In the context of European legislation (Medical Devices Regulation, MDR), Amsterdam UMC must properly register all medical devices developed or modified within Amsterdam UMC for use in patient care*. Software with a medical purpose** must also be registered. The registration makes it possible to assess whether the European requirements for 'in-house development and adaptation' are met. To be able to release the medical device for use in patient care, it is checked whether:
• the development process leads or has led to a safe medical device
• the documentation and the final medical device comply with the European legislation
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).
How?
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 à Meldingen à Nieuwe melding à Meldformulier in-huis vervaardigen.
Questions?
Please contact the medical device helpdesk via: adviesmedischehulpmiddelen@amsterdamumc.nl.
More information
Relevant Amsterdam UMC policy documents:
- For the development of medical devices and software with a medical purpose: In huis ontwikkeling medische hulpmiddelen patiëntenzorg
- For modifying an existing medical device: Afwijken van voorschriften fabrikant.
- For clinical investigations with medical devices: Clinical Investigations with medical devices
* Examples of in-house developed medical devices
• Patient bubble: aid for the patient to call a nurse in the absence of hand function.
• Drill/saw guide: Patient-specific tool to indicate the position and angle at which to cut through a bone.
• IVF transport box - heating block: for the conditioned transport of egg cells to another hospital.
• Drill guide: navigated drill guidance and biopsy needle guidance for taking a biopsy from suspected tumor tissue.
• Adjustable holder: tool to fix (echo) probes exactly in position.
• Maddox cross: ophthalmological measurement set-up for measuring strabismus angles.
** Examples of in-house developed software with a medical purpose
• An app for calculating the dose of medicines.
• A smartwatch app for warning of arrhythmias.
• An app with specific lifestyle advice for diabetes II.