The full responsibility for MDR compliance of products lies with the organizations that manufacture them.
Each product that a company creates should have an ‘intended use’ document or statement, that describes for which purposes the company intends it to be used.
The MDR lists 22 ‘rules’ that detail which characteristics of a medical device define the class it should belong in. Based on the intended use and other product documentation, the manufacturer can use these rules to determine the right class for their devices.
Self-certification vs. registration through a notified body
If the intended use and product documentation align with the characteristics of a Class I medical device, the manufacturer can certify the product themselves.
For products that should belong to a higher class (and thus poses higher risk to patients), a notified body must be involved. A notified body is an organization authorized to officially assess the conformity of products, before they are placed on the market.