Confirming IVD exemption from WEEE

A

ALICEqa

#1
Hello Cove Users,

I have a question in relation to confirming IVD exemption to WEEE.

The product I am trying to confirm exemption from WEEE is an instrument which is used in conjunction with IVD consumables for testing human serum/plasma samples. The product is general class according to the current IVD Directive.

Technically the instrument should not come into contact with the patient sample, but this risk cannot be completely excluded due to the size of the area of the patient sample port and also the users accuracy at pipetting.

From the research I have done, to me it is clear that we are exempt from WEEE as the product is has potentially come into contact with infected product. I would really appreciate if any of you could confirm this?

Thanks in advance to all who can help with this query, :)
Alice
 
Elsmar Forum Sponsor

Mikishots

Trusted Information Resource
#3
Hello Cove Users,

I have a question in relation to confirming IVD exemption to WEEE.

The product I am trying to confirm exemption from WEEE is an instrument which is used in conjunction with IVD consumables for testing human serum/plasma samples. The product is general class according to the current IVD Directive.

Technically the instrument should not come into contact with the patient sample, but this risk cannot be completely excluded due to the size of the area of the patient sample port and also the users accuracy at pipetting.

From the research I have done, to me it is clear that we are exempt from WEEE as the product is has potentially come into contact with infected product. I would really appreciate if any of you could confirm this?

Thanks in advance to all who can help with this query, :)
Alice
I'd say exempt for now, but will be recast in 2016. The exception will be very short-lived.

It's kind of a gray area, this example, because of the fact that you say it "shouldn't" come into contact with patient samples. Unless it was designed to come into contact, then....it may not be exempt. My advice would be to proceed in a manner that assumes it's not.
 
Last edited:
Thread starter Similar threads Forum Replies Date
H Positive LAL while sterility and bio burden is confirming CE Marking (Conformité Européene) / CB Scheme 3
T Confirming The Local Safety Regulations for Equipment - I'm in Malaysia General Measurement Device and Calibration Topics 1
M ISO 9001:2008 clause 7.6 - Confirming and Reconfirming Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Color Management - Confirming Color for Injection Molded Plastic Parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Using a CMM for Confirming Circular or Total Runout?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Douglas E. Purdy 7.2.2 - Confirming Order if the product requirements are not provided in writing? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Marc Getting the Most out of Internal Audits - Confirming to Innovating General Auditing Discussions 8
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 3
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 4
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
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
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
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 10
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
M PMS template for FDA submission (De novo submission for a Class II IVD) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J IVD CE transfer to another manufacturer EU Medical Device Regulations 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6

Similar threads

Top Bottom