• Format

    Online
    Webinar

  • Date and Time

    CANCELED for April 9, 2026 due to unforeseen personal reasons affecting the presenter

  • Level

    All

  • Price

    Free

Team NB opinion on MDR / IVDR Update Proposal by European Commission

THIS EVENT WILL BE RESCHEDULED SOON.

This event is a part of our Free Webinar Series.
The European Commission’s proposed updates to the MDR and IVDR include important changes affecting the expectations for clinical evidence. These proposals aim to clarify requirements, improve the availability of clinical and performance data, and address challenges manufacturers face when demonstrating safety and performance under the current framework.

In this free webinar, Richard Holborow (Global Head of Clinical Compliance for BSI Notified Body (NL) & BSI Approved Body (UK) ) will present the Team NB perspective on the Commission’s proposal, with a particular focus on clinical evidence. The session will explore how the proposed updates may influence clinical evaluation, evidence generation, and regulatory expectations for medical device and IVD manufacturers operating under MDR and IVDR.

Meet the Speaker

Richard Holborow

Global Head of Clinical Compliance for BSI Notified Body (NL) & BSI Approved Body (UK) 
BSc (Hons) MSCST RCCP

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU. 

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