You say you just don't do trails/evaluations... if you are selling a medical device in the EU, you do, DO trials/evaluations.
If a device is brand new and there is nothing that performances/functions in a similar manner, you do clinical trials with this device.
If you are releasing a product that is quite similar to other device and it can be proved to have the same functionality and output, then you can do a clinical evaluation of data to prove the functionality, safety; etc is as required to market the device. This has been mentioned in the above posts.
You need to get your hands on the NB-MED’s and
MEDDEV’s that have been released as guidance documents for the directive. If you don’t have them, give me a shout and I will send you the link for them.