me are not clear and I'm not getting any guidance from the Notified Body. My question is: If product was manufactured under a valid CE certificate and shipped to a Distributor before the CE certificate expires are they allowed to ship the product to customers? If so, where can I find this guidance or regulation?
 

Sinus Tarsi

Involved In Discussions
#6
The requirements to me are not clear and I'm not getting any guidance from the Notified Body. My question is: If product was manufactured under a valid CE certificate and shipped to a Distributor before the CE certificate expires are they allowed to ship the product to customers? If so, where can I find this guidance or regulation?
Yes, that is correct. I asked our NB about this recently since our MDD expires in June and they can't even begin to audit us for MDR until February!!! As long as the product was already in the EU prior to the CE expiring you are good. They actually suggested we stock pile inventory in our EU warehouse.
 
#7
If so, where can I find this guidance or regulation?
This is described in Article 120(4) of the MDR:

4. Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.
Paragraph 3 refers to NB certificates valid after 25 May 2021. Basically every device either placed on the market prior to 26 May 2021 or placed on the market after 25 May 2021 under a NB certificate still valid can be made available/put into service until 26 May 2025.

You have to differentiate between "Placing on the Market" and "Making available". "Placing on the market" "means the first making available of a device..." and is performed once the Legal Manufacturer or Importer (as applicable) is transferring the product to a 3rd party (e.g. the Distributor).
"Making available" is what Distributors are doing.

I hope this helps.
 
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