Veeva Systems  announced findings from the 2025 Veeva Medtech Regulatory Affairs Benchmark, revealing that 50% of respondents lack full confidence in the completeness of their underlying data for global product registrations. Many organizations are manually reconciling data to ensure regulatory compliance, increasing the administrative burden for regulatory affairs teams. 

With the rise of new technology to streamline and automate regulatory processes, high data quality is paramount for medtech innovation. When considering effective AI implementation, only 17% rate their regulatory data quality as excellent, with the remainder categorizing it as average or worse.

The report from Veeva MedTech examines the current state of regulatory operations, including:

• Lengthy timelines for submission preparation. From data gathering to internal approval, preparing a submission for a 510(k) takes a month or longer for 80% of respondents, with 24% indicating that it takes more than six months. With organizations spending up to two years on each MDR submission, medtechs that reduce submission timelines can get products to market faster with considerable cost and resource savings.
• Prioritizing time to market measurement. Only 5% of those surveyed use a fully automated process to monitor time to market, a key metric for effective resource planning. About two-thirds (67%) partially or entirely rely on manual processes, making it difficult to generate accurate and timely performance insights.
• Room for regulatory operational improvement. Respondents identified heavy administrative burden (61%), siloed processes (49%), digital tool proficiency (35%), and educational shortcomings (24%) as the largest gaps in regulatory affairs, all of which may hinder product registrations and slow time to market.
• Technology advancing regulatory affairs. More organizations are making strategic decisions to improve efficiency and compliance, with 56% planning to adopt a regulatory information management (RIM) system. Nearly half of respondents are looking to develop integrations between existing systems (52%) or implement automated submission tracking and reporting tools (48%) to gain unified, accessible data.

"The report illustrates key areas to evolve regulatory affairs to a strategic enabler of business objectives through connected, automated processes for increased data reliability and speed," says Seth Goldenberg, president, Veeva MedTech. "As teams are asked to do more with the same resources, addressing operational gaps to foster agility while maintaining compliance in the evolving regulatory landscape will be critical."

The 2025 Medtech Regulatory Affairs Benchmark surveyed a diverse group of 130 regulatory professionals, exploring the most critical challenges facing regulatory teams today.