EU Regulations for OTS and System (Monitors and Scanner)

QAengineer13

Quite Involved in Discussions
#1
I need some guidance on EU Regulations that needs to be met if the system is combination of monitors and scanner with a medical device software that is installed on these Off the shelf hardware components.

My current thinking is that these monitors need to comply with LVD, EMC, RoHS, REACH, ErP, WEEE * Packaging waste for the EU CE mark.

The part I need some clarity is that the System is Classified as IVD but the OTS components comply to LVD, so need to understand whether the EMC requirement needs to be met for the ITE or for the Lab equipment?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
You need to start with a clear statement of what is being placed on the EU market / put into service. That entity will be subject to the regulations. Its component elements should be treated as such.
 

shimonv

Trusted Information Resource
#3
The part I need some clarity is that the System is Classified as IVD but the OTS components comply to LVD, so need to understand whether the EMC requirement needs to be met for the ITE or for the Lab equipment?
Hi QAengineer13,
You didn't give much information to go on (like Ronen wrote), but from what I gather the EMC test that you plan to do needs to meet the IVD requirements because you are using the OTS components for IVD application; its ITE certification is not applicable for the intended use you have it mind.

Shimon
 
#4
The OJ for the IVDD shows that EN 61326-2-6 is the harmonised standard for IVDD EMC.
EN 61326-2-6:2006
Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
 
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