UKCA - Placing on the market after CE certificate has expired

Newbie22

Starting to get Involved
Hi everyone :),

I'm new to this forum and the MD industry, and have joined this forum in hope to learn more about this topic.

I have a few questions that I can't find any solid answers to online, specially since the new regulation has not been published yet.. Hence, why I created this new thread.

I was discussing with my friend in regards to existing MDs under the old EU MDD 93/42/EEC that are sold into the GB market. We are both aware that any new MD sold into the GB market under any EU legislation (both MDD and MDR) will only be recognised in the GB until June 30th 2023. Following this date all new MD must comply to the UKCA mark (The Medical Devices Regulations 2002 (SI 2002 No 618, as amended).

1. My first question is what occurs to MD already circulating the GB market after this date? does the legal manufacture/importer have to recall all their devices under the MDD/MDR after June 30th 2023? e.g. if they have not transitioned to the UKCA yet..

2. If the legal manufacture MDD Conformity Assessment Certificate expires in April 2023, can the products (produced before April 2023) still be transferred to the UK importer following the expiration date? (e.g. can provide invoices supporting this) until a new UKCA certification?

If Q2.) is a Yes... Is it even worth having these MD sent to the UK importer? since their Conformity Assessment Certificate has expired? hence, in-compliant?

Thanks :)

T
 

EmiliaBedelia

Quite Involved in Discussions
1) Devices that are already on the market are out of scope. You do not have to recall if it is already out.

2) No, the devices need to be placed on the market prior to the expiry date of the MDD cert
 

Newbie22

Starting to get Involved
1) Devices that are already on the market are out of scope. You do not have to recall if it is already out.

2) No, the devices need to be placed on the market prior to the expiry date of the MDD cert

Thank you Emilia for your prompt response :)

Is 2) still a No - if the device has already been sold in the GB market before the expiration date? (sorry forgot to add this to the question^)

Thanks,

Tess
 

CharlieUK

Quite Involved in Discussions
Thank you Emilia for your prompt response :)

Is 2) still a No - if the device has already been sold in the GB market before the expiration date? (sorry forgot to add this to the question^)

Thanks,

Tess
CE and UKCA marking, and certification, applies to each and every individual device
 

EmiliaBedelia

Quite Involved in Discussions
Thank you Emilia for your prompt response :)

Is 2) still a No - if the device has already been sold in the GB market before the expiration date? (sorry forgot to add this to the question^)

Thanks,

Tess
Yes.
The important thing to note is that "placed on the market" applies to each specific device, not the product model/version in general.
Eg, if I have an MRI machine that I have been selling since 2012, and I ship one to the UK today, its "placed on the market" date is the date that it enters the UK market (October 21, 2022) not the first date that I ever sold that device (Jan 1, 2012).

There is some complexity about "transfer of ownership" and what really constitutes "placed on the market" which you can look into in more detail with respect to your specific distributor arrangement, but that is the gist of it.
 

Newbie22

Starting to get Involved
Yes.
The important thing to note is that "placed on the market" applies to each specific device, not the product model/version in general.
Eg, if I have an MRI machine that I have been selling since 2012, and I ship one to the UK today, its "placed on the market" date is the date that it enters the UK market (October 21, 2022) not the first date that I ever sold that device (Jan 1, 2012).

There is some complexity about "transfer of ownership" and what really constitutes "placed on the market" which you can look into in more detail with respect to your specific distributor arrangement, but that is the gist of it.


Thank you so much for clarifying this, I really appreciate it! It now makes a lot more sense!! :)
 

Weeder

Involved In Discussions
Our CE marking for a device will expire soon and we are not moving to the MDR. I am trying to find out what are the obligations of a US manufacturer for supporting such device/customer. Is there any guidance available on what kind of support can be provided and what is not permitted? For example, can you do software upgrades? Will appreciate any help in this regard.
 
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