UKCA - Placing on the market after CE certificate has expired

#1
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
 
Elsmar Forum Sponsor

EmiliaBedelia

Involved In Discussions
#2
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
 
#3
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
#4
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

Involved In Discussions
#5
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.
 
#6
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
#7
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.
 
Thread starter Similar threads Forum Replies Date
S MDD CE Marking & UKCA Marking UK Medical Device Regulations 2
Newbie22 UPDATE UKCA; UK 12 month extension (Future regulation of medical devices - extension of standstil period) UK Medical Device Regulations 4
M UKCA EU Medical Device Regulations 5
E UKCA for devices already placed on the market UK Medical Device Regulations 16
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
S UKCA transition Medical Device and FDA Regulations and Standards News 3
G Technical documentation for UKCA UK Medical Device Regulations 4
S Need clarification on UKCA and "Approved Body" UK Medical Device Regulations 7
G UKCA and EU MDR marking UK Medical Device Regulations 5
P Declaration of Conformity for UKCA UK Medical Device Regulations 14
H Brexit Regarding differentiation of CE & UKCA CE Marking (Conformité Européene) / CB Scheme 8
J UKCA direct marking implementation UK Medical Device Regulations 0
S Clinical trial requirements for UKCA mark in UK UK Medical Device Regulations 4
R CE and UKCA marking Own Brand products CE Marking (Conformité Européene) / CB Scheme 0
Q Is it worth already getting UKCA? UK Medical Device Regulations 2
S Placing a calibration sticker with someone other than your initials Records and Data - Quality, Legal and Other Evidence 8
M Sample record for verification performed by importers before placing a device on the market EU Medical Device Regulations 0
R SaMD - Placing on the Market before DoA EU Medical Device Regulations 2
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
R RoHS and placing on the market in Non EU countries RoHS, REACH, ELV, IMDS and Restricted Substances 3
C Medical Device Marketing vs. Placing Product on the Market EU Medical Device Regulations 8
C What is "Placing on the Market" in EU? Brochures or Install? CE Marking (Conformité Européene) / CB Scheme 6
G Placing a dollar value on our QMS (we are looking at IP protection) Quality Manager and Management Related Issues 3
C Reducing paperwork and placing in Systems electronically - Electronic documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Automated Processing and Placing Parts Manufacturing and Related Processes 4
J How can I evaluate a new supplier prior to placing an order? Supplier Quality Assurance and other Supplier Issues 7
A Ownbranding or placing on market without CE mark ISO 13485:2016 - Medical Device Quality Management Systems 7
S Medical device other market Medical Device and FDA Regulations and Standards News 1
N Software update after placed on the market Medical Device and FDA Regulations and Standards News 2
B Registries for post-market surveillance EU Medical Device Regulations 0
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
J Regulatory path to enter EU market for non medical 60601 component Other Medical Device Regulations World-Wide 2
L Parabiotics on the US market Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
B U.S. market US Medical Device Regulations 3
A Post-market Clinical Follow-up Other Medical Device Related Standards 3
S Post Market Surveillance Report (PMSR) for Medical Devices EU Medical Device Regulations 6
A SaMD: Post Market Surveillance after Decomissioning EU Medical Device Regulations 2
MaHoDie Summative Evaluation with Post-Market Data? Human Factors and Ergonomics in Engineering 2
I Post Market Surveillance Process EU Medical Device Regulations 3
E Placed on the market when distributed? UK Medical Device Regulations 2
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 6
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 9

Similar threads

Top Bottom