Notification of Changes: How and What to Notify

Join our expert-led webinar to gain a clear understanding of the Notification of Changes (NoC) process, including the updated submission flowchart and documentation requirements.

This webinar is designed to help medical device (MD) and in vitro diagnostic (IVD) medical device manufacturers work more efficiently with notified bodies, ensuring that changes are adequately communicated and assessed smoothly.

Whether you are preparing to submit a change notification or looking to optimize your regulatory processes, this webinar will provide you with practical guidance and up-to-date insights. You will leave with a clearer roadmap for submissions, reducing delays and improving compliance outcomes.

Objectives

• Improve and streamline the NoC process for both MD and IVD manufacturers certified by SGS Belgium NB1639
• Provide clarity on required documentation and submission timelines
• Enhance understanding of the assessment procedure to avoid common pitfalls

Agenda

• Introduction of the submission flowchart and timeline
• NoC documents and changes
• Assessment procedure
• Q&A

Target Audience

This webinar is for NB1639 certified MD and IVD manufacturers operating under ISO 13485, MDD, MDR, IVDR, UKCA and MDSAP schemes.

Language: English

Cost: No charge

There will be two sessions of this webinar:

• Session one: October 2, 10 AM CEST
• Session two: October 2, 9 AM EDT

Can't make a live session? Register now and receive a complimentary recording after the live event.

Speaker

Sabína Sedlačková
Global Medical Devices Technical Coordinator Team Leader, SGS

Sabina holds a master’s degree in bioanalytics and has extensive experience in the laboratory and medical device industries. For over three years, she has led contract reviews and provided technical coordination, managing daily notifications of change from manufacturers.