Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the medical device conformity assessment procedure. The checklist can provide an indication of the progress of this certification process.
© 2023 | Boumans Regulatory Consulting BV