SBS - The Best Value in QMS software

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

#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?
 
Elsmar Forum Sponsor

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
 
Thread starter Similar threads Forum Replies Date
shimonv MDR transition checklist EU Medical Device Regulations 0
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 9
T MDR Guidance Book - Useful for MDR transition? EU Medical Device Regulations 1
Ronen E Transition to MDR (EU 2017/745) - I'd like to make an offer EU Medical Device Regulations 12
L REACH compliance with MDR EU Medical Device Regulations 1
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 1
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 2
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 1
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 0
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
Ed Panek MDR Liability Insurance EU Medical Device Regulations 1
S MDD to MDR - Tallow Derivatives Impact EU Medical Device Regulations 1
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
C MDR Classification Rule 10 EU Medical Device Regulations 13
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1
K Re-packaging under MDR EU Medical Device Regulations 3
Ed Panek Upcoming NB MDD ---> MDR Crunch EU Medical Device Regulations 0
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
N Looking for a recommendation for an EU MDR Importer EU Medical Device Regulations 1
JoCam Rental and MDD versus MDR EU Medical Device Regulations 1
A Can anyone share a Distribution Agreement template under MDR 2017/745? EU Medical Device Regulations 0
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0

Similar threads

Top Bottom