Are small companies or low risk class devices exempted from designating EU Authorized Representative?
We are a very small company, and our device is low risk, do we still need an EU Authorized Representative?
Yes, you do. It is the law. Requirement to have a designated EU Authorized Representative is regardless of the company size or the product class.
If you are a medical device manufacturer located outside of the EU, and you want to place your device on the EU market, you must have an EU Authorized Representative. There is no relief for micro or small enterprises.
It also does not matter if your product is of Class I, Class Im, Class Is, Class IIa, Class IIb or Class III, you need an EU Authorized Representative as a non-EU manufacturer if you want to place your device on the EU market.