MDR - STATE OF THE ART OF SUBMISSIONS, CERTIFICATION AND WASTE: THE DATA SPEAK FOR THEMSELVES

Over the last few years, with the progressive implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), a dynamic has clearly emerged that affects the entire in vitro diagnostic and medical device sector across the board: the difficulty in submitting complete submissions to the Notified Bodies for the first time.

To explore this issue, we analysed the data contained in the document 'Study supporting the monitoring of the availability of medical devices on the EU market - Survey results of the 18th NB survey (MDR/IVDR)' updated to 31 October 2025.[1]

At a first reading, the numbers describe a growing system: more applications and more certificates issued. However, a closer look at the data reveals a more complex picture, in which the real distinguishing feature is not so much the volume as the quality of the submissions and the system's ability to filter requests, transforming them into accepted applications and, subsequently, into certificates.

One must bear in mind, however, the distinction drawn by the document itself: that between 'applications lodged' and 'written agreements signed'. Applications lodged represent all applications formally sent to Notified Bodies, regardless of their outcome. This set therefore includes both dossiers that have led to certification and those still under evaluation, but also those rejected, withdrawn by the manufacturer or submitted for amendments to existing certificates. It is, in other words, a rough overall figure that measures everything that enters the system but does not necessarily continue its course or find unambiguous correspondence in the 'written agreements signed'.

Written agreements, in fact, represent the next and much more selective step: they indicate the applications that have passed the preliminary screening phase and for which the Notified Body has formally agreed to proceed with the evaluation, formalising a contract with the manufacturer. This means that not all applications automatically become certification projects.

It is legitimate to wonder at this point how mature the applications are when they enter. Of the approximately 31,863 MDR applications submitted, about 21,426 (about 67%) written agreements were signed, while rejected applications amounted to 918. It follows that a numerically significant proportion of submissions, in the order of more than ten thousand, do not even reach the contractual stage.

The high number of applications that do not make it to the contractual stage implies that a significant proportion of submissions are nevertheless analysed by Notified Bodies without being translated into certification activity. This phenomenon, although not the main cause of system saturation, contributes to absorbing technical resources and may affect the overall assessment time by the Notified Body, especially in a context already characterised by limited capacity.

Continuing our analysis, a second central element concerns the number of certificates issued. Comparing the number of certificates issued with the number of applications, another relevant aspect emerges. Against more than 31,000 applications, the total number of certificates is around 17,500. This means that about half of the applications have not yet translated into a certificate. We have no elements to fully interpret this figure, i.e. whether there are delays in evaluations or requests for integrations, but we can certainly say that the figure shows the presence of a second level of complexity, related to the time and capacity of the system to process requests.

If we look at the flow as a whole, the incoming applications represent the total volume of requests. A part of these passes the screening phase and is translated into written agreements, thus entering the actual certification pipeline. It is precisely in these progressive steps that system bottlenecks are generated, such as that between the signing of the contract and the issuance of the certificate: the longest and most complex phase. In this phase, the Notified Body plans and thoroughly examines the device's technical documentation and an iterative cycle of requests for clarification (questions or non-conformities) and related answers from the manufacturer is initiated. This exchange may require several cycles, extending time and increasing costs. The timeframe in most cases is around 18 months, but many have experienced timeframes as long as 24 months or more, and not necessarily because of complex devices.

The issue of rejected applications also fits into this context. In 2025, there are 918 rejections, which is an increase from previous years (650 in 2024). Again, it is important to read the number correctly. The increase is partly physiological, because the overall number of applications is growing, but it also reflects a rather anomalous element, namely that the main reason for rejection is not the wrong classification or qualification of the device, but the scope of the Notified Body. Most applications are rejected because they are 'outside the scope of the Notified Body'. At first glance, this might appear to be an avoidable error in the manufacturer's system for selecting the Notified Body, but in practice, the causes are often more complex. Such as, for example, simply not knowing where to look for the Notified Body's scope of designation, or, once found, the scope of designation is so hermetically defined in terms of codes, types of devices and technologies, that it is not always easy to interpret. In this context, an accurate preliminary verification of the scope, possibly supported by a direct comparison with the Notified Body at an early stage, would be a key tool to reduce the risk of rejection already at the entry stage.

If one compares the figures of 2024 with those of 2025, a consistent trend emerges. Applications increase from around 28,000 to over 31,800 (+13.8%), written agreements from around 19,000 to over 21,400 (+12.5%) and total certificates from around 15,300 to over 17,500 (+14.7%). On the other hand, waste increased from about 650 to 918 (+41.2%), with the rejection rate rising from about 2.3% to 2.9%. In summary, comparing 2025 with 2024:

An analysis of the data reported in 'Study supporting the monitoring of the availability of medical devices on the EU market - Survey results of the 18th NB survey (MDR/IVDR)' shows that another cause of application rejection is incompleteness. This may include, for example, inconsistencies between intended use and clinical evidence, clinical benefits not fully aligned with claimed performance, or technical documentation that is formally present but not sufficiently complete to allow a safety assessment. In these cases, the Notified Body is either not in a position to start the certification process, or is forced to request additions already in the preliminary stages, resulting in a longer timeframe. It follows that the quality of the initial preparation not only affects the final outcome of the certification, but also the very possibility of entering the process.

In conclusion, as the proverb suggests, 'well begun is half done': the difference is no longer determined by documentary compliance alone, but by the overall quality of the submission, understood as consistency, completeness and the ability to make the dossier truly assessable.

[1] Austrian National Public Health Institute, Areté, Civic Consulting (2026). PowerPoint presentation containing a study overview and survey results of the 18th NB survey for the ʻStudy supporting the monitoring of availability of medical devices on the EU marketʼ. Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG). Commissioned by the European Commission within the EU4Health Programme (under specific contract No 2021 P3 03 with the European Health and Digital Executive Agency, implementing framework contract No SANTE/2021/OP/0002).

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