IVDR - 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 devices sector: 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 agreementsssigned'. Applications 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includes both dossiers that have led to certification and those still under evaluation, but also those rejected, withdrawn by the manufacturer or submitted for amendments to existing certificates.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 ask at this point how mature the applications are when they enter. Looking at the 2025 data, the issue of submission maturity clearly emerges. Against 3,531 IVDR applications submitted, 1,728 written agreements were signed, while 111 applications were rejected. It follows that a numerically significant share of submissions, amounting to about 1,800 files, does not reach the contractual stage. It follows that a numerically significant proportion of submissions do not pass the preliminary screening stage and do not even reach the contractual stage. Therefore, a significant part of the submissions is still analysed by Notified Bodies without being translated into certification activity.

In an IVDR context, characterised by a smaller number of Notified Bodies and more stringent requirements, this aspect may have an even greater impact on the use of available resources by Notified Bodies.

In relation to the numbers of certificates issued (total certificates stand at around 2,194), we have no elements to fully interpret the figure, i.e. whether there are delays in assessment or requests for integration, but we can certainly say that the figure highlights the presence of a second level of complexity, linked to the timing and capacity of the system to process requests.

Looking 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. An analysis of the reasons for rejections of IVDR applications shows that the most relevant category is represented by reasons classified as 'other'. Contrary to what one might think, these are not necessarily technical causes, but often reflect operational difficulties along the certification process. The data from the October 2025 survey make it clear that this category includes, for example, situations in which the manufacturer is unable to complete the conformity assessment process or cases in which the client breaks off communication with the Notified Body. This figure suggests that a significant proportion of applications are interrupted due to organisational, strategic or regulatory pathway sustainability constraints. The more 'classic' causes, such as submission incompleteness, or incorrect qualification/classification of the device remain present but with a lower relative weight.

Overall, this seems to reflect a still evolving phase of the IVDR system, in which many companies are progressively adapting to the new requirements, with a direct impact on the continuity and maturity of submissions.

We cannot fail to examine the data related to Class D devices. These represent the highest risk category and, consequently, the one subject to the most stringent requirements. The survey data show that the number of applications for class D devices is 1,097, against 630 certificates issued, confirming both the importance of the category and the complexity of the related evaluation process. This is consistent with the fact that, for such devices, the certification process is not limited to assessment by the Notified Body, but may also involve European Union reference laboratories (EURL) and, in some cases, competent authorities, introducing further levels of review. As a result, even with fewer submissions, Class D devices contribute significantly to the overall system load, amplifying the time and complexity of the process. In this context, the quality and completeness of the initial documentation assume an even more critical role, as any shortcomings can result in particularly onerous and prolonged review cycles.

If one compares the figures of 2024 with those of 2025, a consistent trend emerges. Applications increase from around 2,600 to over 3,500 (+35-40%), while total certificates grow from around 1,700 to over 2,100 (+25-30%). Waste shows a particularly marked increase, rising from very small values in the order of a few units in 2024 to 111 in 2025, with a very high percentage increase and a rejection rate rising from about 0.4% to over 3%.

Overall, it is clear that the IVDR system in 2025 still appears to be in an adaptation phase, characterised by a lack of submission maturity.

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 coherence, completeness and 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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