SURVEY: Managing Global Regulatory Strategy and Compliance – Assessment of Status, Gaps and Needs.

More resources, expertise and technology, please!

A common theme illustrated in a recent survey of medical device regulatory professionals is the need for more resources, expertise and technology. The data confirms industry concerns about increasing workloads and overtime, and how many companies are struggling to recruit suitably qualified RA/QA associates. Many medical device companies are questioning their regulatory competence and resource availability due to increasing complexity and changing compliance requirements.

Meeting regulatory priorities for 2024

Regulatory fatigue… are we there yet?

An April 2024 survey of medical device companies shows the industry is rapidly heading toward regulatory fatigue due to resource constraints, ever-changing global policies, and under-utilization of digital technologies/processes. The survey was conducted by online media company MedTechIntelligence.com in partnership with regulatory services and solutions provider Celegence.

Summary of findings:

Medical device manufacturers struggle to meet regulatory requirements.
The need to mitigate risk increases as the complexity of regulatory compliance increases around the world.
MDR/IVDR remains a priority and requires investment.
Even though businesses lack bandwidth, organizations are wary of using external resources due to preconceived notions about outsourcing.

Compliance capabilities

While just over a third of respondents consider their organizations’ compliance monitoring and regulatory intelligence capabilities to be strategic and comprehensive, 65% rate their overall capabilities as new, minimal, and reactive. They rely heavily on manual research and often react to changes rather than proactively manage compliance.

Only 6% of all respondents say their regulatory expertise and compliance processes are comprehensive, while almost a third say they have the right processes in place but may not fully understand the implications of changing requirements. The overall response is that the industry needs more regulatory resources, expertise and technology. The survey further explores these needs, where gaps remain and where additional assistance would be most beneficial.

Get the full summary report

About the author

Celegency

Celegence offers services and solutions that support the life sciences industry with regulatory operations and strategies.

As regulatory specialists, we operate across all stages of the product lifecycle, from regulatory strategy, development and all aspects of established product maintenance, including submission management, publishing and interactions with health authorities. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence.

Our mission is to partner with our clients to deliver regulatory efficiencies that allow them to focus on what matters most: delivering exceptional patient value. We support companies in achieving regulatory compliance worldwide by providing fully trained resources who understand the regulations and can use that knowledge to help our clients in their daily operations.

About the author

MedTech Intelligence employees

This Medical interview The team consists of independent journalists and industry writers with many years of experience reporting on medical device issues in terms of business, market trends, product development, quality, regulation and operations.

You can contact our editors via our contact page.