The provisions concerning medical devices contain manufacturers information on how to affix the conformity markings (CE markings) on the products and place them on the market.
Placing a new product on the market requires that the manufacturer has the necessary documentation for evaluation and verification of product conformity. For a product to be considered a medical device, the manufacturer must be able to demonstrate that its intended purpose complies with the definitions laid down in the regulations.
Once the product’s intended purpose has been defined, the requirements and procedures set out for the product to establish conformity must be followed. The manufacturer must, for example, define the product’s intended purpose, classify the product in the correct category in accordance with the principles laid down in the regulations, demonstrate that product requirements have been fulfilled, evaluate the product risks and present measures for their elimination.