Navigating the Latest Developments in the Medical Device Regulations Landscape - Event closed.
Join us for an exclusive complimentary in-person seminar on 6th October 2026 – Hyatt Centric Cambridge
MDR & IVDR regulations: Are you ready?
The MDR and IVDR set clear standards for medical devices and diagnostics, yet many companies are still uncertain about their progress toward compliance. Perhaps you find yourself in a similar situation: initial steps have been taken, but a clear overview is still lacking.
- What exactly applies to your company?
- Where are the gaps?
- And what should be prioritised now?
Join us.
As a trusted notified body, we understand the challenges you face. We are bringing together medical device manufacturers, regulatory professionals, auditors and certification experts for a full day of knowledge sharing, practical insights and networking.
Join the waiting list for our in-person events.
During our seminars, you will have the opportunity to speak directly and in person with our experts. It will be your opportunity to:
✓ Discuss your specific questions with certification and regulatory specialists
✓ Exchange with industry peers facing similar regulatory challenges
✓ Gain practical updates on MDR & IVDR requirements
✓ Explore best practices to support your certification strategy
Participation is free of charge.
Seats are limited, so early registration is strongly recommended.
Photo and video notice: Please note that photos and video recordings may be taken during the seminar and may be used for event-related communication and promotional purposes. By attending, you agree to the use of such recordings. If you prefer not to be photographed or filmed, please let a member of the event team know.
On the day of the seminar, the programme will begin in a relaxed atmosphere with morning coffee, giving participants the opportunity to connect and network from the very start.
Throughout the seminar, our experts will present and discuss key topics including:
- MDR and IVDR developments
- Certification processes and timelines
- Testing capabilities and laboratory services
- Practical guidance for manufacturers navigating regulatory requirements
The seminar will provide practical insights and actionable strategies to help participants assess their current position, address implementation challenges, and gain clarity on the way forward.
Location details:
Hyatt Centric Cambridge
37 Eddington Avenue,
Cambridge,
CB3 1SE
UK
Please note: Parking is available at this location. It may be free or subject to additional fees.
Our Agenda
Agenda for the day will follow:
08:30 - 09:00
Arrival & Welcome of attendees + coffee time
09:00 - 10:30
MDR and IVDR regulatory update: timelines and re-certification, MDR/IVDR 2.0 proposal, Class IIb implantable well-established devices – extension of the list
10:30 - 11:00
Break Time
11:00 - 12:00
IVDR transitional periods: current regulatory requirements, key considerations
12:00 - 13:00
Lunch Time
13:00 - 14:00
Notified Body change process: transfer of certification, transfer of application for conformity assessment procedure
14:00 - 15:00
EUDAMED: timelines for mandatory use, registration of devices, registration of certificates
15:00 - 16:00
Networking, coffee & questions with the experts
16:00
End
Our Experts
Maciej Ściera | TÜV Rheinland LGA Products
Global Scheme Manager
Maciej Ściera serves as the Global Scheme Manager for ISO 13485 & MDR at TÜV Rheinland, overseeing certification bodies ISO 13485, MDR notified bodies and the UK MDR approved body. He is a lead auditor, product specialist and certifier for active medical devices. His expertise spans auditing, regulatory compliance and certification processes, ensuring adherence to ISO 13485 standard as well as European and UK regulations for medical devices.
Agata Stodolna | TÜV Rheinland
PhD, Lead Auditor / Medical Device Specialist
As a Lead Audito Agata is responsible for conducting audits under multiple schemes related to Medical Devices. Additionally, she is responsible for certification decisions for UK schemes as a TUV Rheinland UK Certifier. Her expertise is in In Vitro Diagnostic Devices. Agata has obtained a PhD from University of Birmingham, specialising in molecular and cancer diagnostics. She has worked for a company that manufactured molecular diagnostic tests and accessories, being involved in Design and Development, Manufacturing as well as QA/RA.
Fully booked for this year - event closed.
WE HAVE CLOSED SIGN-UP - EVENT IS FULLY SIGNED UP TO MAXIMUM CAPACITY.
If you would like to join the waitlist to be notified about upcoming events, please contact Grzegorz Dziedzic on Email: Grzegorz.Dziedzic@tuv.com
Bonus opportunity for registered participants
Register now and receive your exclusive 10% discount voucher for your next Medical Device Testing service!
10% discount on testing services for medical electrical and in-vitro diagnostic devices
Register now and receive your exclusive 10% discount voucher for your next Medical Device Testing service!
- Valid for one project only
- Valid until 31 December 2026
- Applicable exclusively to services provided by TÜV Rheinland Poland
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