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Medical Devices

Structured Dialogue: Innovative Pathways in Europe and UK: A Legal, Manufacturer’s, and Notified Bodies Perspective

Wednesday, May 8, 2024
15:40 – 16:40 CEST
Location: B 05 + B 06
Learning Level: Intermediate

Description: Once considered an ideal location for innovative medical devices, have new regulatory requirements and practices within Europe stifled innovation?

In post-BREXIT Britain, the MHRA has set itself the goal of bringing innovative technologies to patients sooner through its IDAP programme. This is intended to ensure that the UK will offer the “quickest, simplest, regulatory approval in the world”. Can the UK achieve its intended goals and if it does, what will be the impact in the European Union?

What can be done in the current regulatory framework and what regulatory changes are needed encourage innovation back to the EU? What lessons can be learnt from other geographies?

The EU Commission are currently setting the framework to ensure orphan devices continue to have access to the EU market. What is the interplay between an innovative and orphan medical device?

In this session, a panel of legal and regulatory experts from across Notified Body (BSI), specialist law firms and large industry will attempt to answer these questions and discuss the ways that innovation might get back on track within the region.

Industry will consider how manufacturers can maximise the opportunities as part of an innovative device approval pathway, and consider what are the consequences if innovation continues to be stifled.

Legal discussions will offer perspectives on what can already be done within existing regulatory frameworks, and what will need to change.

Finally, the Notified Body will share their view on how the process might work and their role within it – especially if we see a mix of pre-approval by a Competent Authority with a mandatory post-approval acceptance from a conformity assessment body. The notified body will also provide their considerations in relation to what can be achieved through structured dialogue per MDCG 2022-14 and where certificates under conditions can support innovation.

Learning Objectives:

  • Gain a greater appreciation of the underlying nuances of innovative devices within Europe and be able to relay these ideas back to relevant stakeholders
  • Understand the diverse perspectives from different areas of the industry as to the positives, negatives and challenges associated with innovative device pathways
  • Identify opportunities to take advantage of new pathways to market for innovative MedTech