Day Two – November 6, 2024Wednesday, 6 November 2024

• With so many recent regulatory changes in both the US and Europe, how have innovative device manufacturers been affected?

• Is the MDR more stringent on innovative devices?

• Is the US system easier to navigate?

• Available innovative pathways

  • Global timelines, costs and harmonisation

• Looking to the future

  • How can innovation be encouraged by all stakeholders?

  • What is the outlook for the wider public if innovation remains a sub-thought?

• Biggest FDA regulatory changes to keep an eye on

• What's on the priority list for 2025?

• Current certification procedure

  • Timelines, costs, available help

  • Comparison to EU process – can you leverage data or documents for both regions?

• Future of the FDA system

  • Which pain points would industry like to see resolved?

• Current regulatory pathway for the EU MDR and the deadline extensions

• Experience of those who qualified for the extension and who didn’t

• How does the EU MDR compare to UK and Swiss regulations?

• State of medical device market in Europe

  • Have the extensions improved the outlook for Notified Bodies, Industry and the wider public?

• Next steps

  • Most important steps for those continuing with transitions

• Breaking down the final rule

• Differences to documentation and submission procedures

• Timelines for transition

• Impact on regulators and industry

  • What is your company is already 13485 compliant?

  • How will the FDA inspect in the interim?

• Future of harmonisation

There are updated requirements regarding software and cybersecurity. How can you update your software design control process to appropriately categorize software to ensure your outputs meet regulatory requirements?

Since Brexit has been effective, the UK government has implemented its own UK Medical Device Regulation and set of guidance documents. Manufacturers have had to adjust their Regulatory strategy to continue to place their devices on the market, and candidate UK Approved Bodies have had to go through the UK designation process to offer UKCA Certification to manufacturers.

This session is intended to:

• Present the existing paths to place medical devices on the UK market

• Highlight differences between CE marking and UKCA marking

• Discuss the up-coming UK regulation changes (new regulation, international recognition project…)

Learning Objective:

• Understand the Medical Devices UK regulatory landscape

• Identify commonality and differences between EU and UK Medical device Regulations

• Be aware of upcoming changes in the UK MDR

Please contact: Linda Cole – linda.cole@informa.com

Or Call +44 (0)2080520405 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar 

• Latest update on IMDRF

  • Countries involved in the initiative

• Progress report

  • How far is IMDRF towards their 2025 goals?

  • Which priorities are there post-2025?

• The future of the medical device industry

  • How will IMDRF change global harmonization?