Stakeholders Weigh in on Targeted Revisions on EU Regulations on Medical Devices and In Vitro Diagnostics 

This article was exclusively written for The European Sting by two of our passionate readers, Ms. Ifza Zia and Mr Enrique De La Cruz, student researchers in public health. The opinions expressed within reflect only the writers’ views and not necessarily The European Sting’s position on the issue.

As the European Commission continues reviewing the implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), stakeholders across the healthcare and biotechnology sectors are proposing reforms aimed at improving the efficiency of the regulatory system while maintaining strong patient safety standards. The Commission has acknowledged that the transition to the new framework has created challenges for manufacturers and healthcare providers, including complex certification procedures, limited notified body capacity and delays in bringing new technologies to market. In response, the Commission has proposed targeted adjustments to ensure that the regulatory system remains robust but more predictable and accessible for innovators. 

Among the organisations contributing to this policy discussion is the U.S.-based biohealth think tank Revitalised Medicine, which has presented a series of recommendations focused on improving regulatory efficiency, supporting innovation and strengthening the competitiveness of the European medical technology sector. One of the key issues highlighted by the organisation is the disproportionate regulatory burden faced by small and medium-sized enterprises. Revitalised Medicine argues that compliance costs and administrative requirements under MDR and IVDR can place significant pressure on smaller manufacturers, limiting their ability to develop new technologies. To address this challenge, the organisation recommends introducing SME-adapted conformity assessment pathways, reduced regulatory fees and simplified documentation systems, alongside dedicated advisory support to guide smaller companies through regulatory processes. 

Another concern raised by Revitalised Medicine relates to the length of certification and recertification timelines under the current framework. Limited notified body capacity and complex documentation requirements have contributed to prolonged review processes, which can delay the introduction of safe and beneficial medical technologies to patients. The organisation proposes establishing clearly defined maximum review timelines and accelerated assessment pathways for breakthrough or high-priority medical devices. Such measures, it argues, could reduce approval delays while maintaining rigorous scientific evaluation standards. 

Belgian organisation European Heart Network (EHN) issued recommendations that mirrored Revitalised Medicine’s calls for the introduction of efficient, safe, and clearly-defined regulatory frameworks that could punctually link innovation with patients. EHN stresses that the timeliness in accessing fresh innovation when combined with a patient-centered approach to treatment is critical for those experiencing disorders, namely cardiovascular diseases. Priority regulatory pathways are crucial in improving patient outcomes, specifically in the development of orphan

devices. Rolling and priority reviews, as well as scientific advice from EU expert panels, are what drives the creation of effective protocol for medical device manufacturing and bolstering accessibility for those in need of this technology. 

In emphasising the need for a dedicated regulatory pathway for innovative medical technologies, particularly those involving advanced digital systems and emerging healthcare tools, Revitalised Medicine has proposed deeper recommendations to ensure that these frameworks evolve appropriately with respect to the devices being developed. Under the current framework, disruptive technologies such as artificial intelligence-driven diagnostics or novel digital health platforms may face regulatory processes designed for traditional devices. The organisation therefore recommends creating an EU-level innovative device designation that would allow flexible evidence generation and staged assessment procedures while ensuring appropriate safety monitoring. 

In addition, the think tank highlights the importance of strengthening early engagement between manufacturers and regulators. Revitalised Medicine notes that many regulatory delays stem from incomplete or misaligned submissions due to limited opportunities for early dialogue with notified bodies or competent authorities. To improve this process, the organisation proposes structured pre-submission consultation mechanisms that would allow manufacturers to receive scientific and regulatory guidance before formal applications are submitted, improving the quality of regulatory documentation and reducing review delays. 

Concerns about market stability and device availability have also been raised by stakeholders. Revitalised Medicine warns that increased regulatory costs and certification bottlenecks may encourage some manufacturers to withdraw existing products, particularly lower-margin or niche medical devices. The organisation therefore recommends introducing continuity provisions and priority assessment procedures for essential medical technologies to prevent shortages and ensure healthcare systems maintain access to critical diagnostic and treatment tools. 

Other stakeholders participating in the consultation process have expressed similar concerns regarding the impact of MDR and IVDR implementation on the availability of medical technologies across Europe. Industry representatives have highlighted the need to expand notified body capacity, improve regulatory clarity and strengthen coordination between national authorities to ensure consistent interpretation of EU rules. 

A stakeholder that argues for more strongly-integrated coordination for medical technology development is German Digital Therapeutics manufacturer GAIA-AG. They emphasise that medical device production frameworks need to be standardised and reformed to support optimum patient care. This would allow devices to be reclassified efficiently and in a way that bolsters healthcare innovation capacity while ensuring that patient safety is not undermined. The basis for their recommendation lies in the notion that the current regulatory design that the European Commission proposed in its policy draft does not support competitive digital solutions for patient care. The exchange of healthcare informatics is central in creating protocol that allows for effective medical technology production. Harmonisation between member states facilitates its underlying principles: Patient safety, high-quality device performance that is maintained as clinical evidence is applied, and strong risk management. As GAIA-AG is concerned that institutions can undermine these principles, interoperability between member states will suffer. Therefore, the stakeholder urges for regulations that enforce competitive standards for data sharing, applying clinical evidence into innovation, and ethical medical device manufacturing and usage. Reformed, specific regulatory frameworks that will not only improve these standards, but they will also be pivotal in minimising patient risk by considering individual needs and health issues. 

Revitalised Medicine has also focused on the importance of adapting regulatory frameworks to technologies—specifically artificial intelligence and software-based medical devices. The organisation recommends introducing adaptive lifecycle regulatory models and controlled regulatory sandboxes that allow AI-driven technologies to be tested within supervised environments before full market deployment. Such mechanisms could support innovation in digital health while ensuring continuous monitoring of safety and performance. 

Another recommendation points toward improving transparency and evidence sharing within the medical device regulatory system. Revitalised Medicine supports the development of a fully operational EUDAMED database that would allow structured publication of clinical evidence summaries and post-market surveillance data. According to the organisation, greater transparency could strengthen public trust, improve research collaboration and enhance evidence-based decision-making across the healthcare system. 

Finally, Revitalised Medicine emphasises that maintaining the global competitiveness of the European medical technology sector should remain a priority for policymakers. The organisation notes that some companies are increasingly prioritising regulatory approvals in other markets due to shorter timelines and more predictable procedures. To address this challenge, it proposes greater international regulatory alignment, including cooperation with global regulatory partners and potential mutual recognition mechanisms where safety standards are equivalent. 

Stakeholder recommendations aim to refine and align advanced MDR and IVDR frameworks among member states so that they continue to protect patient safety while also supporting innovation and ensuring that European patients have timely access to advanced medical technologies. As the European Commission continues evaluating possible reforms, input from

organisations such as Revitalised Medicine and other industry stakeholders is expected to play an important role in shaping the future of Europe’s medical device regulatory landscape.