Hello: In my company we are developing a medical device similar like an aberrometer. We after read a lot of times the MDD 93/42/ECC we thought that our device will be a class I with measuring function. So, we started the electric and mechanical tests for ISO 60601-1 with SGS as notified body. SGS did inform us that we need to audit the ISO 13485 and the technical file, and in that way we can get the CE mark with the number of the agency. But we did contact with TÜV too, and they suggest that we can auto-certificate the technical file. Our dude is what is the correct way? The final CE mark is the same in both ways? I doubt it. And the last one is, for the AEMPS, the CE mark obtained with auto-certificate is valid to obtain the manufacturing license? Thank you.