On December 16, 2025, a proposal for a major update to the Medical Device Regulation was released. While it is not yet in force and is expected to be voted on by Q2 2027, the proposal has foreseeable impacts on ongoing submissions, timelines, and how organizations future proof their MDR strategies.
Objective
With a focus on MDR and AI related topics, participants will:
- Learn how to read and interpret the proposal independently
- Be able to explain anticipated changes to the MDR submission and maintenance process to management teams
- Understand the expected impacts on clinical evaluation, well established devices, and clinical data requirements
- See how the proposal fits within the context of Article 120 extensions
Agenda
- Introduction to the proposal and what this release is and is not
- Understanding the proposal and how to read it
- Key changes and their impact on legal manufacturers of medical devices and IVDs
- Action items and what to do now
- Q&A
Target Audience
- Consultants navigating the evolving regulatory landscape
- Regulatory affairs specialists and leaders seeking clarity on timelines and impacts
- Implementation teams responsible for executing regulatory changes
Language: English
Cost: No charge
Cannot make a live session? Register now and receive a complimentary recording after the live event.
Speakers
Kevin Holochwost
Director, Technical Assessment, SGS North America
Kevin Holochwost has worked in the regulatory industry within notified bodies for more than a decade and has over 20 years of experience designing software and hardware systems for medical devices. Earlier in his career, he worked as a physicist and statistician.
Balázs Bozsik
Technical Director, Medical Audit, SGS
Balázs Bozsik is the Technical Director for the Medical Audit team at SGS North America. He holds a degree in integrated mechanical engineering from the Budapest University of Technology and Economics. His background includes manufacturing technology and design engineering in medical imaging, automotive, and consumer lighting industries. Prior to joining SGS, he spent over 14 years with another TIC organization, serving as Global MDSAP Program Manager, certification officer, product specialist for active medical devices and medical software, and medical auditor across major certification schemes.
Greg Jacobson
Vice President, Sales, Medical Division, SGS North America
Greg Jacobson is Vice President of Sales for the medical division at SGS North America. He contributes to strategic planning, resource alignment, and sales process improvement to enhance client satisfaction. Greg has extensive experience in medical device certification sales and has managed high risk device accounts for more than a decade, along with holding leadership sales roles both within and outside the TIC industry.