In this video the major changes of the MDR compared to the current laws for clinical investigations with medical devices with respect to the review and conduct of clinical investigations is highlighted.
Transcript:
In this video, I would like to highlight the major changes of the MDR compared to the current laws for clinical investigations with medical devices with respect to the regulatory submission in the Netherlands, review and conduct of clinical investigations.
The 4 key changes of the MDR are:
The definition of a medical device is slightly altered.
The classification rules have been changed, allowing some medical devices to be placed into a higher risk class as described in annex 8 of the MDR
The requirements for obtaining a CE mark are higher which may result that more clinical data is needed as described in article 61 of the MDR.
The MDR describes different legal frameworks for clinical investigations depending on the purpose of the investigation.
