Pre-Conference Workshop: What Does it Take From CE to MDSAP?

Description: 2024 is the 10th anniversary of the MDSAP launch.
As the international standard (ISO 13485) on which this regulatory QMS certification program is based is also an European harmonised standard, the question of the EU participation within MDSAP has been on the table since the first days.
Each of the 5 MDSAP member countries found modalities to integrate the program at their convenience.
Four additional countries are MDSAP affiliate members. UK and Switzerland are considering integrating the program.
Despite of continuing trails of discussions at various levels on this aspect, EU remained in an observer position of the MDSAP progression and spreading.

Are there any insurmountable obstacles to the full EU participation to MDSAP?
Would it be beneficial for economic operators and NBs if EU effectively found a pathway to its MDSAP participation?
Would it be the appropriate way to facilitate the implementation of the requirements of the plethora of global regulations that manufacturers of medical devices must adhere to, including EU?

This workshop shall focus on
• The regulatory aspects of a hypothetical full participation of the EU in the MDSAP program
• The practical aspects of integrating the EU requirements within the MDSAP Audit Approach
• The feedback and perspectives of MD & IVD auditors who have both qualifications (MDR/IVDR & MDSAP)
• The perspectives of MD & IVD manufacturers

The workshop is designed to be as interactive as possible. Ideally at the end of the workshop, based on their pooled experiences, speakers and the participants will have built a table of pros and cons for this interesting regulatory option.

The Preconference workshops are not included in the Main Conference registration. You can register for the workshop via the website: Visit the website!