Essential Requirement Checklist For Medical Device

[anpun]

Hello,

Maybe I am asking you a very basic question about the CE Marking. But as I am new in this process, I have some doubt related to the Essential Requirement Checklist. I am preparing the Essential Requirement Checklist for the Medical Device Class IIb product. I have found the required standard for my device. My question is How could I find the test applicable for my device?? Is there any way by which I can find the test required for my device?? what is the easiest way to find the applicable tests for device???
I have asked this question to some people they suggest me, you just need to provide the applicable standards to the testing agency they will decide which test is applicable for your machine. is it the right way?

I would really be appreciated if someone helps me on this topic.

 

[BhupinderSinghPawa]

For an equivalent / predicate / similar device in the market, look at the FDA 510(k) - it provides inputs on standards used for verification and validation of the product, a good starting point.

Evaluate from the list of harmonized standards, the standards applicable -
Medical devices - European Commission

Apart from that you can also look at ISO / IEC / ASTM / AAMI / ANSI standards site for any further applicable standards for the product category.

Very common applicable product standards are as below, a brief list to start search -
EN ISO 14971 - Risk Management
EN ISO 10993 - Biological evaluation
EN ISO 60601-1 - Electrical Safety and Performance
EN ISO 60601-1-2 - EMI / EMC
EN ISO 60601-1-8 - Alarms
EN 62366 - Usability
EN IEC 62304 - Software
EN ISO 780, 980, 15223 - Symbols for Labels and Packaging
EN 11135 for EO Sterilization - and associate standards it asks for

For Class IIb you will need to have NB product audit - you may also discuss applicable standards with them during audit planning - as they anyway will determine list of standards for compliance as part of audit.

 

[anpun]

Thank you Bhupinder for your valuable input...

Is it possible to send the applicable standard to test conducting agency and they will tell me which test need to be required for conforming my device???
Cause I have the list of standard with me which are applicable for the device, but it is difficult to identify which test is required to conduct for my device??

 

[yodon]

Yes, an accredited, internationally-recognized test lab will be very helpful in identifying ALL the standards to which your device must comply and that they can test. If you're intending to market in multiple countries, they can also help identify any country-specific requirements.

 

[anpun]

Thanks, Yodon...