IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC

D

dchinny

Registered
#1
#1
Dear Community
Is it correct that:
> All components/accessories within an IVD (98/79/EC) Kit require CE mark in their own right?
> and that as soon as the OEM device (component) is re-labelled, the re-labeller/packer then take responsibility of the product and becomes the legal manufacturer
> does this then mean that the re-labeller/packer needs to develop separate Technical Files for each device and/or have in place a written agreement with the OEM for access to TF
> and that the re-labeller must assign a UDI to each component
> finally, is possible that while the final assembled system will contain individual CE marked devices, the assembled kit itself will not need to carry the CE

Thank you for your input
 
SQCpack - Address Quality Issues Before They Become Problems
Elsmar Forum Sponsor
chris1price

chris1price

Trusted Information Resource
#2
#2
I am sure there are different ways of doing this, but in my experience, the reagent, controls and calibrators (as appropriate to the product) will all have separate entries on the DoC, so separate CE Marks and also separate UDIs. The complete kit, ie a pack made up of all the components, would not have a CE Mark.

I can't comment on the relabeler/packer, This may vary on agreement you have with them.
 
D

dchinny

Registered
#3
#3
Thanks Chris, that's pretty much as I thought. A company has asked for some input for a product they are just about to go to market with before I flagged up the supply chain and labelling issues. thanks for being my bouncing board on this one
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 10
M IVD (in vitro diagnostic) Registration in Argentina Registrars and Notified Bodies 1
Q RUO (Research Use Only) vs. IVD (In Vitro Diagnostic) - Differences EU Medical Device Regulations 6
L Hospital Laboratory IVD (In Vitro Diagnostic) Transportation Classification in Brazil Other Medical Device Regulations World-Wide 2
I IVD (in vitro diagnostic) Checklist for ISO 14971:2009 Annex H ISO 14971 - Medical Device Risk Management 3
W Insulation Grade for In Vitro Diagnostic (IVD) Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Comparative Study - 510(K) IVD (in vitro diagnostic) Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S IVD (in vitro diagnostic) Regulations in Srilanka Other Medical Device Regulations World-Wide 10
G IVD (In Vitro Diagnostic) MDD (Medical Device Directive) Borderline Issues EU Medical Device Regulations 3
L Canadian Medical Device and IVD (In Vitro Diagnostic) Requirements US Food and Drug Administration (FDA) 3
sagai In Vitro Scanner Device (IVD) FDA Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R IVD Label Change China Medical Device Regulations 0
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
D IVD Accuracy and Precision Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 1
K Brazil (INMETRO) for Medical Electrical and IVD Equipment? Other Medical Device Regulations World-Wide 0
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
S CE Marking components within IVD CE Marking (Conformité Européene) / CB Scheme 0
B IVD - GSPR checklist Other Medical Device Related Standards 0
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
T CE-IVD mark on packaging EU Medical Device Regulations 1
A Is computing Hardware part of the IVD CE Marking (Conformité Européene) / CB Scheme 3
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
B Looking for SSCP file of IVD devices EU Medical Device Regulations 7
B Research Use Only (RUO) IVD Medical Devices in China China Medical Device Regulations 2
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
Y Handbook recommended lightcycler for IVD Risk Management Principles and Generic Guidelines 1
S IVD Device History Record ISO 13485:2016 - Medical Device Quality Management Systems 5
J IVD sampling sizes for buyer Reliability Analysis - Predictions, Testing and Standards 0
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 5
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
J IVD registration renewal in China China Medical Device Regulations 6
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
G CE marking of MD and IVD set EU Medical Device Regulations 3
D List A IVD - Change to material supplier EU Medical Device Regulations 3
J IVD instrument as an accessory EU Medical Device Regulations 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
H Incomplete IVD kit under IVD Regulation EU Medical Device Regulations 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
samarth IVD manufacturer and service provider ISO 14971 - Medical Device Risk Management 2
J Universal Power Cord with Adapters - IVD IEC 61010-2-101 CE Marking (Conformité Européene) / CB Scheme 6

Similar threads

Top Bottom