What is the webinar about?
This webinar explores the two new MDR Delegated Acts on Well-Established Technologies (WET), explaining their impact on conformity assessment and clinical evidence requirements for eligible medical devices.
Who should attend?
Medical device manufacturers, regulatory affairs professionals, quality professionals, clinical affairs specialists and anyone responsible for MDR compliance and certification strategies.
What will participants gain?
- Understand the changes introduced by the new WET Delegated Acts.
- Learn how the changes affect conformity assessment and clinical evidence requirements.
- Identify whether your devices may benefit from the expanded WET scope.
- Gain practical insights to support your MDR regulatory pathway.
Speakers
Richard
Holborow
Head of Clinical Compliance, BSI
Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.
Tim
Marriott
Technical Team Manager – O&D, BSI
Technical Team Manager within the Orthopaedic and Dental team at BSI, with over eight years of experience supporting the conformity assessment of medical devices. Responsible for UKCA activities and has held a range of technical roles, including Technical Specialist, Scheme Manager, and Clinical Evaluation Specialist. Prior to joining BSI, spent eight years as a Principal Research Engineer at Zimmer Biomet, specialising in orthopaedic medical devices and biomaterials. Holds a Bachelor's degree and a Doctorate in Biomaterials from the University of Nottingham.
