
Perhaps the most important announcement for this update is that the EU Commission have, finally, announced a date for partial implementation of the devices database EUDAMED. Following the announcement on 25th November 2025, use of the first 4 modules of EUDAMED will become mandatory on 28th May 2026.These modules are:

Actor registration
Enables registration of economic operators and provides Actor ID/Single registration number (SRN) 

Actor registration module - Public Health - European Commission

UDI/Devices registration
Enables registration of unique device identifiers (UDI) 

UDI/Device registration - Public Health - European Commission

Notified Bodies & Certificates
Gives data provided by Notified Bodies (NB) on certificates of conformity 

Notified Bodies and Certificates module - Public Health

Market Surveillance
Primarily aimed at providing information from Competent Authorities (CA) 

Revision of the Regulations and Call for Feedback


The EU Commission published an amending act for MDR and IVDR in recognition of the problems with the regulations, putting forward a large number of amendments. The document itself is an eye-watering 170 pages but there’s a good summary from B.S. Partnership here: 

EU MDR & IVDR Amendment 2025: Key Changes for Manufacturers — BS Partnership


The EU Commission then sought feedback on the proposed changes with an initiative entitled: “Targeted revision of the EU rules for medical devices and in vitro diagnostics” (see 

Medical devices and in vitro diagnostics – targeted revision of EU rules

 for full details).
The Commission recognised the “challenges” associated with implementation both of MDR and IVDR and has faced numerous requests from the EU parliament, individual member states and various stakeholders to simplify the regulatory framework.It acknowledged that the overly onerous regulatory environment imposed by the regulations could potentially lead to the withdrawal of devices from the EU possibly affecting patient health and could also reduce the competitiveness of the EU as a marketplace for medical devices and IVDs, disproportionately affecting SMEs.Therefore, the Commission initiated a targeted revision strategy which aims: “to simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate, while preserving a high level of public health and patient safety and maintaining the overall structure of the current regulatory framework”.It then ran a consultation exercise to collect feedback from stakeholders, although not the public, about proposed revisions directed particularly towards SMEs.


The aims of the proposed revisions, given in the amendments act and call for evidence were:

reduce the administrative burden including reporting obligations;

enhance the predictability and cost-efficiency of the certification processes of notified bodies;

make the conformity assessment requirements more proportionate, especially for low- and medium- risk devices and those that cater to special patient needs;

streamline procedures including those on governance;

enable the EU medical device sector to benefit from international cooperation including reliance, where appropriate;

better align the regulatory framework with other relevant legislation.

The consultation ran from 8th September 2025 – 6th October 2025 and the results are now published on Europa (

).
There were 441 responses received with nearly a quarter from Germany alone and approximately 62% from businesses or business associations. Of the 441, 173 were specifically focused on IVDR (i.e. filtered out using “IVDR” as the keyword).
No breakdown of the data specific to IVDR was given and Diaceutics will, therefore, publish a breakdown and sentiment analysis of IVDR-specific responses early in the New Year.


There are now 19 NB with a third one in Finland added since the last report. While capacity may be becoming less of an issue, there are still concerns that the certification process represents a significant bottleneck according to MedTech Europe with extended timelines, increased costs and uncertainty surrounding them, and lack of clarity around clinical evidence and documentation requirements all contributing.Additionally, just what “capacity” actually means in terms of ability of NB to certify devices may need better definition (Section 4).
Certification times ranging from 6-24 months with an average of 18 months mean that many companies are trying to get their devices registered in other jurisdictions first, or in parallel with the EU in order to bring their products to market sooner.
Again, these bottlenecks may disproportionately affect SMEs who likely have less experience navigating the regulatory landscape than do larger companies and also are less able to mitigate the effects of delays and increased costs.



Monitoring of Availability of Medical Devices on the EU Market


The Commission published the results of Monitoring of availability of medical devices on the EU Market - Study overview and 2nd survey results on 1st December 2025.Study data were gathered up to October 31st, 2024, and covered a number of aspects relating to the availability both of medical devices and IVDs. The full publication is available at: 


The study was performed using surveys and mainly focuses on medical devices; only about 16% of survey responses were about IVDs.
67% of the companies responding were medium, small or micro size (i.e. employing less than 250).
Up to 31st October 2024, there have been 1246 applications for IVD certification lodged with NBs of which 423 (34%) had had certificates issued.
In addition to the 823 outstanding applications, there are another 5362 applications for IVD previously regulated under IVDD and which are expected to be transitioned to IVDR.42% of manufacturers indicated that <50% of their products intended to be regulated under IVDR had been transferred. Around 20% of manufacturers said that they had less than 10% of their products transferred although this figure is down from the previous survey. On the plus side, 30% of manufacturers reported that they had 90%-100% of their products transferred to IVDR.
Regarding NBs, the survey results suggested that a number of manufacturers (37%) are still not engaging with NB to get their products regulated with the majority of those citing financial reasons and lack of clarity in the regulation for not proceeding. With 19 NB now operating, reasons other than NB capacity may be causing bottlenecks (Section 3), and those companies not engaging with NB may run into difficulties as the deadline for full compliance approaches. In this context, it’s interesting to note that the main reason for refusal of application cited by NB is “Insufficient notified body resources” suggesting that even once a company finds and engages with a NB, there may still be issues even if the application itself has no problems. Therefore, the issue of NB capacity may not be one of actual 

 capacity.
Despite this, numbers of certificates of conformity under IVDR are increasing, up to 423 covering 5419 devices (as catalogue numbers) as of 31st October 2024.Of these, 43% are Class C which covers companion diagnostics.
Time taken to prepare an application before submission to an NB was 6-12 months for most manufacturers although around a quarter of companies reported a preparation time of >19 months and a quarter reported <6 months, presumably a reflection of the familiarity of the manufacturer with the regulation and the requirements for their IVDs. Of concern is that Class C is over-represented in the groups with longer application preparation times. After submission, the most common time for certification is 13-18 months. Again, this may become an issue as the deadline for certification of legacy devices (i.e. those previously regulated under IVDD) approaches.
Another concern, repeatedly stated by stakeholders, is the regulatory burden imposed by IVDR compliance may lead to the withdrawal of some IVDs from the EU market. This has been recognised by the Commission (Section 2), perhaps as a result of the survey which reported that 40% of manufacturers had stopped supply of some IVDs into the EU market since 2022, and 37% planning to discontinue some IVDs. Of the different reasons given, 64% related to costs of compliance making the products economically unviable.




There is still no real clarity on implementation of IVDR in respect of LDT (also called in-house tests). Cobbaert and colleagues published an interesting opinion piece (

Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics - PubMed

) outlining some of the issues IVDR will cause to use of LDT and calling on the Commission to revise the regulation and take regard of the reasoning behind the recent US court decision to not allow the FDA to regulate LDT. Some of these changes have been put into the act amending MDR and IVDR (Section 2) but it’s clear that one of the main problems with the in-house exemption (Article 5(5)), that of LDT requiring justification for use if an identical test is placed on the market, will remain. The only concession the EU Commission gave on this was that there should be a “lengthy” transition period from a LDT to the commercially available product. The main reason labs use LDT is because they are generally cheaper than the corresponding commercially available test. The regulation would still have the effect of forcing labs to decide whether to use a more expensive test or to discontinue using their LDT. Also, as Cobbaert et al. point out, the regulation disincentivises labs to develop novel LDT if at some point a manufacturer launches a commercial version and the lab is obliged to use that instead of the test they developed. Oddly, it may also delay commercial development of novel tests if manufacturers wait to see what technology a non-commercial lab uses for a test, how it performs and what the demand is before making the decision to develop their own version.




It’s clear that progress on implementation of IVDR is being made. Long delayed, EUDAMED is now sufficiently in place for its use (at least for 4/6 modules) to become mandatory in May 2026.The Commission has recognised the “deluge of criticism” the regulation has received and is exploring ways to streamline and improve its implementation. There are now 19 NB.
However, issues remain.The availability survey suggested that functional capacity of NB may still be a problem, a number of IVD manufacturers have yet to engage with a NB while some are withdrawing products from the EU market, mainly due to economic considerations.There are still problems with the regulation around use of LDT.
The timescales for preparation of applications, review by NB and issue of certificates of conformity means that the deadlines for legacy devices (those previously regulated under IVDD) are in practical terms quite close: 2 years from now for Class D devices, 3 years for Class C and 4 years for Class B/sterile Class A.
It remains to be seen what stakeholders feel about the proposed revisions, how EUDAMED will perform under mandated (opposed to its current voluntary) load and how the problems surrounding use of LDT will play out.


Our analysis of the results of the EU targeted evaluation of IVDR and MDR, plus news reports at the time, showed that most stakeholders were very dissatisfied both with the regulation and its implementation with some questioning the necessity for the regulation in the first place.
This has been confirmed by the release of the EU’s own summary report of the responses to the evaluation (Factual Summary Report on the Public Consultation for the Targeted Evaluation of the EU Rules on Medical Devices and In Vitro Diagnostics 

eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:Ares(2025)4926888


The chart shows that only 2% of all stakeholders think the regulation has contributed to innovation in the EU and only a minority think that the regulation improves the protection of IVD users and patients. Interestingly, around 80% of stakeholders felt that the regulation did not create a level playing field for all economic operators with less than 10% agreeing that costs of compliance with the regulation were acceptable. This is borne out by the experience of IVD manufacturers (see below).
There are signs that the EU is beginning to listen to the “torrent of criticism” it has received over the regulation with the recent (08SEP2025) publication of “Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices as regards simplification and burden reduction” (

https://eur-lex.europa.eu/legal-content/AUTO/?uri=PI_COM:Ares(2025)7425764&qid=1757593574917&rid=1

). It remains to be seen what comes of this initiative.


The Commission’s phased rollout approach (enabled by Regulation (EU) 2024/1860) foresees “functionality” notices being published in the Official Journal of the EU (OJEU) for four modules first (Actors, UDI/Devices, NB & Certificates, Market Surveillance), with vigilance later. Publication, which was originally signpostedfor “around July 2025” is now generally referenced as “Q3 2025,” although no notice confirming module functionality has been published in OJEU.The EU did put a regulation into force in July 2025 enabling the gradual rollout of EUDAMED modules with a proposed timeline of Jan 2026 for mandatory use of the 4 functional modules and a timeline of Q2 2026 for mandatory use of the Vigilance module. However, the timeline is marked as “Under review, 

) so it’s advisable to keep monitoring the situation and be prepared for compliance with the implementation.


There are currently 18 NB: 4 in Germany, 2 each in the Netherlands, Finland and Italy, and one each in Austria, Belgium, France, Ireland, Norway, Poland, Slovakia and Spain. This is still likely to be insufficient to meet demand for timely certification of devices (see below) and could lead to more problems with implementation of the regulation.


Medical Device Coordination Group (MDCG) has released guidance on IVDR testing (

https://health.ec.europa.eu/latest-updates/mdcg-2025-5-questions-answers-regarding-performance-studies-vitro-diagnostic-medical-devices-under-2025-06-18_en

https://health.ec.europa.eu/latest-updates/mdcg-2025-4-guidance-safe-making-available-medical-device-software-mdsw-apps-online-platforms-june-2025-06-16_en

MedTech Europe has called for device sampling to be made more proportional to the risk classes of devices to avoid a disproportionate burden on in vitro diagnostic (IVD) manufacturers. MDCG guidance requires sampling of Class B and C devices under the IVD Regulation to be proportionate to the total number of devices under that certificate. MedTech Europe said “it is expected that 15% of technical documentation is reviewed per representative group of devices during each five years cycle which notified bodies may reduce to 5%.”Class B and C devices account for more than 90% of IVDs on the EU market, the trade group said, and as such the 15% sampling requirement “has a high burden on IVD manufacturers, especially small and medium-sized enterprises.” Average costs per one technical file assessment during an initial certification audit can total €38,000 ($43,000), according to MedTech Europe (

Sampling under In Vitro Diagnostics Regulation: MedTech Europe proposal for a more risk-based approach - MedTech Europe

Team-NB called for central governance, coordination and support for IVDR implementation. Team-NB, the European association of medtech notified bodies, published the paper with NBCG-Med, a notified body coordination group established as part of the medtech regulations. The groups framed their proposals as a response to a medical device regulatory framework that “faces fragmentation and inconsistent implementation, hindering safety, innovation and timely access.”
 
In response, the groups have proposed “a future governance model that integrates centralized support mechanisms, enhanced scientific and regulatory coordination and sustainable funding.” The plan is built around the Medical Device Coordination Office (MDCO), a proposed central coordination and support structure.
 
MDCO will oversee notified bodies, coordinate classification and qualification decisions, create guidance on how the legal system should work and develop technical and clinical guidelines. Other planned tasks for MDCO include coordinating consultation procedures, facilitating special pathways for certain devices and coordinating vigilance.
 
Notified bodies remain key players in the proposed system, with Team-NB and NBCG-Med making the case that their role as “as technical, regulatory and clinical ‘extended arm’ of the authorities should be maintained.”
 
“Moreover, notified bodies operate under strict designation and oversight criteria, ensuring independence, competence and impartiality. Their involvement in a centrally coordinated system — such as through the proposed MDCO — would enhance consistency and efficiency without compromising the decentralized strengths of the current model,” the notified body groups said.
 
The proposed model would give notified bodies advisory roles in decision-making structures. Team-NB and NBCG-Med said notified bodies could add value to expert committees, guidance development, special pathway procedures and classification discussions. The groups are also calling for NBCG-Med to get an expanded mandate to boost its contribution to guidance development and harmonization efforts.
 
Team-NB and NBCG-Med propose funding MDCO through a mix of user fees and contributions from the EU budget. Companies would pay “modest fees associated with activities in EUDAMED,” the groups said, and could pay additional fees for specific services such as early advice.

Another set of proposals covers special pathways and early advice. The notified bodies said they support the creation of a special pathway for devices that face disproportionate challenges under the medtech regulations, such as pediatric, orphan and breakthrough products.
 
“However, such pathways must not be implemented solely between manufacturers and individual notified bodies, as this could lead to inconsistencies and regulatory uncertainty. Instead, a coordinated process with clear guidance and oversight is essential,” the notified bodies said.
 
The notified bodies proposed adding a special pathways annex to the medtech regulations to define the eligibility criteria, minimum data requirements and other details. The proposals include a suggested process for seeking special pathway status. (

NB-Perspective-on-Future-Governance-in-EU-medical-device-sector-20250728.pdf

Webinar Encapsulates Manufacturers’ Problems


A recent webinar by 360DX highlighted some of the problems being faced by IVD manufacturers, particularly SMEs as they try to navigate compliance and launch devices onto the EU market.

The panel highlighted several problems with NBs:
NB aren’t allowed to consult so questions about issues with technical documentation can be very vague to avoid accusations of coaching. This leaves manufacturers trying to identify the problem with their documentation before they can begin to address it.
Manufacturers know that getting to grips with the detail of the IVDR entails a steep learning curve and this also applies to NB. One panellist in the webinar stated that “NB still need to find their feet” and this can lead to delays in review of documentation. One company switched NB after being told by their original NB that there would be a 9-month delay before examination of their submission.


The panellists had experienced challenges in terms of consistency of NBs with divergence of opinion in approach. Manufacturers don’t have access to all (e.g.) Team NB papers and may disagree with their positions.
It was agreed that the EU is still working out the process of implementation. Delays affect planning, cause hesitancy in responses from EU and may create a false sense of time for companies leading them to think they have longer to get things done than they actually have.
The panel also identified issues with guidance with one panellist describing the situation as “a lot of guidance but not enough guidance”. For context: IVDR 300 pages of regulations with the same quantity of implementation legislation. There are over 2000 pages of MDCG guidance. This makes it difficult for small QA/Reg teams to keep up with all relevant legislation giving them so much guidance it causes a bureaucratic overload and suggests the original legislation was not well written. In addition to this, most guidance relates to the MDR not IVDR, and IVDR guidance is delayed relative to MDR forcing companies to use MDR templates/guidance for IVD which are often not appropriate.


There was some debate over whether IVDR offers any actual benefits over the previous legislation, IVDD (see the section on the evaluation, above)
Some felt that it gave more confidence in safety of devices perhaps but that it may not provide more patient safety. Panellists felt that the Summary of Safety and Performance (SSP) does not provide any additional safety, so it becomes, in effect, just a bureaucratic exercise.
Some panellists thought that it could bring benefits but right now posed lots of challenges with uneven guidance and interpretation across countries. Harmonisation should be occurring but isn’t. One of the biggest problems is implementation started before all the infrastructure elements were put in place (see the section on EUDAMED, above).
Because of these difficulties, companies don’t know timeline and costs of placing a product onto the market and need improved transparency about costs and timeline.
The increased regulatory burden translates into increased costs but this is not reflected in reimbursement of test costs in many EU countries, which makes things especially difficult for SMEs.
These problems mean that many companies are choosing to launch new products in jurisdictions other than the EU, delaying access to new innovative tests which could have detrimental effects for patients. This likely underpins the evaluation finding that only 2% of respondents thought the regulation contributed to innovation in the EU (above).


Implementation of IVDR is still very much a work in progress although progress is being made, albeit at a slow pace. There are problems across the entire range of implementation activities for the regulation, and this is potentially restricting access to innovative new tests for the patients in the EU.


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:


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.


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.

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.


The regulations are perceived to stifle innovation, particularly for SMEs and start-ups. Respondents argued that regulatory complexity discourages investment and delays the entry of new technologies into the EU market.

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.

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.


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.


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.


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 


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.


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.


In December, the EU provided guidance on “The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and 

 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 gate-keepered 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.

As we approach the close of 2025, the IVDR regulatory landscape continues to take shape. Throughout the year, we’ve been sharing regular updates on the changes ahead, and this latest update brings some genuinely encouraging signs of progress worth highlighting.

Advanced molecular diagnostics are fundamentally transforming patient outcomes. Historically, diagnosis and treatment relied on the location and stage of the tumour. Now, increasingly sophisticated approaches allow healthcare professionals to understand cancer in much greater depth, enabling the selection of personalized treatments that target specific biological pathways. This detailed understanding can improve effectiveness and reduce the chance of severe side effects.

• BRCA Mutation Testing: The medical benefit of knowing BRCA status has increased steadily since its discovery 30 years ago. Professor Pujol discusses how BRCA mutations, which affect about one in 200 individuals, are vital not only for prevention but also for personalized treatments using PARP inhibitors across breast, ovarian, prostate, and pancreas cancers. ASCO guidelines now propose testing any woman with breast cancer under 65, any man with breast cancer, and every woman with ovarian cancer.

• Tissue-Agnostic Therapies and Trial Design: Progress in defining molecular alterations shows that frequent or rare alterations (like gene fusions or MSI) can be present across cancers regardless of their site of origin. This requires researchers to think beyond the primary tumour site. The podcast delves into novel clinical trial designs, such as basket trials and synthetic control arms, developed to rapidly test genetic mutation-drug matches across multiple cancer types.

• Biomarkers in Immunotherapy: We explore the role of Micro Satellite Instability (MSI) as a predictive biomarker for sensitivity to immunotherapies. While the FDA granted immune checkpoint inhibitor the first tissue agnostic approval for MSI-high/dMMR solid tumours, the pan-European (EMA) and national regulatory landscapes show variation in approval and access.

• The Power of NGS and Liquid Biopsies: Next-Generation Sequencing (NGS) is considered the standard of care for lung cancer, where over 10 alterations are targetable. NGS is widely seen as more cost-effective than sequential testing methods. Furthermore, liquid biopsies are becoming a highly promising tool for monitoring resistance, identifying minimal residual disease, and even moving towards early detection and screening.

Despite these incredible medical advances, complex regulatory and reimbursement pathways in European countries are slowing the availability of new technologies and contributing to inequalities in cancer outcomes. The discussion highlights the urgent need for policymakers to act in five key priority areas to ensure health systems are ready to adopt advanced diagnostics and achieve better testing and better treatment for all people with cancer.

Ready to learn how we can move from under-considering diagnostics to making them a priority? Download the full episode, "

Targeted therapies in cancer: From clinic to labs

" to hear the full discussion on these vital issues.

Isabelle Bedrosian et al. Germline Testing in Patients With Breast Cancer: ASCO–Society of Surgical Oncology Guideline. J Clin Oncol 42, 584-604(2024). 

Casak SJ, Marcus L, Fashoyin-Aje L, Mushti SL, Cheng J, Shen YL, Pierce WF, Her L, Goldberg KB, Theoret MR, Kluetz PG, Pazdur R, Lemery SJ. FDA Approval Summary: Pembrolizumab for the First-line Treatment of Patients with MSI-H/dMMR Advanced Unresectable or Metastatic Colorectal Carcinoma. Clin Cancer Res. 2021 Sep 1;27(17):4680-4684.

We're bringing back a must-listen episode of the Diaceutics podcast series

. Diaceutics is committed to enabling better testing and better treatment, placing labs at the centre of this mission.

In this lively discussion, we feature two leading experts: 

 (CEO of the Comprehensive Regional Cancer Institute Centre Jean PERRIN, France, and Deputy President, UNICANCER) and 

 (Head of Cancer Genetics department at the University Hospital of Montpellier, France, and President of the French Society of Predictive and Personalized Medicine). They explore the challenges and opportunities in implementing targeted therapies in cancer, specifically from a European point of view.

An oncogenic fusion is a hybrid gene formed when a portion of one gene fuses with a portion of another, often resulting from structural variants such as translocations or inversions at the DNA level. This leads to a chimeric, aberrant protein.

In lung cancer, these fusions are often the "driver mutation" of the tumour. Identifying these drivers is crucial because effective, targeted treatments exist for fusions such as ALK, ROS1, and RET. Dr. Saxena emphasises that if testing isn't performed, patients miss out on these treatments. For example, studies on ALK-targeted therapy in metastatic lung cancer showed that after five years, the median progression-free survival had not yet been reached, highlighting the amazing, life-changing responses possible if the fusion is detected.

It is standard practice to test for these fusions in virtually all patients with non-small cell lung cancer (NSCLC), particularly those with stage four or metastatic disease, or those with lung adenocarcinomas, as effective therapies are available.

The discussion highlights the diverse methodologies available for detection. While low-throughput methods like Immunohistochemistry (IHC) and Fluorescent In Situ Hybridization (FISH) are used, more comprehensive approaches are becoming standard.

• IHC is widely available and provides fast results, which can be useful for quickly informing decisions (such as what not to give, like immunotherapy in ALK-positive patients). However, IHC is generally better used as a screening tool for many fusions (except ALK) and requires confirmatory testing.

• Sequencing methods offer higher throughput. DNA-based sequencing can be challenging because fusion breakpoints often occur in large intronic regions that are difficult to cover.

• RNA sequencing is highly recommended and often utilized, as it sequences the expressed RNA transcripts after the intronic regions have been spliced out. This method demonstrates a clear benefit: a highly cited study by Reema K. Benayed et al.

, found that performing RNA sequencing detected a previously undetected driver alteration in up to approximately 14% of cases that were DNA sequencing negative.

Comprehensive panels often include both DNA and RNA sequencing simultaneously to maximize detection capability. Dr. Solomon notes that comprehensive sequencing helps detect rare and novel fusions.

The clinical relevance of testing necessitates clear and rapid communication between the lab and the treating physician. Turnaround time (TAT) is constantly being optimized as it is crucial for patient management.

To facilitate treatment decisions, reports must be clear and concise. Oncologists, like Dr. Saxena, appreciate reports that prioritize FDA-approved or known relevant mutations upfront. Both experts agreed that having descriptive blurbs that provide context and knowledge about the specific mutation (e.g., efficacy data or clinical trial status) is very useful, rather than just positive/negative listings. Pathologists often rely on vast knowledge bases (like 

) to ensure accuracy and relevance when drafting these interpretations.

Molecular pathology is rapidly changing. Although common fusions (ALK, ROS1) are well-established, newer fusions like NTRK and NRG1 are seen in very small percentages of cases (less than 1% to 2%).

 Dr. Solomon believes that increased, comprehensive RNA sequencing on more tumours will lead to the recognition of additional targetable fusions.

Ultimately, better testing enables better treatment.

Listen to the full episode of the Diaceutics 

Solomon BJ, Liu G, Felip E, Mok TSK, Soo RA, Mazieres J, Shaw AT, de Marinis F, Goto Y, Wu YL, Kim DW, Martini JF, Messina R, Paolini J, Polli A, Thomaidou D, Toffalorio F, Bauer TM. Lorlatinib Versus Crizotinib in Patients With Advanced 

-Positive Non-Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study. J Clin Oncol. 2024 Oct 10;42(29):3400-3409.

Benayed R, Offin M, Mullaney K, Sukhadia P, Rios K, Desmeules P, Ptashkin R, Won H, Chang J, Halpenny D, Schram AM, Rudin CM, Hyman DM, Arcila ME, Berger MF, Zehir A, Kris MG, Drilon A, Ladanyi M. High Yield of RNA Sequencing for Targetable Kinase Fusions in Lung Adenocarcinomas with No Mitogenic Driver Alteration Detected by DNA Sequencing and Low Tumor Mutation Burden. Clin Cancer Res. 2019 Aug 1;25(15):4712-4722.

O’Haire, S., Franchini, F., Kang, YJ. et al. Systematic review of NTRK 1/2/3 fusion prevalence pan-cancer and across solid tumours. Sci Rep 13, 4116 (2023).

Sushma Jonna; Rebecca A. Feldman; Jeffrey Swensen; Zoran Gatalica; Wolfgang M. Korn; Hossein Borghaei; Patrick C. Ma; Jorge J. Nieva; Alexander I. Spira; Ari M. Vanderwalde; Antoinette J. Wozniak; Edward S. Kim; Stephen V. Liu. Detection of NRG1 Gene Fusions in Solid Tumors. Clin Cancer Res (2019) 25 (16): 4966–4972.

We are re-promoting the insightful fifth episode of the Diaceutics "Better Testing, Better Treatment" podcast series: "

Oncogenic Fusion Detection and Reporting in NSCLC and solid tumors: from clinic to lab

In this highly important episode, we hear from 

, Assistant Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine, and 

, Assistant Professor of Medicine at Weill Cornell Medical College, as they discuss the practical considerations for oncogenic fusion detection and reporting.

The episode explores the vital connection between pathologists and oncologists, a partnership central to Diaceutics' mission of enabling better testing and better treatment. Dr. Park and Dr. Talwalkar emphasize that this collaboration is critical in the field of precision medicine. Pathologists are described as the "detectives of the medical world," unravelling disease mysteries through microscopic examination, while oncologists are the "warriors on the front lines," using those discoveries to design lifesaving treatments.

A powerful case study highlighted how their close working relationship—facilitated by quick communication via text or secure chat—changed a patient’s treatment course. When Dr. Park needed HER2 IHC 3+ testing for a patient with stage 4 bladder cancer to qualify them for an FDA-approved pan-tumour treatment, Dr. Talwalkar was able to prioritize the IHC assay, providing results in 24 to 48 hours, unlike mutation analysis which can take days or weeks.

Optimising Testing and Navigating Barriers

The experts discuss key strategies for optimising diagnostics and tissue procurement. For instance, in bladder cancer, they implemented an FGFR reflex testing protocol for newly diagnosed, eligible patients, ensuring results are automatically ordered by the pathologist signing out the case. This expedites patient care by having results available when the oncologist sees the patient.

The panel also addressed the challenges in the field, noting that insufficient tissue remains a significant barrier to optimum patient care. Historic tissue, often used for diagnosis, may have DNA that is damaged or denatured by the time new testing is required.

Looking ahead, Dr. Park and Dr. Talwalkar discuss how innovation will strengthen their relationship. They agree that the biggest change for pathologists will be the digitalization of glass slides, coupled with the deployment of AI to improve diagnosis and turnaround time. AI can already be used for tasks such as Gleason scoring and complex data analysis for immunotherapy purposes.

However, the rise of molecular diagnostics will lead to reports containing more information, such as NGS reports with 30 or 40 actionable mutations. This flood of data will necessitate even stronger communication between pathologists and oncologists to determine the true driver mutation and predict clinical benefit.

At the heart of the conversation is the understanding that communication is the key to improving patient survival and care.

The Pathology-Oncology Connection: Labs in Action

Did you miss Episode 8 of the Better Testing, Better Treatment podcast series, titled "The Pathology-Oncology Connection: Labs in Action"?

 leads a lively discussion with two critical voices in the fight against cancer: 

, a Genito urinary medical oncologist and Co-director of GU cancer clinical trials at the Norton Cancer Institute, and 

, a hematopathologist and molecular pathologist at CPA Lab, Norton Healthcare.


The Hematopathology Team: from Slide to Strategy 

In episode 9, we are joined by Dr. Philip Kuriakose and Dr. Juan Gomez-Gelvez, who analyse how collaboration within hematopathology drives optimal patient care.

Dr. Philip Kuriakose, MD is a Hematology Medical Oncologist and the Medical Director of the Hemophilia and Thrombosis Treatment Center at Henry Ford Health.

Dr. Juan Gomez-Gelvez, MD is a Hematopathologist, Molecular Pathologist and the Section Head of Molecular Hematopathology also at Henry Ford Health.

The Better Testing, Better Treatment Podcast series

We are excited to announce that our ninth episode is now available!

Insights

IVDR Report Updates 2025

Unlock the Future of Cancer Treatment: Targeted Therapies from a European Perspective

Oncogenic Fusion Detection - Bridging the Gap from Clinic to Lab

The Pathology-Oncology Connection: Labs in Action – Why This Dynamic Partnership Drives Precision Medicine

The Hematopathology Team: from Slide to Strategy