Regulatory intricacies - tertiary packaging of class III MD

M

Munreg

#1
[FONT=&quot]Regulatory intricacies regarding tertiary packaging of class III medical devices, for distribution in non-EU Countires.
[/FONT]


[FONT=&quot] Hoping very much to solve a theoretical problem...any help and experience is much appreciated!
[/FONT]
[FONT=&quot]Scenario is as follows: [/FONT]
[FONT=&quot]- [/FONT][FONT=&quot]The manufacturer (EU based company) has been issued a new CE number due to a change in its Notified Body.[/FONT][FONT=&quot] Some tertiary packaging (folding boxes) of the devices still carry the old CE number, as the stock had not yet been depleted.
[/FONT]
[FONT=&quot]Distribution in non- EU non-GHTF countries:
[/FONT]
[FONT=&quot]Given that, the following solution is only for labelling on the folding boxes and only until the stock is depleted [/FONT][FONT=&quot]and the sicker should have a permanent nature (not easily removable). [/FONT]

[FONT=&quot]--> Can the manufacturer place a sticker of the new CE number over the old one? [/FONT][FONT=&quot]
[/FONT]

[FONT=&quot]
[/FONT]

[FONT=&quot]Any experiance? [/FONT][FONT=&quot]Thank you!
[/FONT]

[FONT=&quot]
[/FONT]
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove!

The answer depends on the country. Some non-EU countries have legal provisions that rely on CE marking and maybe on associated labelling / marking.
 
M

Munreg

#3
Thank you for such a fast response!!

Yes, it is true that a growing number of non-EU countries have legal provisions that rely on CE marking and associated labelling / marking.

The dilemma is: which countries are free enough to AND also practice their own regulations allowing marking with a semi-permanent sticker
and
The CE Marking does communicate current compliance and is correct...just the labelling of the outer box is (as an interim solution) supposed to be a sticker instead of print....

Any suggestions of literature/ lists?


Thank you again!
 
M

Munreg

#5
It is for un upcoming pannel discussion and not a happening live. Basically a sort of homework question, wherby solutions and answers are expected for upcoming discussion...
 

pkost

Trusted Information Resource
#6
You should look less at the regulation and more at the contract between manufacturer and NB. I suspect that there will be a clause there that prohibits use of their number
 
S

Sarah Stec

#7
The dilemma is: which countries are free enough to AND also practice their own regulations allowing marking with a semi-permanent sticker
and
The CE Marking does communicate current compliance and is correct...just the labelling of the outer box is (as an interim solution) supposed to be a sticker instead of print....

Any suggestions of literature/ lists?
Making a list of countries that would "allow" this may not be the best way to respond to this question. This list that you make today changes from day to day, situation to situation, and saying things like "Country X has their own regulations, but they don't monitor their labeling regulations very well so you can go ahead and sticker over the old NB number" can lead someone down a wrong path, in my opinion. Especially when the answer is probably something more like that "it depends on what the new NB and old NB allow the manufacturer to do with their number, in combination with whether the country's regulator will allow such relabeling to take place given where the product is in the import/distribution chain, and whether or not it matters in that specific country given their regulatory regime." :2cents:

Pkost has a point that the contract with the NB would dictate the conditions under which the manufacturer can use their number. Each NB will handle this in their own way. IME, the new NB needs to know how much product is going out with their predecessor's number on it for their own risk management.
 
Thread starter Similar threads Forum Replies Date
Watchcat REGULATORY WATCHCAT - His Grandmother's Technology Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Samples & Labeling Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Clinical Investigations Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - The 510(k) Submissions Tracker Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Nonclinical Studies Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Benefits and Risks Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Alternative Practices and Procedures Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Device Description Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Indications for Use Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - General Comments Other US Medical Device Regulations 2
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
P Quality and Regulatory organizational structure Consultants and Consulting 2
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT - De novo info updated and consolidated Other US Medical Device Regulations 0
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Worldwide Regulatory Knowledge Other Medical Device Regulations World-Wide 3
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 42
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 11
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
Watchcat Year of the Regulatory Watchcat Other US Medical Device Regulations 6
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 46
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
S Regulatory Medical Device PMA Plans US Food and Drug Administration (FDA) 2
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom