Maria Donawa posts a second article on device clinical evaluation plans on LinkedIn

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a second ‘Regulatory Recap’ article on LinkedIn covering interpretational difficulties with requirements for Clinical Evaluation Plans (CEPs) under the EU Medical Device Regulation (MDR, 2017/745) titled: ‘CEPs: What Does “State of the Art” Modify?’

The topic arises because of confusion among manufacturers, notified bodies, and competent authorities regarding the interpretation of certain requirements of the MDR for clinical evaluation plans (CEPs). Specifically, in MDR Annex XIV, Section 1(a) 6th indent, it requires that the CEP includes:

“an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device.”

The question is: Does “state of the art” modify “parameters” or “the acceptability of the benefit-risk ratio?”

Dr Donawa concludes, following a grammatical analysis of the text, that “based on the state of the art in medicine” applies to “the acceptability of the benefit-risk ratio” rather than “parameters”, identifying that this interpretation is entirely consistent with MDR Annex I GSPR 1, which mandates that the generally acknowledged state of the art is taken into account when determining the benefit-risk ratio.

The article also received top billing on the LinkedIn ‘MedTech Leading Voice‘ Newsletter published on 9 September 2024.

A copy of the article can also be downloaded from the ‘Publications’ section of this website.