The classification of a medical device is the responsibility of the Manufacturer. An incorrect process of identifying the medical device and its classification can lead to incorrect decisions about pre-clinical studies to be developed or approval procedures to be applied with waste of time and resources. In Cebis we help companies to apply the classification rules unequivocally and, after a study of the medical device, we elaborate the Justification of Classification based on the indications of Annex VIII of Regulation (EU) 2017/745 and the most recent official guidelines issued by the MDCG Group.
Even if you are still in the planning stages of your project, you are more than welcome to submit a request to us. We can assist you with a quotation or create a proposal for you based on the minimum of information you can provide.
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CEBIS Interantional
Romania- Helios Business Center (HBC),
47 Bd. Theodor Pallady,
Bucharest, Romania