REALM Project Feedback on MDR/IVDR Regulations

The REALM project, dedicated to fostering responsible innovation in the health and life sciences, actively contributed to the European Commission’s recent public consultation as part of its targeted evaluation of the EU regulatory framework for Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This initiative represents a crucial opportunity to reflect on the effectiveness of existing regulations and to ensure they remain fit for purpose in a rapidly evolving technological and scientific landscape. As a research and innovation initiative involving diverse stakeholders across Europe, the REALM consortium welcomed the opportunity to contribute evidence-based insights and practical recommendations aimed at improving the effectiveness and adaptability of the regulatory environment.

In their feedback, the REALM consortium emphasized the need to strike a balance between safeguarding patient safety and supporting innovation, especially in rapidly evolving technological fields such as software-based medical devices, genomics, and artificial intelligence (AI). Drawing on the consortium’s collective expertise and hands-on experience with regulatory compliance in innovative health solutions, they highlighted key concerns and proposed actionable improvements. These include enhanced regulatory clarity, better alignment between overlapping frameworks, and specific support mechanisms for SMEs, which form a critical engine of innovation in the European medical technology ecosystem.

The following sections summarize the main points of feedback submitted by the REALM consortium, structured around general observations, domain-specific concerns, and concrete recommendations for future policy development.

General Remarks:

1. Classification of Software as Medical Devices: The current classification system for software as medical devices (SaMD) lacks nuance. A more detailed classification based on the specific application of the software is necessary to ensure appropriate regulation.
2. Support for SMEs: Small and medium-sized enterprises (SMEs) face significant challenges under the current MDR/IVDR frameworks. The high costs and lengthy timelines for compliance disproportionately affect SMEs, stifling innovation. A pathway similar to the US 510(k) process could help maintain technological advancements within the EU.
3. Cost Implications: The additional costs imposed by the new MDR requirements increase the price of healthcare solutions, exacerbating existing financial pressures on hospitals and care providers. Regulators must balance safety measures with cost considerations to avoid further burdening the healthcare system.

MDR Regulations and Software as Medical Devices In the EU with the focus on Genomics and Pharmacogenomics:

1. Genomics and Pharmacogenomics: The MDR does not adequately address software used for genomics and pharmacogenomics applications. These technologies are crucial for personalized medicine, yet the lack of specific regulations delays their implementation and patient access.
2. Risk-Based Classification: The current risk-based classification system does not fully account for the unique risks associated with genomics and pharmacogenomics software. Clearer guidelines are needed to ensure appropriate regulatory scrutiny.

Overlapping Regulatory Frameworks of MDR/IVDR and AI Act:

1. Terminological Differences: The AI Act and MDR/IVDR use different terminologies for equivalent roles, creating confusion. Harmonizing these terms would improve clarity and compliance.
2. Quality Management Systems (QMS): The QMS requirements under the AI Act and MDR/IVDR should be aligned to avoid unnecessary burdens on businesses. Consistent guidelines would help manufacturers meet both sets of regulations efficiently.

Recommendations and conclusions:

1. Tailored Guidelines: The European Commission should develop specific guidance documents for genomics and pharmacogenomics software, addressing classification, performance evaluation, and post-market surveillance.
2. Risk Stratification: Dedicated classification criteria based on the clinical impact of genomic data misinterpretation should be established to ensure proportionate regulatory scrutiny.
3. Collaboration and Harmonization: Ongoing dialogue among regulators, industry experts, healthcare professionals, and patient groups is essential. Learning from best practices in other jurisdictions, such as the FDA's approach to genomic medicine, can help refine the EU's regulatory framework.
4. Bridging MDR and IVDR: Closer coordination between MDR and IVDR requirements is necessary to reduce duplication and ensure consistent standards of safety and effectiveness.
5. Improved Regulatory Clarity: the REALM project emphasizes the need for targeted guidance and regulatory clarity to support the development and implementation of innovative medical technologies.
6. Consistent Regulatory Framework Encompassing AI Act and MDR/ IVDR: The Commission should better align existing regulatory frameworks for novel technologies used in the development and deployment of medical devices and in vitro medical devices.
7. Improved Rules Which Address the Specific Situation of SMEs in the Medical Devices Sector: Consideration should be given to reducing regulatory burdens for SMEs in order to support innovation in the European medical devices industry.