Fortbildung & SeminarLSN Event 12th Symposium on medical technology

After more than ten years of great success, the 12th Symposium will take place in close collaboration between NSF PROSYSTEM and Life Science Nord.

On March 20, 2023, the EU published the Regulation (EU) 2023/607 of the European Parliament and of the Council amending MDR Regulation 2017/745 as well as IVDR Regulation 2017/746 with new transitional provisions for certain medical devices and IVDs. The extensions are four and a half years for high-risk devices and five and a half years for medium and lower risk devices.

The lack of conformity assessment capacities by Notified Bodies was one of the main drivers for this adjustment. In addition, many manufacturers are not fully prepared to meet the strengthened requirements of the MDR within the remaining timeframe of the old transition periods. This has had the potential to threaten the availability of medical devices on the EU market.

Join us, 6 months after regulation 2023/607 came into force – to evaluate the experiences of how to master the regulatory challenges by experts from the EU Commission, Medtech Europe, BVMed, BfArM, Notified Bodies, Manufacturers, Hospitals and other Stakeholders including the voice of the US FDA to provide practical guidance for sustainable implementations.

Please also join us on the evening of September 14 for our traditional Symposium reception & dinner.

At the 12thMedical Devices Symposium you will learn

• All about new MDR transition periods and how you can benefit from them
• The positions from European Commission, industry and Notified Bodies
• The impact of EU requirements on sustainability, ESG and (robust) supply chains
• The importance of the European Health Data Space (EHDS)
• The outlook to non-EU-regulatory systems for medical devices (such as US FDA)