The global in vitro diagnostic (IVD) market is experiencing rapid growth, fuelled by technological advances and rising demands. Valued at $108.3 billion in 2024, the IVD market is projected to expand at a compound annual growth rate (CAGR) of 5.62% through to 2030. This reflects the increasing role of IVDs in the healthcare sector, transforming diagnostic processes, enhancing monitoring, and ultimately improving patient outcomes.
A major driver of this evolution is the integration of artificial intelligence (AI) and machine learning (ML) into diagnostic workflows. These technologies are streamlining data analysis, enabling predictive modelling, and facilitating workflow automation. As a result, diagnostic processes are accelerated, accuracy is improved, and the capabilities of IVDs are expanded, providing more comprehensive insights into patient health.
This innovation is also leading to a shift toward patient-centric healthcare, including personalised medicine and point-of-care (PoC) testing. By tailoring diagnostics to individual patient profiles, IVDs support more targeted treatment strategies. PoC testing, in particular, is making diagnostics more accessible, enabling rapid results in diverse settings, from clinics to patients’ homes, improving responsiveness and overall care quality.
However, as the technology advances, so does the complexity of ensuring safety, effectiveness, and compliance. In the EU, the In Vitro Diagnostic Regulation (IVDR) now defines a far more rigorous framework for bringing IVDs to market and maintaining their compliance throughout their lifecycle.
Key Challenges in Meeting IVDR Requirements
Navigating the IVDR framework is complex, and manufacturers must navigate several challenges to maintain a CE-mark, including:
1. Aligning with Performance Evaluation Requirements
Under the IVDR, manufacturers must demonstrate that their devices meet the General Safety and Performance Requirements (GSPRs) outlined in Annex I. These requirements ensure that IVDs are safe, effective and fit for their intended purpose. To demonstrate conformance to the GSPRS, a Performance Evaluation must be conducted in line with Article 56 and Annex XIII Part A. For many manufacturers, this is a new and challenging process, as it demands both a detailed understanding of regulatory expectations and the ability to provide strong scientific evidence.
The Performance Evaluation consists of three core reports:
- Scientific Validity Report (SVR): Establishes the scientific rationale connecting the analyte to a clinical condition or physiological state.
- Analytical Performance Report (APR): Demonstrates the device’s ability to detect or measure the analyte accurately and reliably under various conditions.
- Clinical Performance Report (CPR): Shows how the device’s results correlate with clinical conditions in real-world use.
These elements are combined into a Performance Evaluation Report (PER), which must justify the device’s intended purpose, benefits, and safety.
2. Tackling the transition from IVDD to IVDR
Manufacturers of legacy devices face significant challenges in transitioning from the In Vitro Diagnostic Directive (IVDD) to the IVDR. Driven by the need for enhanced patient safety, improved traceability, and more rigorous conformity assessments, this shift requires stakeholders to navigate complex regulatory changes within a structured yet demanding timeline.
As a result of this transition, many IVDs that were previously self-certified under the IVDD now require involvement from a Notified Body, significantly increasing regulatory complexity and costs for manufacturers. From approximately 80-90% of IVDs being able to self-certify, the introduction of the IVDR means around 70-90% of IVDs now require Notified Body submission. This shift is primarily due to the IVDR’s new risk-based classification system, which imposes stricter regulatory controls on higher-risk devices, ensuring that those with a greater potential impact on public health undergo a thorough conformity assessment process. For high-risk Class D devices, the evidence requirements are especially demanding, often necessitating extensive clinical trials and real-world data.
As a result, companies are strategically optimising their product portfolios to manage rising expenses and meet stringent compliance deadlines. According to the 2024 MedTech Europe IVDR and MDR Survey, the IVD sector has reported a substantial increase in the cost of Performance Evaluation, with expenses rising by 49% or more. This surge underscores the financial and operational challenges faced by manufacturers as they navigate the more rigorous clinical evidence requirements and heightened scrutiny under the IVDR.
3. Limited Notified Body Capacity
A bottleneck in IVDR implementation has been the limited number of designated Notified Bodies (NBs). As of February 2025, only 14 NBs are designated under the IVDR compared to 37 for the MDR. Therefore, the increasing demand for conformity assessments has far exceeded capacity, leading to long timeframes for technical file review and significant backlogs. In addition, the IVDR demands more extensive documentation, performance data, and post-market plans, which lengthens the review process for each product.
This delay poses significant commercial and strategic risks:
- Missed transitional deadlines can lead to devices being pulled from the EU market until compliance is achieved.
- Disrupted product launches, particularly for innovative devices that need timely market entry to remain competitive.
- Escalating costs driven by extended NB review timelines, delayed market entry, and the need to fast-track testing to meet new requirements.
Strategies for Achieving IVDR Compliance
Meeting the IVDR’s increasingly stringent requirements requires more than regulatory awareness; it calls for a proactive, structured, and strategic approach. The following strategies can help manufacturers not only achieve IVDR compliance but also gain a competitive edge. Manufacturers should:
Perform a Comprehensive Gap Analysis
The first step toward IVDR compliance, whether as a new submission or transitioning from the IVDD, is to conduct a comprehensive gap analysis. This process maps your current state against the regulation’s full set of requirements, enabling a structured diagnostic of your technical documentation, performance data, and supporting processes. The outcome is a clear view of compliance gaps that can guide both immediate remediation and long-term strategic planning.
Conducting this assessment early provides a critical advantage: it prevents last-minute scrambling, allows for phased and prioritised actions, and ensures you can develop a complete, well-resourced compliance roadmap.
A robust gap assessment should cover:
- Technical documentation – Assess completeness and consistency against IVDR requirements.
- Performance evaluation and clinical evidence – Verify that analytical and clinical performance data meet the expanded IVDR thresholds, with a clear link to intended use.
- Post-market surveillance (PMS) and vigilance systems – Evaluate the strength of data collection, trend analysis, and reporting mechanisms to ensure they can deliver continuous compliance.
- Labelling, IFUs, and risk management files – Confirm that risk-benefit analyses, hazard identification, and user information are aligned with IVDR language, format, and content expectations.
When executed strategically, manufacturers build a compliance roadmap that not only addresses current deficiencies but also strengthens operational resilience, accelerates NB review readiness, and supports future product innovation under the IVDR framework.
Engage with Notified Bodies Early
Limited NB capacity, longer review cycles, and increased evidence requirements mean that waiting until your technical file is “finished” can lead to missed deadlines or prolonged market entry delays. Instead, manufacturers should initiate discussions with their chosen NB as early as the design and development stage, well before formal submission.
Strategic benefits of early engagement include:
- Securing assessment slots far in advance of key regulatory deadlines, reducing the risk of being caught in capacity bottlenecks.
- Aligning evidence generation with NB expectations, which minimises the risk of costly nonconformities or repeated rounds of review.
- Identifying potential classification or scope issues early, preventing late-stage surprises in risk categorisation that could derail timelines.
- Clarifying interpretation of evolving guidance, helping ensure that your approach to clinical evidence, performance evaluation, and post-market surveillance matches current regulatory expectations.
Treat your NB as a collaborative partner. Building a relationship and engaging with a NB early creates an ongoing dialogue, enabling manufacturers to integrate feedback into their quality and development systems. This turns the NB review from a one-off hurdle into a continuous alignment process, shortening approval times, improving documentation quality, and safeguarding market access.
Invest in Robust Clinical and Performance Data
Under the IVDR, performance evaluation is central to conformity assessment and must be supported by a comprehensive Performance Evaluation Report (PER) as defined in Annex XIII. This represents a major step up from IVDD requirements, shifting from limited pre-market data to a scientifically rigorous, ongoing evidence-generation process. Manufacturers are now expected to provide robust clinical evidence that not only demonstrates compliance with the General Safety and Performance Requirements (GSPRs) but also verifies performance, safety, and scientific validity throughout the device’s entire lifecycle.
Manufacturers should aim to:
- Conduct comprehensive analytical performance studies to verify parameters such as accuracy, precision, sensitivity, specificity, repeatability, reproducibility, and limits of detection, aligned with the intended purpose stated in the technical documentation.
- Undertake clinical performance studies (where required under Annex XIII Part A, 2.3) or justify equivalence to existing data, demonstrating that the device’s performance translates into clinically relevant outcomes.
- Maintain a Scientific Validity Report (SVR) to ensure a systematic, referenced summary of the clinical association between the analyte and the targeted clinical condition, based on peer-reviewed literature, authoritative guidance, or consensus documents.
- Ensure documentation meets “state-of-the-art” standards as interpreted under IVDR Article 2(54), with processes in place for continuous literature monitoring and updates to the PER when new evidence becomes available.
High-quality, well-maintained performance evidence reduces the risk of nonconformities during Notified Body review, supports faster approvals, and enhances market credibility. Beyond compliance, it provides a scientifically robust foundation for marketing claims and clinical adoption, transforming regulatory data into a commercial asset.
Strengthen Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
The IVDR embeds lifecycle regulatory control, meaning obligations extend well beyond CE marking. PMS requirements are detailed in Articles 78–81 and must be proportionate to the device’s risk class, ensuring that safety, performance, and scientific validity remain continuously verified.
Key tools and obligations include:
- PMPF Plans and Reports (Annex XIII, Part B) – Ongoing studies, registries, or data collection designed to confirm continued performance in the intended population.
- Integration of real-world evidence – Leveraging registries, observational studies, customer feedback, complaint handling systems, and literature reviews.
- Periodic Safety Update Reports (PSURs) – Mandatory for Class C and D devices (Article 81), summarising post-market findings, sales volumes, usage populations, and corrective actions taken.
- Trend reporting – As required by Article 82, for identifying statistically significant increases in non-serious incidents or expected side effects.
When PMS and PMPF are treated as more than compliance exercises, they become strategic intelligence systems. The data generated can identify market trends, highlight competitive advantages, and drive next-generation product design. Manufacturers with mature PMS frameworks are also better positioned for faster NB re-certifications and for entering new markets where post-market data is increasingly demanded by regulators and payers.
When Compliance becomes a Competitive Advantage
The introduction of the IVDR is one of the most significant regulatory shifts in the history of EU diagnostics. While it presents undeniable financial, operational, and logistical challenges, it also provides a framework that prioritises patient safety, transparency, and innovation.
Manufacturers that embrace early compliance, integrate robust data systems, and invest in post-market monitoring will not only safeguard EU market access but also gain a competitive edge in a rapidly evolving global diagnostics market. By aligning innovation with regulatory excellence, companies can ensure their IVDs remain at the forefront of healthcare, delivering accurate, timely, and impactful insights that improve patient outcomes.
To navigate the complexities of the IVDR and turn regulatory compliance into a competitive advantage, Mantra Systems offers specialised consultancy services for IVD manufacturers. By combining deep regulatory expertise with practical, actionable strategies, Mantra Systems helps companies efficiently manage performance evaluations, Notified Body interactions, and post-market obligations, ensuring timely EU market access while minimising risks and operational burdens.
