All medical devices that are developed or adapted within Amsterdam UMC for patient care or for scientific research must be registered. If you have developed or adapted a medical device, please read here below what you need to do.
Who must register?
All employees at Amsterdam UMC who develop or adapt a medical device must register this device. Medical devices that are developed and used in clinical investigations must also be registered. An abbreviated procedure applies to the latter category, a so-called Investigational Medical Device Dossier (IMDD) is sufficient, because the assessment takes place via the Medical Research Ethics Committee (MREC).
Use this convenient report form in K2 to register your medical device. (Note: link only works when K2 has been opened before). This makes the registration process as easy as possible and steers the process in the right direction. You can also reach this form via: K2/Meldingen/Nieuwe melding/Meldformulier in-huis ontwikkeling.
Please contact the medical device helpdesk via: email@example.com.
Check this intranet page for more information (in Dutch).