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2023 MedTech Regulatory Performance Report

Insights and process benchmarks from 200 medtech regulatory affairs professionals across North America and Europe.

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In the midst of growing regulatory complexity, are regulatory affairs teams and processes keeping pace? How should RA teams be staffed? How long should it take to complete a registration or license renewal?

The regulatory performance report takes a deep look into the state of medtech regulatory affairs to answer these and many more critical questions.

Read on to see how your organization stacks up.

Team Size and Staffing

56% of medtech companies have less than 10 full-time employees focused on regulatory affairs. While RA leaders are satisfied with resourcing, front-line employees are feeling the pressure. Headcount planning decisions rarely take into account anticipated workload.


Time to complete regulatory activities

Average time to complete a license renewal

Average time to complete a license update

Average time to complete a new market submission

The average medtech company completes 50 license renewals, 50 license updates, and 10 new market submissions each year. More than half of these projects take more than 4 months to complete. New market submissions often have 7 or more turn-arounds with health authorities.


Non-compliance issues in the past two years

Over half of regulatory professionals believe they have the capabilities and processes in place to execute effectively. Yet 61% reported a major non-compliance incident in the past 2 years, with many incurring costs over $1,000,000.

Technology Adoption

Software productivity gains

Regulatory information management

Quality management systems (eQMS)

Regulatory intelligence services/databases

Product lifecycle management (PLM)

Very High




88% of medtech companies have adopted tools that are designed to support regulatory and regulatory-adjacent processes (RIM, eQMS, PLM, Regulatory intelligence). Of these investments, RIM systems provide the highest productivity gains.

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Unlock the full report to read more about regulatory planning, process efficiently, and the impact of technology on medtech regulatory affairs.

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Man in MRI machine
Medical researchers