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Feasibility study and gap analysis, two supporting tools for medical device manufacturers

Medical devices are a wide range of products used in the medical field for diagnostic or therapeutic purposes, including syringes or patches as well as pacemakers, X-ray machines, nasal sprays, eye drops and ingestible devices.

The legal definition of a medical device is established at European level by art. 2.1 of Regulation (EU) 2017/745 (MDR), that is applicable as of 26/05/2021.

However, because of the great heterogeneity of this category of products, categorizing a product as a medical device is not always as intuitive and immediate as it may seem at a first glance.

In fact, there are several products that cannot be easily connected per sé to a specific sector, and for which it is therefore difficult to establish the reference regulation to be applied. These “borderline” products may actually fall into the definition of medical device as well as of medicine, cosmetic product, biocidal product, food supplement, PPE or other.

It is therefore essential for a company that has developed a product, potentially a medical device, to be reasonably certain of its appropriate legal frame before starting the burdensome certification process.

In fact, the MDR introduces a series of novelties in the medical device sector, significantly affecting many aspects of the product management, including post-market surveillance, quality management system, conformity assessment, clinical evidence and traceability.

The feasibility study

In order to prevent any waste of time and resources, it is essential to carry out a preliminary evaluation of the product to define its legal framework appropriately.

Once it has been established that it is a medical device, it is necessary to identify the more appropriate risk class, since this classification can affect the type and frequency of the update of the requested documents and he conformity assessment procedure required.

Among other new requirements, the MDR provides for the obligation to provide scientifically valid rationales supporting the categorisation as medical device as well as its classification.

Performing these activities is not only useful in the initial phase but it also allows the availability of information ready to be used on a second stage for the technical documentation.

This evidence is to be provided not only in case of new products, but also for those medical devices that are already marketed according to Directive 93/42/EEC (MDD) formerly in force, as well as permitted by the transitory provisions of the (legacy devices), to be transited to the regulation currently effective.

In fact, for the legacy devices it is also required to provide evidence that the relevant product is a medical device.

The leading tool to perform such preliminary assessment is the feasibility study. This consists in performing an analysis assessing different aspects of the product, such as its technical specifications and composition, its mechanism of action, its intended use and the available clinical evidence, according to the requirements established by the MDR and by other applicable regulations and based on the scientific literature.

At the end of the feasibility study, it will be possible to understand whether the product can be qualified as a medical device (and in this case which risk class it belongs to).

Such examination could also raise some critical issues that have to be solved providing further studies or tests or other kind of supporting evidence before being able to establish that the concerned product is indeed a medical device.

The performance of this kind of study at the appropriate time will allows company to budget and plan all necessary resources, costs and time to reach the marketing without any unnecessary and unpredictable losses and delays.

The gap analysis

As already said, the MDR introduces important novelties compared to the MDD, thus imposing a notable commitment also for legacy devices manufacturers that have to perform the transition of their products to the Regulation.

Since this transition to the Regulation is inevitable, before submitting a MRD certification application, it is essential to identify critical issues and deficiencies in the documentation to ensure a rapid and effective transition to the new regulatory frame.

For manufacturers finding themselves in this situation, the gap analysis is a useful and effective tool.

This analysis consists in evaluation the current status of the product certified according to the MDD with the aim of identifying any lack in the available documentation compared to the new legal requirements, indicating at the same time the type of evidence, documents or other to be processed and/or integrated in order to solve the inconsistency.

For instance, a gap analysis can be carried out on the whole technical dossier or on a part of it or on the quality management system.

The gap analysis highlights the critical issues where one can intervene and clearly and specifically defines all activities to be carried out to meet the requirements in force.

Therefore, those manufacturers that need to transit their medical devices from the MDD to the MDR, the gap analysis is an excellent starting point to define a the more suitable and effective company strategy to obtain the MDR certification.

Di Renzo regulatory affairs can perform feasibility studies, gap analysis, drafting and revision of technical dossiers and provide other consulting regulatory services in the field of medical devices. It is also possible to get a preliminary idea of the status of one’s own products in view of the transition to the new regulatory framework, filling in our dedicated questionnaire.

Written on 30/01/2024 by Simone Pippa