In her opening address, Baden-Württemberg's Minister of Economic Affairs, Hoffmeister-Kraut, wished the participants of the World Medical Device Summit every success. She emphasized how important the healthcare industry is for the region and how indispensable good regulation is.
Regulatory scientists from the Johner Institute and Harvard University presented the latest research data, which revealed the extent of MDR's impact on medical device approval and that Europe is falling far behind the US in this respect.
In this context, several ministries were dismayed to hear how many companies want to give up because of MDR during further conversations.
Regulation can only be effectively designed based on scientific evidence and a consensus on the goals it intends to achieve. Both are currently lacking. There are also no metrics to determine if the goals are being met and no feedback to which the regulation must respond.
Bakul Patel, the former director of the FDA Center for Digital Health, reported that the FDA systematically invests in research and employs between 200 and 300 regulatory scientists to arrive at good regulation. The EU Commission, in comparison, has between 20 and 30 people working on MDR and IVDR, including not a single regulatory scientist.
The participants found it crucial that, for the first time, all parties sat together and talked to each other. They value the WMDS as a process and neutral platform to contribute to better health care and a competitive standard.
For this purpose, short-term measures were derived, and a list of questions for the regulatory scientists of the Johner Institute and Harvard University was developed. The EU Commission pointed out that the MDR's degrees of freedom could be better used.
All in all, the first World Medical Device Summit gave great hope and was a moving experience for all participants.
Dr. Helmut Scherer from Erbe Medizintechnik wrote:
"I found the meeting with all players (authorities, EU, manufacturers, scientists, and physicians) very good and important to create a common understanding of the situation – especially the preparation and scientific support presents the situation neutrally and fact-based. This reduces the emotional discussion and ideally complements the previous activities mostly based on examples."
In this context, Professor Minssen of the Kopenhagen University hopes that the World Medical Device Summit will continue to be the platform where all stakeholders come together to create better regulation.
The objectives of the WMDS 2023 were:
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 the first results will be available. Among those are “regulatory intelligence,” “regulation as code,” and “real-time validation of conformity.”
Governments, Policymakers, Authorities
Notified Bodies
Manufacturers and Manufacturer Associations
Academia and Science
Healthcare Providers
* Participants of previous WMDS
The objectives of the WMDS 2024 were:
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