Regulatory Intelligence – a core task of Regulatory Affairs?

Many companies consider Regulatory Intelligence so important that they create their own roles and departments for it.

This article clarifies what Regulatory Intelligence is, how companies can benefit from it, and where tools can provide support.

1. What is “Regulatory Intelligence”?

This includes gathering and analyzing regulatory information from various sources, including regulatory agencies, industry associations, and scientific literature.

2. What is the goal of Regulatory Intelligence?

The goal of Regulatory Intelligence at manufacturers is to provide executives with the latest information on an ongoing basis. They need this to make informed decisions in the following areas:

• Deciding on medical devices to develop
• Determine which markets to bring products to and in what order
• Determine the current and future regulatory requirements in these markets
• Decide whether to participate in or object to planned regulations
• Estimate efforts, durations, and costs to meet regulatory requirements
• Ensure that the necessary staff with the required skills and competencies are in place
• Plan and organize additional resources (service providers, tools, financial resources)

3. Who benefits from Regulatory Intelligence?

Regulatory Intelligence is important to a wide range of stakeholders involved in the development, manufacturing, distribution, monitoring, and regulation of medical devices. These include medical device manufacturers, regulatory affairs professionals, clinical researchers, and healthcare providers (see Tab. 1).

role, stakeholders	demand for Regulatory Intelligence
manufacturers	see list in section 2
healthcare providers	– decide on the purchase of medical devices – operate products in compliance with the law – inform patients in accordance with the law – assess safety, performance, and availability of medical devices
authorities, notified bodies	– prepare own employees for future requirements – inform manufacturers about these requirements – ensure conformity of products and manufacturers during approval and market surveillance
clinical researchers	– understand regulatory requirements – select markets for clinical investigations – plan and conduct clinical investigations in compliance with regulatory requirements
legislator	– coordinate own plans with other legislators – model and anticipate the effects of regulation (see Regulatory Science)

4. What data is collected and where?

a) Content

In order to achieve the above objectives, all regulatory-relevant content must be collected:

• new requirements or new versions of regulatory requirements such as standards, laws, guidelines, regulations, policies, best practices, etc.
• type of changes
• effective date and transition periods
• announcement of regulatory changes
• calls for comments or the creation of regulatory-related documents

b) Sources

Sources now primarily include:

• websites and documents published there
• web-based databases
• newsletters
• online forums
• social media

Publications in printed publications such as magazines are rarer. Physical circulars and notices are the exceptions.

Some information is not official but can only be obtained through personal contacts.

5. Are there tools for Regulatory Intelligence?

For medical devices, there are services and software applications that support the collection and evaluation of regulatory information.

These services perform many tasks for clients (e.g., manufacturers), such as collecting, (pre)evaluating, and filtering information. They also provide support in deriving the necessary measures.

Implementing these measures is always the task of the respective client (see Tab. 2).

task	service provider	client/customer (manufacturer, authority, notified body)
collect information	X
(pre)evaluate information	X
filter information for client	X
decide on measures	X	X
implement measures	(X)	X
track implementation	(X)	X

Examples of measures include:

• Adapt standard operation precedures and other specification documents
• Perform gap analyses to verify product and organizational compliance with current versions of regulatory documents
• Update regulatory strategies (e.g., sequence of target markets)
• Inform or/and qualify employees and suppliers

6. Summary and conclusion

Overall, Regulatory Intelligence plays a critical role in meeting the duty,

• to keep stakeholders informed of regulatory requirements and changes in the medical device industry and to
• to take the necessary action.

By providing access to regulatory information and analysis, tools help stakeholders make informed decisions about medical device development, regulatory compliance, and market access to gain a competitive advantage.

For most organizations, it makes good business sense to outsource work to service providers to benefit from “leverage” and higher-quality search results.