World Medical Device Summit, Konstanz
May 15th-16th, 2024

The context

The WMDS 2022 and WMDS 2023 identified the shortcomings of regulatory systems and defined the priorities of projects to address these issues. 

Projects with the highest priority have been initiated and first results will be available. Among those are “regulatory intelligence”, “regulation as code” and “real-time validation of conformity”. 

The objectives

The goals of WMDS 2024 are to 

• network all actors in the medical device ecosystem to gain a common understanding and to remove the frictions in the current regulatory system. 

• finetune and update the picture of a perfect (global) regulatory system. 

• assess the project results and provide guidance and support for these projects. 

• learn from other industries how to improve the regulatory systems. 

• identify common and overlapping projects and areas of cooperation between regulatory bodies and other stakeholders. 

• identify the requirements, prerequisites, and general conditions of regulatory bodies (policy makers, authorities, notified bodies) to achieve real-time compliance and enforcement

The agenda

• The World Medical Device Summit 
  About the platform, goals, participants, retrospective, and status quo 

• The regulatory system(s) of the future 
  Alignment of goals and visions 

• Projects and initiatives worldwide 
  Current efforts and learnings, streamlining and harmonization of approaches 

• Regulation as Code 
  The core principles, the impact on regulatory systems, first results, and requirements for the regulator of the future 

• Real-time compliance 
  The core principles, changes for regulators and manufacturers, first results

• Harmonization of regulatory systems 
  Updates by regulatory bodies, commonalities and differences, impact on process automation 

Invited participants for the WMDS 2024

Governments, policy makers, authorities

• EU Commission*
• FDA*
• German Health Ministry*
• National and state ministries*
• ZLG (competent authority)*
• Australian Health Products Regulation Group
• UK MHRA
• SwissMedic
• Ireland HPRA
• France ANSM
• Denmark DKMA
• IMDRF

Notified Bodies

• TÜV SÜD*
• Berlin Cert*

Manufacturers and manufacturer associations

• Medical Mountains *
• Spectaris*
• ROCHE Diagnostics*
• SIEMENS Healthineers*
• Philips Healthcare

Academia / Science

• Harvard MIT Center of Regulatory Science*
• University of Copenhagen*
• TU Dresden*

Healthcare providers

• University of Heidelberg*
• Helios Kliniken*

* Participant of previous summits

The venue

As in previous years the WMDS participants will meet in Konstanz, Germany for two days: May 15th – May 16th.