IVDR Report Updates 2025

IVDR Update: JUNE2025

Analysis of Feedback Given to EU on IVDR

Background
The EU Commission ran a public consultation exercise on the Medical Devices Regulation (MDR, (EU)2017/745) and the In Vitro Devices Regulation (IVDR, (EU)2017/746). Evaluation of the 2 regulations ran from 12th December 2024 to 21st March 2025.During this time, the Commission received 584 responses, 175 of which were related to IVDR (responses searched using the keyword “IVDR”).
Baseline data relating to demographics of respondents were extracted using word counting from the relevant form fields, however in view of the complexity of the free-text responses about the regulation, we used AI to perform quantitative analysis of the responses according to six separate themes derived from manual review of all the IVDR-related submissions. These were:

1. Regulatory Burden
   Multiple respondents emphasized the excessive complexity and costs of compliance with the IVDR. This is particularly challenging for small and medium-sized enterprises (SMEs), hindering their ability to bring innovative medical technologies to market.
2. Commercial Concerns
   Concerns were raised about the costs of compliance, especially for companies who previously self-certified under the In Vitro Devices Directive and were, therefore, having to engage expensive consultancy because of their lack of familiarity with the certification process.
3. Impact on Laboratory-Developed Tests (LDTs)
   Concerns were raised about the IVDR's effect on laboratories' ability to develop and use LDTs. This includes the challenges of meeting regulatory requirements, costs, and fear of losing in-house testing capabilities.
4. Stifling Innovation
   The regulations are perceived to stifle innovation, particularly for SMEs and startups. Respondents argued that regulatory complexity discourages investment and delays the entry of new technologies into the EU market.
5. Clinical Trials and Market Competitiveness
   Some feedback pointed out the impact IVDR could have on clinical trials for new drugs, causing delays and increasing costs. This, in turn, would affect the EU's attractiveness as a market for innovative products.
6. Governance and Practical Implementation Issues
   Issues with consistency both of governance and the practical implementation of the regulations were mentioned, highlighting a need for better alignment and understanding across member states.

Results
Fig.1-3 show the proportions of the responses by country, user type and organisation size, respectively.

AI-based analysis mapped the numbers of responses to the areas given above with counts by particular sub-themes. These are given in Table 1.Categorisation across the main themes clearly produced overlapping response e.g. a major concern was that the burden imposed by regulation could affect many areas of IVD use including clinical trials, LDTs, commercialisation of existing devices and innovation/launch of new devices.

Conclusions
The Commission received hundreds of responses in its request for feedback about MDR and IVDR. An analysis of 175 of these responses relating to IVDR showed that respondents came from both across the EU and outside it, the latter presumably reflecting the concerns of those in non-EU countries trying to sell IVDs into the Union. A range of stakeholders were represented, from academic institutions and hospitals to commercial companies to individual citizens. The size of the stakeholder organizations was spread across a wide range, from individuals to large organizations/companies with up to several thousand employees.
Most respondents were highly critical of IVDR, many expressing concerns about the effect of the regulation on the availability to EU citizens of crucial medical tests, its adverse effects on clinical trials run in the Union and on innovation. In addition to this, many responses highlighted the costs and difficulty of regulatory compliance especially for small companies and non-commercial organizations such as hospitals and academic centres. Some questioned the need for there to be a new regulation at all opining that existing regulations such as ISO15189 were sufficient for laboratories. While some respondents agreed with the aim of the regulation, that of improving patient safety, many felt that this was compromised by issues with the regulation itself, the costs of compliance and problems with implementation such as the small number of Notified Bodies and lack of EUDAMED modules.

The Commission asked people what it thought of IVDR and received a “torrent of criticism” (Medtech Insight, EU Medical Device Regulations Face Torrent of Criticism In Public Consultation ) with comments like: “The IVDR is a single disaster…. Instead of improving patient care as originally requested by EU law, the exact opposite conclusion has been reached”. It will be interesting to see how it responds and what, if any, changes will be made to the regulations in the light of so many adverse comments.

IVDR Update: APRIL2025

Still not enough Notified Bodies
Spain got its first Notified Body (NB) in February when the Centro Nacional de Certificatión de Productos Sanitarios (CNCps) received its designation. The Irish NB The National Standards Authority of Ireland (NSAI) had its designation temporarily suspended in December 2024 but was reinstated on 18 March 2025 after process improvements identified in an audit were put in place. There are, therefore, currently 14 NB listed as active and able to take on certification work. There is likely still not enough NB to provide conformity assessment to all devices that require it, especially given the time taken for the process. Estimates of the time taken for certification vary: one survey found that 75% of devices received certification in 13-18 months with 17% taking 19-24 months with the chief limitations being the tightened regulatory requirements and limited time and capacity of notified bodies. These problems are exacerbated by the fact that many manufacturers may be interacting with a NB for the first time and are unfamiliar with several of the processes involved. Also, in order to maintain impartiality, NB are not allowed to act as consultants to clients for whom they are undertaking conformity assessments – they can’t “coach” a client through the process.
NB may refuse or return applications and the most common reasons are: outside of the scope of the NB, wrong classification of the device, wrong conformity assessment procedure or incomplete application.
The structure and quality of the technical documentation supporting the application can also be problematic, again made worse by an applicant’s unfamiliarity with the process and the documentation required. Here, the role of consultancies with expertise in the field, but not acting as NB, may be vital to help manufacturers get the certification they need for their products but will likely add considerably to the costs and possibly be in short supply.
Certification costs vary considerably among NB with flat fees for application of the order of several thousand € and separate fees for certification audits and assessment of technical documentation running several hundred € per hour or several thousand € per day depending on the NB. Overall, certification costs could be a minimum of €50k with the potential to go much higher, an even higher if consultancy is required. The EU mandates that all NB publish their fees for the sake of transparency and this information is available HERE
So, a lot of the issues with NB are still present and it remains to be seen how many low margin products become economically unsustainable because of regulatory costs and are, therefore, pulled from the market.

EUDAMED – the plot thickens…or does it?
So far just 3 out of 6 EUDAMED modules are operational and that only on a voluntary basis. These are:
- Actor Registration: Information on manufacturers, importers, distributors, and other relevant parties.
- UDI/Device Registration: Details on unique device identifiers (UDIs), device classification, and registration.
- Notified Bodies and Certificates: Information about notified bodies and the certificates they issue.
The other 3 modules are:
- Vigilance: Reporting of adverse incidents and recalls.
- Market Surveillance: Oversight of medical devices on the market.
- Clinical Investigations and Performance Studies: Data on clinical trials and performance studies.

It is anticipated that use of the first 3 modules, and of the market surveillance module, will become mandatory some time in 2026 with the timeline for use of the remaining 2 modules uncertain but possibly late 2026 or 2027.

In addition to huge delays – EUDAMED was intended to be operational in 2021 – there have been allegations, somewhat contentious, that the costs related to development of the databases and systems have spiralled, that the project is over time, over budget and over staffed. Whether these allegations are unfounded or not, there are still many uncertainties over how, and on what timescale, EUDAMED will become fully operational.

Be careful what you ask for…
The EU Commission called for feedback on both the MDR and IVDR with a consultation period extending from 12th December 2024 to 21st March 2025 and adoption of “fine tuning” of the regulations due in Q4 2025.There are currently 398 responses and, according to Medtech Insight, the Commission has faced a “torrent of criticism” of the regulations. Recurrent themes in the feedback include the complexity of the regulations, the difficulty and cost of their implementation (see comments about consultancy, above) and their potential to stifle innovation.
Once the consultation is closed, we’ll analyse the feedback in terms of the problems labs are having with implementing the regulations for laboratory developed tests (LDT, also called the in-house exemption, Article 5.5 IVDR) and present this as a special review.

Discontinuation of supply
In December, the EU provided guidance on “The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Medical Devices”. As of 10th January 2025, manufacturers will have to inform the EU if they anticipate an interruption in the supply of a device or intend to discontinue it in the EU if the non-availability of the device carries a risk of serious harm to patients or public health in one or more member states of the EU. Completed notifications will have to be cascaded down through economic operators e.g. distributors to final customers. Notification must be provided at least six months prior to anticipated interruption or intended discontinuation.
Included in the guidance as the phrase “It should be noted that serious harm can also be due to the inability of a healthcare professional to deliver a specific medical treatment due to an interruption or discontinuation in the supply of a device.” (our emphasis).This may have special relevance in the case of companion diagnostics where the non-availability of a specific test may interfere with the use of the therapy which is gatekeepered by the companion diagnostic.
However, the regulation does not apply to “custom-made devices”. While not clear, this, and application of the regulation to manufacturers, suggests that labs who make LDTs covered by the in-house exemption may not have to comply with the notification requirements.

So, problems remain with NBs, EUDAMED is still problematic and well behind schedule and a lot of very unhappy people have told the EU what they think of the regulation.

Watch this space…