The new European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) has entered into force May 26th 2021 (EU no 2017/745, MDR). The MDR contains specific rules for the submission, assessment and conduct of clinical research on medical devices.
Software can also be a medical device. Software is a medical device if the manufacturer (or researchers) created the software for medical use. For example, an app for home monitoring of patients with heart failure. Regardless of where the software is used: with the patient at home or in the hospital. Also check this flow chart of the CCMO and this EU factsheet.
Recently, the guideline 'Guideline for high-quality diagnostic and prognostic applications of AI in healthcare' was published (see under Download). This guideline provides a description of what the work field considers good professional conduct in the development, testing and implementation of an Artificial Intelligence Prediction Algorithm (AIPA) in the medical sector, including public healthcare.
For more information and advice:
- CCMO - Wet- en regelgeving, richtsnoeren en standaarden voor onderzoek medische hulpmiddelen | Onderzoekers | Centrale Commissie Mensgebonden Onderzoek (ccmo.nl)
- Amsterdam UMC - Medische hulpmiddelen (intranet)
- Amsterdam UMC, Locatie VUmc - Toetsing van klinisch onderzoek met medische hulpmiddelen