CE IVD Mark - Emission certifications for unexpensive product

[Anacardi]

Hi everyone,

Our R&D is trying to do CE-IVD marking of a class-A device. The device could be described as a miniPC, with bluetooth, wi-fi connectivity and USB connectivity.
The device would have some electronics that is derived from one of our other devices (that is already CE-IVD marked, from a third party company).
We are going to finish the testing in-house for electric and mechanical risks but for the electromagnetic emission part we have asked to an external lab.

They are asking several thousands of euros for this testing and this could kill the project since we are a small company, do you have any suggestion/experience on how to do in-house testing for:
- EMC 61326-2-6:2006/IEC 61326- 2-6:2005;
- ETSI EN N. 301489-1 V2.2.3 /-17
- EN IEC 62311: 2020

Could a derivation from past certification be done if changes have been done to the device mechanics?
Another idea we got was to make some 'difference' measurements to assess the emissions of the new devices and compare them with those of the old device. Could this kind of emissions be sufficient for CE-IVD marking?

Thank you for any help

 

[Harsh]

CE-IVD certification first of all depends on the class of IVD in which your device falls. Another thing that has a huge impact on the certification procedure is the company's location. But do note that product compliance requirements would be the same for both EU & Non-EU manufacturers.

If you are located in Europe then class A would be self-declarable & if the manufacturer is Non-European then there would be the requirement to hire an Authorised Representative Agency located in one of the European Union countries which will take all the compliance-related responsibility on behalf of your company after verifying all your compliance documents.

For information regarding the latest directives & harmonized standards, you should refer to the below-mentioned official website of the European Union.
Harmonised Standards.

The edition of the EMC standard that you have mentioned EN 61326-2-6:2006/IEC 61326-2-6:2005 is an obsolete edition of the standard for the European Union. The current harmonized edition is EN 61326-2-6:2013/IEC 61326-2-6:2012 which you can verify from the link mentioned above.

So your first priority should be to identify all the directives which are applicable to your devices & also the latest editions of the harmonized standards under those applicable directives for testing.

For the EMC testing procedure, you can refer to the applicable EN 55011 (For Emission) & 61000 (For Immunity) editions of standards mentioned in the EN/IEC 61326-2-6 standard.