EU MDR/IVDR Overhaul: Simplifying Medical Device Compliance & Fostering Innovation
Region: European Union
Notification Date: 2026-01-16
The European Union has notified the WTO of a significant proposal to amend Regulations (EU) 2017/745 (Medical Device Regulation – MDR) and (EU) 2017/746 (In Vitro Diagnostic Medical Device Regulation – IVDR). This initiative aims to streamline and future-proof the regulatory framework for medical devices. Its core objective is to simplify rules, reduce administrative burden on manufacturers, and enhance the predictability and cost-efficiency of certification procedures, all while maintaining a high level of public health protection and patient safety.
Key Details- Country: European Union
- Document Symbol: G/TBT/N/EU/1184
- Notification Date: 2026-01-16
- Comment Deadline: Not specified
- Effective Date: To be determined (20th day following publication in the Official Journal)
The proposed Regulation introduces targeted amendments across several key areas of medical device and IVD regulation:
- Simplification & Proportionality: Reduced qualification requirements for Persons Responsible for Regulatory Compliance (PRRC) and increased flexibility for SMEs. Certificate validity periods are no longer strictly capped at 5 years, transitioning to periodic reviews based on device risk. Clinical evidence requirements are broadened to accept a wider range of data, including non-clinical data and in silico testing, and a new definition for 'well-established technology devices' is introduced to apply proportionate requirements. Rules for repackaging and relabelling are also streamlined.
- Reduction of Administrative Burden: The scope for Summary of Safety and Clinical Performance (SSCP) is reduced, and separate validation by Notified Bodies is no longer required. The frequency for updating Periodic Safety Update Reports (PSURs) is decreased, and reporting timelines for non-public health serious incidents are extended to 30 days.
- Innovation & Availability: New criteria and expedited conformity assessment pathways are established for breakthrough and orphan devices. Conditions for 'in-house' manufactured devices by health institutions are made more flexible, including allowance for transfer between institutions and removal of the 'no equivalent device' condition for IVDs. Member States and the Commission can also establish regulatory sandboxes to foster emerging technologies.
- Predictability & Cost-Efficiency of Certification: Notified Body involvement in conformity assessment is reduced for lower and medium-risk devices. Remote audits are now permissible, and surveillance audits may occur every two years, where justified. Notified Body fees are subject to reductions for micro/small manufacturers and orphan devices, with the Commission empowered to set fee structures.
- Digitalisation: The proposal promotes the use of digital formats for declarations of conformity, label information, instructions for use, and electronic submission of all required information. Provisions for Unique Device Identification (UDI) and the Eudamed database are clarified and enhanced.
- International Cooperation: A new section promotes global regulatory convergence through participation in international fora like IMDRF and MDSAP, aiming to leverage assessments from third-country regulatory authorities.
- Cross-Sector Coherence: Procedures for combined studies (medical devices and medicinal products) are simplified, allowing for single applications. Explicit cybersecurity requirements, aligning with the EU AI Act, are introduced for connected devices, requiring reporting of exploited vulnerabilities.
This proposal is expected to significantly affect manufacturers of medical devices and in vitro diagnostic medical devices, particularly SMEs, by alleviating disproportionate compliance costs and administrative burdens. The streamlined processes and enhanced predictability aim to improve market access and support innovation, especially for breakthrough and orphan devices. For international trade, the promotion of global regulatory convergence could simplify market entry and reduce duplicative efforts for manufacturers operating in multiple jurisdictions. The revised framework seeks to maintain EU competitiveness and ensure a consistent supply of safe, high-quality devices.
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