EU MDR Implementation and Organizational Change Management Webinar

As a result of the COVID-19 pandemic, the European Commission (EC) accepted a proposal to postpone the EU MDR application date. While this reprieve may be welcome for manufacturers who have delayed implementation or are still working through their assessments, it should not slow the momentum towards full implementation.

Navigating EU MDR Implementation

The regulation changes can seem overwhelming, but defining a strategy to manage changes across the organization and multiple systems provides a practical pathway to implementation. This 20-minute webinar from AssurX offers a high-level perspective on crucial MDR changes and interdependencies across the product lifecycle.

Key Focus Areas of the Webinar

• Impact of MDR Oversight Changes: Understand the impact of changes in MDR oversight by Notified Bodies and how they affect compliance strategies.
• Technology Transition Considerations: Explore considerations for technology transitions, including the interaction of Quality Management Systems (QMS) with other systems.
• Expanding Manufacturer Responsibilities: Learn about the expansion of manufacturer responsibilities under the new MDR regulations.
• Implementing Post-Market Surveillance: Discover how to implement post-market surveillance that supports continuous product evaluation and improvement.
• EU MDR Organizational Change Management: Navigate the organizational change management journey map to ensure successful implementation.
• Supporting EU MDR Requirements: Identify solutions that support EU MDR requirements and facilitate compliance across the organization.

By focusing on these key areas, organizations can effectively manage the transition to EU MDR compliance, ensuring they remain competitive and compliant in a changing regulatory landscape.