Maria Donawa posts article on device clinical evaluation plans on LinkedIn

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘CEPs: Parameters vs outcome parameters, what’s the difference?’

The topic arises because of confusion among manufacturers, notified bodies, and competent authorities regarding the interpretation of certain requirements of the EU Medical Device Regulation (MDR, 2017/745) for clinical evaluation plans (CEPs). Specifically, in MDR Annex XIV Part A, in which there are, among the requirements listed, these two:

• a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters; and
• 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.

One interpretation is that the use of ‘parameters’ in the second bullet point means ‘clinical outcome parameters’, but dr. Donawa argues in the paper that the term ‘parameters’ is broader than just parameters linked to clinical outcomes.

The article also received top billing on the LinkedIn ‘MedTech Leading Voice‘ Newsletter published on 7 April 2024.

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