Webinar
Medical Devices

Annex VII Implementing Regulation (EU) 2026/977

This webinar will provide an overview of the Annex VII Implementing Regulation (EU) 2026/977, and its impact on notified bodies and manufacturers.

Watch the Webinar

Implementing Regulation (EU) 2026/977 entered into force on 25 May.

How should you prepare? Our Annex VII webinar will prepare and provide you with:

A clear understanding of requirements of Annex VII implementing act.
Annex VII's impact on notified bodies and manufacturers under the EU regulatory framework (MDR/IVDR).
Main elements of the Implementing Regulation.
How manufacturers can prepare themselves to work effectively with their notified body.

Speakers

Hear from the experts in this webinar

Speaker

Shruti Gangwal

Regulatory Lead, BSI

Speaker

Sofia Palm

Associate Head of Medical Devices Notified Body

Additional information about the webinar

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.
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.

Including:

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
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.