Maria Donawa interviewed by MEDTECH INSIGHT

Donawa Lifescience President, Maria E. Donawa, M.D., has been interviewed by Amanda Maxwell of MEDTECH INSIGHT on the subject of European medical device guidance document MDCG 2024-3 concerning clinical investigation plans in the journal dated 8 April 2024.

The guidance, full title ‘Guidance on the content of the clinical investigation plan for clinical investigations of medical devices,’ has caused some controversy because it takes a significant amount of information, often using the same wording, from the international standard ISO 14155:2020, ‘Clinical investigation of medical devices for human subjects, good clinical practice.’

Many believe that as the ISO standard is considered ‘state of the art’ for clinical investigations of medical devices, the MDCG guidance should have made reference to the requirements of the standard, rather than transposing several sections of the standard into ‘guidance’.

Access to the interview on the MEDTECH INSIGHT website is limited to subscribers to the journal, but can be accessed here.