Release of a new MDCG document

In October 2022, the Medical Device Coordination Group has published the MDCG 2022-16 document “Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”.

New position paper on “off-label” data

This position paper defines the term “off-label use” and addresses whether data generated from off-label use of a product, i.e. so-called “off-label data”, may be used to expand the intended purpose/indications.

WordPress Cookie Plugin by Real Cookie Banner