When is "placing on the market"? MDD certified medical devices

Nono

Registered
#1
Our company outside of EU has decided not to renew one of the MDD certified medical devices. (No plan to renew under MDR.)
The MDD certification of the device will be expired on 15 February, 2022.

In that case, which of the following conditions will be regarded as "placing on the market" in order to sell or use the device even after the expiration date?

① Cleared customs (in EU region) by 15 February 2022
② Stored in the importer's warehouse in EU region by 15 February 2022
③ Stored in agent's or distributor's warehouse by 15 February 2022
④ Hand over to end-user by 15 February 2022

Your comment is highly appreciated.

Thanks and regards,

Nono
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
There is a difference between "placing on the market" which you have already done and "making available on the market". See this guidance
Factsheet for Authorities in non-EU/EEA States
Extract "MDs and IVDs that were placed on the market after 26 May
2020 (for MDs) or after 26 May 2022 (for IVDs) by virtue of a
valid certificate issued before that date may be made available
until 26 May 2025. After 27 May 2025, any of these devices that
have not reached the final user will have to be removed from
the supply chain.
Devices that have been placed on the market and put into service,
so that they have reached the final end user before 26 May 2025,
can continue to be used by the user. The Regulations do not cover
second-hand products (MDR/IVDR Recital 3)."

I hope this helps.
 

Nono

Registered
#3
Dear Rob73,

Thank you very much for giving very clear definition, which is helpful!

So let me rephrase my question:

If the device is still made available on the EU market after the expiration date of certification, is it possible to sell the device to the end-user? My understanding is: As long as the device is manufactured before the expiration date and making available in EU region , the device can be sold in EU region even after the date. Is it not correct?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
For a non-EU manufacturer, Placing on the (EU) Market = transfer of title from the (EU-based) Importer to their customer, regardless of who/what they are; i.e. the first transaction wholly within the EU.

After May 26, 2025, new (non-second-hand) devices are not to be further sold if they are not in compliance with the MDR.
 

Ioko

Starting to get Involved
#5
For a non-EU manufacturer, Placing on the (EU) Market = transfer of title from the (EU-based) Importer to their customer, regardless of who/what they are; i.e. the first transaction wholly within the EU.

After May 26, 2025, new (non-second-hand) devices are not to be further sold if they are not in compliance with the MDR.
Hi Ronen,

Can you please give me your reference? I thought for a non-EU manufacturer placing on the EU market was when the manufacturer transfer the unit to the importer and not when the importer transfer it to the user (in case of the importer is acting as the distributor). From my understanding, and the blue guide : placing on the market is “…reserved either for a manufacturer or an importer, i.e. the manufacturer and the importer are the only economic operators who place products on the market”.

Thank you
 

Ronen E

Problem Solver
Staff member
Moderator
#6
the blue guide : placing on the market is “…reserved either for a manufacturer or an importer, i.e. the manufacturer and the importer are the only economic operators who place products on the market”.
I think that this statement relates to a manufacturer that is EU-based.
I think I picked the definition I used for Placing on the Market from the Blue Guide, though it might have been the previous edition. Or maybe it was from the Market Surveillance Commission Decision (now being phased out). I honestly don't remember, it was years ago. I also used to think like you (the official definition is not intuitive), but then I realised I was wrong.
 

Ioko

Starting to get Involved
#7
I think that this statement relates to a manufacturer that is EU-based.
I think I picked the definition I used for Placing on the Market from the Blue Guide, though it might have been the previous edition. Or maybe it was from the Market Surveillance Commission Decision (now being phased out). I honestly don't remember, it was years ago. I also used to think like you (the official definition is not intuitive), but then I realised I was wrong.
Hi Ronen,

Apparently after few more research, for a non EU manufacturer and an Importer that is acting as a distributor, the product is placed on the market once there is a transfer of ownership from the Importer to the end user. That is my understanding now. However, this sentence from the blue guide is confusing me:

"For the purposes of Union harmonisation legislation, a product is placed on the market when it is made available for the first time on the Union market. The operation is reserved either for a manufacturer or an importer, i.e. 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 labelled in legal terms as ‘placing on the market’.
(50): The distribution chain can also be the commercial chain of the manufacturer or the authorised representative." Does it not apply for an importer acting as a distributor?

Can you please give me your thinking?

Thank you for your help!
 

Watchcat

Trusted Information Resource
#8
See this guidance
Factsheet for Authorities in non-EU/EEA States
Extract "MDs and IVDs that were placed on the market after 26 May
2020 (for MDs) or after 26 May 2022 (for IVDs) by virtue of a
valid certificate issued before that date may be made available
until 26 May 2025. After 27 May 2025
That doesn't seem to answer the question of what it means to "place on the market" after 26 May 2020, nor the equally important question of what does it mean to "make available"? It only clarifies the date on which devices that are in the hands of the end user can remain there.

Also does this mean the same rules do not apply for an EU manufacturer?
 

L_O_B

Involved In Discussions
#9
The European Commission issued an interpretative document on "placing on the market" in the context of the medical device directives:
https://ec.europa.eu/docsroom/documents/10265/attachments/1/translations/en/renditions/pdf
Indent 15 might be helpful in the context of imported devices:
"As regards imported products, they must at least be released for free circulation
in the internal market before they can be considered as being placed on the EU
market (see Articles 27-29 of Regulation (EC) No 765/2008). In particular
paragraphs 1 and 2 of Article 29 of Regulation 765/2008 state that products
which present a serious risk or which are not compliant with harmonised EU
legislation, and which therefore shall not be placed on the EU market, shall not
be released for free circulation. This requires a close cooperation between
customs authorities and market surveillance authorities.
"
 

Watchcat

Trusted Information Resource
#10
Can you please give me your thinking?
There are a number of knowledgeable and thoughtful people here in the Cove, but what you are asking for is a legal interpretation, and I would put it to an EU device lawyer. Personally, I would ask Erik Vollebregt. If you aren't comfortable asking directly, I would be surprised if he hasn't already addressed this question in his blog:

https://www.linkedin.com/in/erikvollebregt/
medicaldeviceslegal
 
Thread starter Similar threads Forum Replies Date
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
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
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
A Ownbranding or placing on market without CE mark ISO 13485:2016 - Medical Device Quality Management Systems 7
S Placing a calibration sticker with someone other than your initials Records and Data - Quality, Legal and Other Evidence 8
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
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
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 3
thisby_ Post Market/Production Risk Assessment ISO 14971 - Medical Device Risk Management 0
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
D Economic Operators, EU Market Access EU Medical Device Regulations 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R Information on obtaining a market authorization for China China Medical Device Regulations 2
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
F When to market and distribute device in EU? EU Medical Device Regulations 3
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
T Modification of a product on the market EU Medical Device Regulations 2
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
K Product (Device) Life cycle - Product Life AFTER the Post Market Phase Medical Device and FDA Regulations and Standards News 3
M Post Market Surveillance for Class II Medical Devices Medical Device and FDA Regulations and Standards News 2
H Post-market surveillance strategy EU Medical Device Regulations 2
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 10
A Post-market clinical followup studies (PMCF) EU Medical Device Regulations 16
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
E Post Market Surveillance Standard Various Other Specifications, Standards, and related Requirements 4
K EU MDD Class I Device market access / certification after 26th May 2020 EU Medical Device Regulations 9
T Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b) EU Medical Device Regulations 3
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
M Post Market Surveillance Plan Template EU Medical Device Regulations 12
F Vietnamese Post-Market Surveillance Requirements for a medical device in Japan Other Medical Device Regulations World-Wide 0
M PMCF (Post Market Clinical Followup)/ PSUR template EU Medical Device Regulations 9
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
M New medical device on the market before MDR EU Medical Device Regulations 12
M Informational The ANSM decides, as a precautionary measure, to withdraw from the market macrotextured breast implants and breast implants with polyurethane-coated s Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom