Sponsored Webcast: The Next Evolution of MDR: How the New Annex VII Requirements Will Change MDR Certification

Updates to Annex VII of the EU MDR 2017/745 reshape notified body requirements and their impact on manufacturers. This webcast reviews the changes, their rationale, and implications for organizational structures, competencies, certification activities, and timelines, providing practical insights to support MDR compliance and certification readiness.

11am – 12pm EDT 28 October 2026 + Add to calendar

The recent revisions to Annex VII of the Medical Device Regulation (EU) 2017/745 represent one of the most significant changes to notified body requirements since the MDR entered into application. While many of the new provisions are directed at notified bodies, their impact will extend well beyond designation and oversight, influencing how manufacturers prepare for and experience the conformity assessment process.

This webcast will provide an overview of the new Annex VII requirements, explain the rationale behind the changes, and examine their practical implications for both manufacturers and notified bodies. Attendees will gain insight into how these revisions may affect organizational structures, competency expectations, conformity assessment activities, and certification timelines, along with practical considerations for successfully preparing for the next evolution of MDR certification.

Learning Objectives:

Upon completion of this webcast, attendees will be able to:

Describe the key changes introduced in the revised Annex VII of MDR (EU) 2017/745 and the regulatory rationale behind these new requirements.
Evaluate the potential impact of the revised Annex VII requirements on notified body operations, manufacturer interactions, and the conformity assessment process.
Identify practical actions manufacturers can take to prepare for implementation of the new Annex VII requirements and minimize disruption to certification activities.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend:

This session is intended for professionals involved in EU MDR compliance, certification, and conformity assessment activities, including:

Medical device manufacturers across regulatory affairs, quality assurance, clinical affairs, and compliance functions.
Regulatory consultants supporting MDR implementation, certification, and regulatory strategy.
Executives and functional leaders responsible for regulatory planning, certification readiness, and notified body engagement.

Participants should have a foundational understanding of the EU Medical Device Regulation (EU) 2017/745 and an interest in learning how the revised Annex VII requirements may influence future conformity assessment and certification processes.