Medical devices, governed by the Medical Devices Directive No. 93/42/EEC (MDD), are divided into four groups based 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 are to be marketed. The Directive defines and applies different administrative requirements to four classifications of medical device. These classifications are based on the risk a specific device presents to the public and the environment.
We offer the following services:
- Understanding the data requirements and procedures to be followed to place medical devices on the markets
- Take different national requirements into consideration where relevant
- Assistance in solving borderline cases in case of doubt
- Facilitation of communications with the authorities in the pre- and post-submission phase