RAPS Regulatory Convergence 2025: Global Changes and Global Change Management

Ken Pilgrim and Evangeline Loh

Managing change in a medical device company or its products is challenging. During RAPS 2025, we discussed how assessing global changes can be complicated and involves strategic considerations, including understanding regulatory requirements and requisite regulatory documents. This helps identify dependencies and timelines.

Quality management systems

Manufacturers should rely on their Quality Management System (QMS). The quality planning process (ISO 13485 §4.1.1, 5.4) should be leveraged to manage and track activities and status. A Quality Plan should be developed, and the relevant representatives convened to identify activities that must be considered, delineated, coordinated and completed as part of the change. Additionally, within the QMS, manufacturers should utilize templates for regulatory assessments. 

Emergo by UL’s session focused on two major categories of change management: global organizational change and global device change. 

Global organizational changes

These changes are typically related to the legal manufacturer of a device, although not to the device itself or its design. Examples can include mergers and acquisitions (M&A), change in moniker, ownership, address, change in-country representative, new site location for QMS activities, or new or revised QMS certificates. 

Emergo by UL has noted an increase in strategic regulatory assessments related to M&A. In general, most changes will have a regulatory impact, requiring updates to authorizations in each country where the devices are placed on the market. To support adherence to the Transition Service Agreements, parties to a M&A should perform thorough due diligence and regulatory assessments. 

Global device changes

Device changes are related to the device and can include brand name, identifier, device design and device manufacturing. Even more than organizational changes, device changes can have a regulatory impact that requires updates to existing authorizations or new registrations. 

These device changes can be considered minor or significant. Additionally, the definition of “significant” can vary among regulatory jurisdictions.

Regulatory assessments for changes

A regulatory assessment for either change describes the scope and the rationale for the change. The impacted markets are identified, and the regulatory requirements, submissions required (including amendments or new submissions), and timelines are discussed. The most complex assessments are typically related to countries with explicit QMS legislation, which requires specific QMS certificates. The output of the regulatory assessment often needs to include a detailed regulatory and clinical strategy.  

Concluding remarks

It is Emergo by UL’s experience that these regulatory changes are assessed individually and by market. Every change is unique, and every regulatory system is different. Understanding the nuances is critical to supporting success; therefore, a company’s regulatory intelligence capability is also a vital resource. 

In Emergo by UL’s next Regulatory Insight, we present QMS and regulatory recommendations related to changes.