Europe’s medical device regulations are fuelling a quiet crisis in patient care, as mounting bureaucratic delays push products off the EU market and force patients to wait years for treatments available elsewhere.
The warning – from patients, academics and industry – is gaining new urgency as Brussels moves to revise its Medical Devices Regulation and In Vitro Diagnostics Regulation, frameworks widely criticised for creating approval bottlenecks that have accelerated rather than protected against harm.
The European Commission’s reform proposals have won cautious backing from lawmakers, but stakeholders are drawing a sharp distinction between streamlining and weakening. Memi Tsekoura, president of the Greek Patients’ Association, put the tension plainly: a device that clears every safety hurdle but takes years to reach the clinic ultimately helps nobody, while one rushed to market on thin evidence can cost lives.
The political challenge for Brussels is to reconcile two imperatives that are, in principle, inseparable — rigour and speed — at a moment when trust in regulators is fragile, and the cost of getting it wrong falls, as ever, on patients.
Bottlenecks and obstacles
Delays in access are a key concern for patients and industry. “When certification processes are delayed, or regulatory pathways become unpredictable, access to important innovations is postponed,” Tsekoura said, noting that products may disappear from the market because companies cannot meet the regulatory burden.
Thanassis Akalestos, director general of the Association of Health-Research and Biotechnology Industry (SEIV), also noted that structural shortcomings affect patients, through delayed availability of technologies and disparities in access across EU countries.
Akalestos highlighted the core direction of the Commission’s proposal on simplification, innovation pathways, and international cooperation measures. Even though “not perfect”, “if preserved and reinforced, [it] will make a tangible difference for patients and industry alike,” he remarked, adding that “structural shortcomings in the regulatory system, such as duplicative, overly complex and costly processes, and inconsistent interpretation across member states” are targeted.
Tsekoura also addressed current regulatory bottlenecks, warning that they risk increasing inequalities across Europe.
“Delays in conformity assessment, inconsistent approaches between notified bodies, and slow reimbursement or HTA processes can all lead to unequal access,” she said, noting that “innovative devices often reach larger markets first, while patients in smaller or less-resourced countries may wait years.
“From a patient perspective, this is not acceptable. Access to safe and effective care should not depend on where a person lives.”
For the industry, diverging practices in conformity assessment timelines and a lack of full visibility over the cost of such procedures have led to an unpredictable certification system and severely complicated planning for manufacturers.
“Companies need to know how to plan their resources and how long they need until they can get certified and deliver medical technologies to health systems,” Akalestos explained to Euractiv, adding that predictable certification timelines and fees directly support timely patient access and continuity of supply.
As he pointed out, they also underpin responsible investment decisions, especially for SMEs that depend on regulatory stability to plan growth, secure funding, and allocate resources.
Real-world outcomes
For patients, clinical and performance evidence must reflect quality of life and usability.
“A device is not judged solely by its technical or clinical performance. What truly matters is whether it makes everyday life easier, is practical to use, supports adherence, and delivers better long-term outcomes in real-world settings,” Tsekoura said, noting that evidence generation must become more patient-centred and patients should be seen as partners rather than end-users.
As Tsekoura noted, EU4MEDTECH, a Horizon Europe project on the evaluation and regulation of high-risk medical devices (MDs) and in vitro diagnostic medical devices (IVDs), aims to ensure that patient perspectives are included from early development through to post-market evaluation.
As Prof. Ana Marušić, coordinator of the project, told Euractiv, the biggest gap under MDR/IVDR is “between the type of clinical evidence that is often expected and what is realistically feasible to generate for innovative, especially AI-based, devices.”
While robust comparative trials are preferred, that is not always feasible. “What we consistently see is that evidence for these devices is generated across the whole life cycle, combining smaller pre-market studies with real-world data, registries, post-market follow-up, and ongoing performance monitoring,” she explained.
However, MDR/IVDR still lacks clear, harmonised guidance on how to build and assess this broader evidence base, especially for AI and software devices. “That creates uncertainty for manufacturers and variability in how requirements are applied,” Marušić explained, noting that it is not about lowering standards, but better aligning evidence requirements with how these technologies are actually developed and used.
Pushing innovation out
Companies also call for more fit-for-purpose innovation pathways, ensuring that AI Act requirements are reflected in the IVD and MD regulatory system in a time-bound manner, and avoiding unintended red tape for IVD performance studies.
“We urge a fundamental rethink of the approach to reprocessing of single-use devices, where the proposed ‘reusable by default’ presumption adds unclear administrative burden and departs from established safety principles, Akalestos remarked.
Unpredictability and complexity of the system are key challenges SMEs face under the current MDR/IVDR. “For SMEs, the start of their journey is a critical step, and most of the ‘bottlenecks’ occur during the initial phase, when, due to regulatory compliance uncertainty, their investors turn away,” he explained.
“SMEs require targeted support, particularly at the early stages of development, given their limited resources compared to larger manufacturers for navigating complex regulatory requirements.”
The cost of delay in simplifying the regulatory system is cumulative. “Every month without simplification is a month in which manufacturers continue to redirect investment away from Europe, patients face avoidable disruptions to the technologies they depend on, and the EU falls further behind competing jurisdictions as a destination for regulatory approvals,” he said, adding that this is already happening, and accelerating the longer the process takes.
There is a growing, already tangible risk that SMEs are shifting their innovation outside Europe because complying with MDR/IVDR is no longer economically viable.
“Some SMEs report that up to 30% of their niche or innovative products may disappear from the market, not due to safety concerns but due to regulatory burden. These products, while clinically valuable, often generate limited revenue, sometimes only around 10% of total turnover, making the cost–benefit balance increasingly unsustainable,” he remarked.
Patient expectations
For Tsekoura, the revision should aim for a better balance between strong protection, speed, predictability, and coordination across Europe. It should therefore focus “not only on safety and innovation, but also on fairness and equal access,” she said, underlining the need for stronger regulatory capacity, less duplication, better alignment of evidence requirements, and more effective use of digital tools.
EU4MEDTECH work can help reduce fragmentation, increase predictability across the EU, and contribute to more equitable access to advanced medical technologies, helping to address existing healthcare inequalities, Tsekoura added.
Marušić explained that a more efficient and proportionate regulatory framework would need to be clearer about what evidence is needed, at which stage, and adjusting expectations depending on the device’s risk, novelty, and intended use. For many high-risk and innovative devices, evidence is built over time, combining pre-market studies with post-market follow-up, real-world data, and ongoing performance monitoring.
“EU4MEDTECH is aiming to make this approach more structured and easier to apply in practice, by developing more standardised ways of planning and assessing evidence across the lifecycle,” she noted. The programme’s framework aims to better connect regulatory and HTA perspectives, “recognising that evidence requirements do not stop at conformity assessment.”
[BM]
Source:
www.euractiv.com