The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is moving forward with significant reforms, emphasising digital post-market surveillance, interoperability with international standards, and a clearer path for innovation. The message is consistent: modernising regulatory processes is critical for patients to gain timely access to safe and effective medical technologies.
This mirrors priorities in the European Union. Under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), Europe has raised the bar for safety and oversight, but as a result certification processes have become more complex and resource intensive. The European Commission has called for reduced bureaucracy, stronger enforcement, and greater transparency. Team-NB, the European Association of Medical devices – Notified Bodies, has similarly expressed interest in digital harmonisation as a path to reduce application and pre-application bureaucracy.
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Electronic submissions, a move already under way in the UK, offer a practical path toward those goals. By aligning approaches across Europe and the UK, regulators and manufacturers alike can reduce duplication, accelerate reviews, and strengthen confidence in device approvals. Most importantly, patients will see the benefits through faster access to innovation.
Learning from the UK’s digital requirements
The UK’s regulatory reforms provide a valuable reference point for Europe. Under UKCA, digital post-market surveillance requirements are being built in from the start, with a focus on structured data and interoperability with international standards such as those from the International Medical Device Regulators Forum (IMDRF).
For manufacturers operating in both markets, this creates an opportunity for efficiency. If Europe introduces electronic submissions aligned with global principles, companies can avoid duplicating efforts. Data could flow more seamlessly across jurisdictions, strengthening oversight while easing the compliance burden.
The UK and EU share the same long-term goals: reducing bureaucracy, supporting innovation, and ensuring patient safety. Electronic submissions represent a practical area where greater alignment can deliver immediate benefits.
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By GlobalDataExamining eCTD as an example for standardisation
The pharmaceutical sector provides a compelling example: the electronic Common Technical Document (eCTD). Used in both the EU and US, eCTD had 94% adoption by 2022 across all FDA submissions, helping to reduce the median drug review time from 26.6 months to 9.9 months. This shorter handling time contributed to faster approvals and a 16% annual growth in submissions.
Within the medtech industry, a majority of Notified Bodies report that over half of all submissions they receive are incomplete, according to a 2025 survey. The consistent high number of incomplete submissions suggests an opportunity for structure and standardisation for the benefit of both companies and regulators.
Devices and diagnostics can follow a similar trajectory to eCTD by creating a standardised electronic data format while incorporating industry-specific frameworks like eSTAR, IMDRF, and Team-NB checklists. By streamlining processes, a standard digital submission can help both the EU and UK achieve their ambitions for efficiency and innovation.
Turning compliance into global competitiveness
Manufacturers are increasingly cautious about making Europe their first launch market. Surveys show a significant decline in EU-first strategies, with some companies prioritising faster, more predictable markets. Since the implementation of the MDR, choosing the EU as a first launch region has dropped 33% for large and 19% for SME medical device manufacturers, according to a 2024 MedTech Europe survey.
Similarly, UK firms have reported withdrawing products due to regulatory uncertainty. The ABHI Pulse of UK Healthtech survey revealed that 33% of respondents have taken products off the market in the UK. In addition, almost one in ten companies have experienced a 50% rise or more in regulatory costs.
Electronic submissions can help reverse these trends. By making approvals more predictable, transparent, and efficient, both the EU and UK can re-establish themselves as attractive regions for launching new devices while maintaining the MDR and IVDR’s increased focus on safety and effectiveness. For patients, that means quicker access to technologies that improve care. For industry, it means clearer guidelines, faster reviews, and reduced uncertainty.
Reducing bureaucracy, strengthening oversight
Both the UK and the EU face the same challenge: ensuring high standards of safety without overwhelming manufacturers or regulators with administrative burden. Today, conformity assessments consume significant resources. High certification costs and the lengthy process are reported as top reasons for manufacturers to not start conformity assessments.
Surveys show that more than half the time spent on device certification is taken up not by actual scientific evaluation but rather by administrative steps such as pre-review checks and certificate issuance. Just these two phases together can last six months or more.
Structured digital submissions can change that. By providing harmonised formats for data and documents, regulators can streamline early checks, shorten timelines, and dedicate more time to substantive review. For manufacturers, this predictability is essential to planning product launches and ensuring compliance.
Improving efficiency to save costs
Certification is costly, particularly for smaller companies. Industry data shows that 90% of initial certification costs under MDR and IVDR are tied to personnel, preparing documentation, maintaining quality systems, and managing regulatory processes.
Even modest efficiencies in submissions could save hundreds of thousands of pounds per product cycle. For manufacturers, those resources could be redirected toward R&D and patient-focused innovation.
For regulators, electronic submissions bring equally important benefits. Structured data fields, such as device characteristics, intended use, and performance data, can be reused across documentation and later for post-market surveillance. This reduces duplication and improves consistency.
Digital formats also make reviews easier to navigate, allowing faster completeness checks and better communication between reviewers and manufacturers. Over time, harmonised formats could even support analytics-driven oversight, enabling trend analysis and risk-based auditing for more consistent, focused, and efficient reviews.
Regulators also gain more complete submissions, streamlined reviews, and stronger data integrity. In short, electronic submissions help turn regulatory compliance into a competitive advantage.
Laying the digital foundation for AI and next-generation devices
Modernisation is especially urgent for software and AI-driven technologies. Software as a Medical Device (SaMD) requires frequent updates, cybersecurity documentation, and algorithm transparency. These characteristics call for a more modular, digital approach to submissions that allows for efficient updates without repeating the entire certification cycle.
AI itself offers powerful tools for regulators and industry, from detecting risks and anomalies to analysing post-market data and automating routine tasks. But AI can only function effectively when it has access to structured, high-quality data.
Standardised electronic submissions can create that digital data foundation. This could look like adopting common data dictionaries based on internationally recognised terminologies and allowing electronic data interchange formats for specific data elements to enable machine-to-machine communication.
Without harmonised formats, the potential of AI in regulation will remain largely unrealised. With them, regulators can focus resources on the most complex evaluations, improving both efficiency and consistency while supporting innovation in digital health.
Seizing the digital opportunity
The UK’s reforms and Europe’s ambitions are converging on the same goal: making regulation more efficient and predictable to support innovation. Electronic submissions are the next step in that journey. They offer a practical way to cut unnecessary bureaucracy, improve the consistency of reviews, and give both regulators and manufacturers the tools they need to keep pace with fast-evolving technologies.
Momentum is building. Pharma’s experience with eCTD shows that digital standards can transform timelines and predictability. The UK is embedding digital requirements into its regulatory reforms. The EU is openly calling for greater efficiency and transparency. The pieces are already in place. What is needed now is commitment and coordination.
Electronic submissions are not just about streamlining compliance. They are about creating the foundations for AI-enabled oversight, for digital health innovation, and for faster, safer access to medical technologies. Patients stand to benefit most, but so too does Europe’s competitiveness as a leader in medtech.
The opportunity is clear, and the technology is ready. For regulators, manufacturers, and Notified Bodies, the next step is simple: act now to make electronic submissions the standard for medical devices.
