A new National Research Ethics Committee to review clinical investigations of medical devices, and post-marketing follow-up investigations of medical devices (NREC-MD) was set up in the Republic of Ireland on the 6 May 2021.
All NREC-MD approved studies taking place in Beaumont Hospital will be required to follow the site sign off process.
Beaumont Hospital Ethics (Medical Research) Committee
Beaumont Hospital Ethics (Medical Research) Committee can continue to review research studies which use medical device(s), including standalone software medical devices (e.g. apps), provided that the study does not fall under the remit of the NREC-MD. The key determinant used by the NREC-MD to assess whether the study falls under their remit is whether the study aims to assess the device itself, in terms of its safety or conformity.
Non-CE Marked Medical Devices
While there is no bar on researchers using non-CE marked devices in research studies, issues of insurance, indemnification and liability may arise during the site sign off process. Safety concerns may also be raised by the research ethics committee as part of its assessment of risks and benefits to research participants.
Standalone Software Medical Devices (e.g. 'apps')
Studies which use standalone software medical devices (e.g. apps) may raise safety or privacy concerns during research ethics committee review.
A wide variety of
digital health laws and regulations can apply.