Medical devices, regulated by Medical Devices Directive No. 93/42/EEC (MDD) divides the devices into 4 groups, depending on their hazard potential. The MDD has a very wide scope, and it is important to understand the purpose of use and the way the products will be marketed. The Directive defines and applies different administrative requirements to four classifications of medical device. These classifications are based on the risk a device presents to the public and the environment.
Our team can help you:
- Understand the data requirements and procedures to be followed in order to place medical devices on the markets
- Take different national requirements into consideration in cases where relevant
- Help you solve borderline cases in case of any doubts
- Facilitate communications with the authorities in the pre- and post-submission phase