Europe Embraces Electronic Submissions for Medical Device Regulation
Brussels, Saturday, 13 September 2025.
The shift to electronic submissions in Europe promises to reduce regulatory burdens, accelerating market access for medical devices by cutting assessment times by over 30%.
Streamlining Approval Processes
The European medical device industry is undergoing a transformation with a shift towards electronic submissions, driven by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). These regulations aim to reduce the time spent on conformity assessments, which currently consume over 50% of the total assessment time in the ‘pre-review’ and ‘certificate issuance’ phases. By optimizing the pre-submission phase, manufacturers can potentially reduce assessment times by over 30%, allowing products to reach the market up to three months earlier [1].
Economic Implications for Manufacturers
The financial burden on manufacturers under the MDR and IVDR is significant, with 90% of the total costs in the first year allocated to personnel involved in Quality Management Systems (QMS), technical documentation, and certification processes. The adoption of electronic submissions promises to streamline these processes, thereby reducing personnel costs and easing the financial strain on manufacturers [1]. This shift is crucial as the MedTech Europe 2024 Regulatory Survey indicates a 40% decrease in large manufacturers choosing the EU as their first market due to these burdens [1].
Standardization and Global Alignment
A key component of this regulatory evolution is the standardization of electronic data formats, which aligns with international efforts such as those by the International Medical Device Regulators Forum (IMDRF). The European Commission has called for a robust governance framework to oversee the implementation of a pan-European electronic submission system, involving representatives from the European Commission, national competent authorities, Notified Bodies, and industry associations [1]. This framework is expected to foster a more efficient, predictable, and competitive regulatory landscape [1].
Future Outlook and Industry Impact
The transition to electronic submissions is not just about reducing timelines and costs; it also enhances trust and enforcement across the medical device industry in Europe. As the European Parliament emphasizes the need to address bottlenecks in the MDR and IVDR implementation, the move towards digital solutions appears to be a step in the right direction [1]. As these systems become more widespread, the European medical device sector is poised for significant growth and innovation, ultimately benefiting manufacturers, reviewers, and patients alike [1].