The company I work for manufacturers Pilates equipment for home, studio and rehabilitation clinics. The equipment has no electronics, sterilization or measurement features its purely mechanical rollers and pulleys which I believe falls under Med. Dev. Class 1. Being Class 1 I understand that it does not need to be certified by a third party test lab but it does need to be compliant to ISO 20957-1 & 2 - is that correct? I have paid for the ISO 20957-1 & 2 standards so that I can at least see what the product has to comply with - which takes quite a bit to understand it. I know I need to create a Technical Construction File but what else do I need to do to be in compliance and put CE on the products? I also saw some regulation changes for next year MDR 2020 - does that affect Class 1 as well?