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  • Writer's pictureLihi Levin

The Impact of the Medical Device Regulation on Writing the Clinical Evaluation Plan

Important changes in the recent Regulation (EU) 2017/745 (MDR) mean that manufacturers now need to modify how they write their Clinical Evaluation Plan (CEP) by providing new and unique specifications that apply to their device(s). Here are three fundamental changes that need to be addressed when writing the CEP.

1. More exact definitions of certain terms

In the recent MDR, it now states:

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

Before writing the clinical evaluation report, the MDR asks manufacturers to define the parameters that are used to evaluate the clinical outcomes of studies. According to these parameters, the manufacturer should determine, after analyzing all applicable data, the device's clinical benefits.

2. Continuous reporting of the methods used

In the recent MDR, it now states:

"a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects."

The MDR asks to be informed about the way the manufacturer examines and defines the devices’ clinical risks. These methods can include a strategy for collecting data, a research protocol, instrumentation used and follow-up time. The manufacturer also needs to include the manner of analyzing the data and identifying clinical safety aspects.

In the recent MDR, it now states:

"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 the intended purpose or purposes of the device."

Again, the MDR requires not only a definition but for the methods to be used in the process. For this section, the manufacturer needs to determine the parameters to be used for the evaluation of the device's benefits and risks to set the benefit/risk profile. These parameters should consider the state of the art data (e.g. competitors and other therapeutic options).

3. Writing a clinical development plan

In the recent MDR, it now states:

"a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria."

The Clinical Development Plan is a new element that necessitates the manufacturer to review the history of the studies that were done on the product—starting from bench tests, through to animal trials, clinical trials and up until post-market clinical follow-up (PMCF) studies.

It is vital to incorporate all the modifications to the MDR into regulatory documentation. Cliniture can be of assistance in this area so manufacturers can trust that all regulatory requirements are met on time by a trusted team of experts.

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