- New research finds that 87% of medical technologies lack consistent methods for sharing product information between global regulatory teams
Increasing regulatory complexity drives the need for a single source of regulatory information
BARCELONA, Spain, Nov. 15, 2023/PRNewswire/ -- Most medtech companies (87%) cannot seamlessly exchange product information between national and global regulatory assurance teams, according to the 2023 Regulatory Benchmark Report by Veeva MedTech. Without a standardized and consistent way to share documents globally, organizations cannot guarantee the reliability or accuracy of product information across markets. This increases compliance risk and can delay delivery of devices and diagnostics to patients.
A single source of regulatory documents can enable global teams to access real-time information and take proactive action. However, more than half of respondents (56%) say they do not have access to a single source of documents supporting global presentations. As regulations, such as the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), continue to evolve, establishing centralized data and regulatory documents should be a top priority to accelerate approvals and accelerate the entry of new markets.
The report reveals additional opportunities to improve medical technology regulatory affairs, including:
"As companies scale and expand into global markets, having accurate, real-time product information can significantly streamline national regulatory filings," said Seth Goldenberg, vice president of Veeva MedTech. "The research reveals a significant opportunity for medical technologies to unify global regulatory information, a change that can empower regulatory affairs with data for faster approvals."
The Veeva MedTech Regulatory Benchmark Report 2023 examines the medical device and diagnostics industry's progress toward modernizing regulatory operations. Respondents include more than 100 regulatory affairs (RA) professionals from medical technology organizations around the world. View the full annual study, which explores how medtech companies and AR teams work cross-functionally to manage new product development, global market entry, commercial launches, and product certification renewal.
About Veeva Systems Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva serves more than 1,000 customers, from the world's largest biopharmaceutical companies to emerging biotech companies. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves. For more information, visit veeva.com/eu.
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