Medical device CE marking

European Commission publishes Factsheet for Class I Medical Devices


On April 28, the European Commission published a useful three-page Factsheet for Class I Medical Devices. It covers devices that have already been placed on the market under Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance with Regulation (EU) 2017/745 (MDR). For further information, consult MDCG 2019-15 rev.1.

The document can be downloaded in our library

Source: European Commission