MDR & IVDR Revision Resolution Passed by the EU Parliament
- Date
- October 24, 2024
- Category
EU Regulations
- Description
On October 23, 2024, in a significant move reflecting the evolving landscape of medical devices and in vitro diagnostic regulations, the European Parliament has passed a resolution emphasising the urgent need for a revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This resolution comes in response to various challenges faced by manufacturers leading to concerns as to their ability to meet deadlines to transition their products to the new regulations.
The MDR and IVDR, which came into full effect in May 2021 and May 2022 respectively, were established to enhance patient safety and ensure that medical devices and in vitro diagnostics meet high standards of quality and efficacy. While these regulations aimed to address past shortcomings and improve oversight, they have also introduced complexities that have raised concerns across the healthcare sector and the impact on patients. As a result of the resolution, the European Commission will not only propose changes to the regulations but will conduct an impact assessment in early 2025. Unfortunately, due to other political pressures brought on by external parties, there hasn’t been a confirmation of when the revisions to the regulations will be completed. The European People's Party Group (EPP), who initiated the resolution effort, has expressed that it would want the changes to be implemented by the third quarter of 2025 and is supported by the lobby group MedTech Europe, both citing the urgency for immediate action.
Manufacturers have reported significant delays in obtaining necessary certifications, leading to concerns about the availability of essential medical devices and diagnostics in the market. The backlog at notified bodies has exacerbated this issue. Small and medium-sized enterprises (SMEs) have been particularly hard hit, facing increased compliance costs that may hinder innovation and limit market access. The resolution underscores the need for measures that support these businesses, ensuring a competitive environment. Stakeholders have criticised the complexity of the current regulatory framework, which can lead to confusion and inconsistencies in implementation. Simplifying and streamlining processes is seen as essential to facilitate compliance and improve overall efficiency. Further delays in bringing new technologies to market directly affects patient care, as advancements in medical technology continue to grow, timely access to innovative devices is crucial for improving health outcomes.
The resolution calls for a comprehensive review of the MDR and IVDR to address these pressing challenges including,
- Ensuring the availability of resources for notified bodies to implement regulations, establishing clearer guidelines to reduce approval times for medical devices and diagnostics, and transparency of fee structures.
- Implementing financial and administrative support systems aimed at helping SMEs navigate the regulatory landscape and reducing administrative burdens.
- Establishing clearer lines of communication between manufacturers, regulatory bodies, and healthcare professionals to ensure that all stakeholders are informed about requirements, assessment timelines and costs.
- Instituting a robust framework for the ongoing monitoring and evaluation of the regulations to ensure they remain relevant and eliminating unnecessary recertifications.
Since their inception, the MDR and IVDR have been plagued with delays and revised timelines for compliance. The resolution marks an important step towards addressing the challenges posed by the MDR and IVDR and by recognising the urgent need for revision, lawmakers are taking proactive measures to ensure that the regulatory framework supports both patient safety and the innovation of medical technologies.