SBS - The Best Value in QMS software

CE Marking and Brexit - Product shipped to a distributor prior to the March deadline

JoshuaFroud

Involved In Discussions
#1
Hello Wonderful People

We are currently, along with many other manufacturers, trying to get in place Brexit preparations.

My question relates to the validity of CE Marks. At what point is that CE "set in stone" and maintains its validity? As I understand it, our devices that exist on the market and are installed with a CE mark does not lose that CE mark as at the time it was produced it could be legally CE Marked.

We have stock available in the UK we can ship to our distributor within the EU prior to the March deadline, this will be CE marked at the point of shipping to the distributor. Is it still acceptable to then sell this device as CE Marked after the deadline? The CE certificates and markings will have been applied/generated prior to any deadlines.

Please let me know your thoughts?
 
Elsmar Forum Sponsor

L_O_B

Involved In Discussions
#2
Hello Joshua,

please have a look at this document issued by the European Commission.

"1. Goods physically in the distribution chain or already in use in the EU-27 market on the withdrawal date.
Example: a cosmetic product held in the EU-27 by a wholesaler with a view to onward distribution or already on the shelf of a department store; an X-ray machine (medical device) certified by a UK Notified Body held in the EU-27 by a wholesaler or already supplied to a hospital in the EU-27, where it is in use.
These goods are considered as placed on the Union (EU-27) market before the withdrawal date and can therefore continue to be made available in the EU-27 market or remain in use with no need for re-certification, re-labelling or product modifications. This is without prejudice to the obligation to appoint a new 'responsible person' established in the EU-27 where the current one is UK-based as set out under Section B below."
 

JoshuaFroud

Involved In Discussions
#3
Thank you! I have obviously missed that publication. That has answered all of my questions.

Is there some kind of mailing list you are aware of to receive updates like this?
 
Thread starter Similar threads Forum Replies Date
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
F Lithium polymer battery, venting and CE Marking CE Marking (Conformité Européene) / CB Scheme 4
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
S CE marking for OEM Brand CE Marking (Conformité Européene) / CB Scheme 11
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
A Is it mandatory to obtain ISO13485 certificate prior to CE marking? EU Medical Device Regulations 8
G CE marking of MD and IVD set EU Medical Device Regulations 3
M CE marking for NON-EU EU Medical Device Regulations 0
NDesouza Getting Rid of Part Marking Errors Benchmarking 40
S CE marking for a product upgrade CE Marking (Conformité Européene) / CB Scheme 0
P CE Marking UK Membership CE Marking (Conformité Européene) / CB Scheme 1
J Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals CE Marking (Conformité Européene) / CB Scheme 4
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
A EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Clinical investigations of medical devices - not for CE marking EU Medical Device Regulations 0
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
Ed Panek Is Shelf Life Change a significant change? CE Marking CE Marking (Conformité Européene) / CB Scheme 7
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 6
P CE Marking EN ISO 13849-1: Electrical Panel behind interlocked doors CE Marking (Conformité Européene) / CB Scheme 9
M Cleaning Process after laser marking on orthopaedic implants Other Medical Device and Orthopedic Related Topics 3
H Safety and efficacy study for CE marking CE Marking (Conformité Européene) / CB Scheme 1
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
J CE Marking for vibrator personal pleasure toy CE Marking (Conformité Européene) / CB Scheme 17
E Safety work instruction if the equipment have the CE Marking and a Manual with safety instruction Various Other Specifications, Standards, and related Requirements 16
Z Direct Part Marking (DPM) requirements for Class II Medical Devices Manufacturing and Related Processes 0
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0
J Virtual Manufacturer and CE Marking EU Medical Device Regulations 8
N CE marking for distributed product CE Marking (Conformité Européene) / CB Scheme 1
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
J Class 1 CE Marking - Can this be removed from the label on the product? CE Marking (Conformité Européene) / CB Scheme 4
I Tool Control Marking Voiding Warranty AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158 Other US Medical Device Regulations 2
K UDI Direct Marking Compliance Date Clarification and one other UDI question Other US Medical Device Regulations 0
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4

Similar threads

Top Bottom