What is the webinar about?
This webinar will provide an overview of the Annex VII Implementing Regulation (EU) 2026/977, and its impact on notified bodies and manufacturers under the EU regulatory framework (MDR/IVDR). It will present the main elements of the Implementing Regulation, including updated provisions related to quotations, timelines, management of interruptions, monitoring of performance and costs, and re-certification activities. The session will also highlight how these updates may be reflected in the conduct of conformity assessment activities.
The webinar will include considerations for manufacturers in relation to certification planning, submission readiness, and interaction with notified bodies under the updated framework.
Who should attend?
This webinar is open to anyone working at or with medical devices or In-Vitro Diagnostics manufacturers with an interest in gaining thorough understanding of Annex VII implementing regulation requirements and its practical application in the conformity assessment activities of notified bodies.
This includes:
Regulatory & Compliance professionals
- Regulatory Affairs Leads / Specialists
- Compliance officers
- Quality Assurance managers
Quality Management System (QMS) owners
- QMS managers
- Internal auditors
Clinical, technical, and product experts
- Clinical evaluation / clinical affairs teams
- R&D / product development
Leadership & decision-makers
- Regulatory leadership (e.g., Heads/Directors)
- Program/project managers for MDR/IVDR
External stakeholders
- Consultants supporting MDR/IVDR compliance
- Legal advisors in medical devices/IVD industries
What will participants gain?
Attendees will leave with:
- A clear understanding of requirements of Annex VII implementing act.
- Considerations to support manufacturers’ awareness on how can prepare themselves to work effectively with their notified body for successful implementation of the Annex VII requirements.
Speakers
