Tuttlingen – With an export quota of around two-thirds, foreign business is enormously important for German medical technology manufacturers, but access to markets outside the EU is anything but easy: the symposium “International Approval of Medical Devices” on March 23rd and 24th reflects on this current and perspective solutions with top-class speakers, including from the FDA and ZLG.
"We would like to show the means by which current challenges can be overcome, but also what important developments can be expected," says MedicalMountains Managing Director Julia Steckeler, looking back on the two days in the Tuttlingen town hall. The starting point is the presentation by Thorsten Stumpf (Metecon GmbH). He gives an update on what is currently happening in important target markets from a regulatory point of view. The activities of the International Medical Device Regulators Forum (IMDRF) and its work on the "Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents" (nIVD ToC) are then looking ahead. Behind this lies the effort to place documents to be submitted on a uniform, global basis as far as possible. dr Rainer Edelhäuser, Director of the Central Office of the Federal States for Health Protection for Drugs and Medical Devices (ZLG), is working on the project and will present it at the symposium. In view of the currently many different specifications, it is clear that they can no longer be mapped in an analogous way. Prof. Dr. Christian Johner (Johner Institut GmbH) therefore devotes his lecture to the "disruption of regulatory processes through digital transformation" and shows what an approval platform with a high degree of digitization can look like. The FDA is already consistently moving in the right direction. Patrick Axtell is one of their ranks. He introduces the eStar process for digital submissions and examines the extent to which a role model for Europe can be derived from it.
All models have the common goal of reducing the effort involved in international approvals and increasing the efficiency of the processes. The workshops on the second day of the symposium go in the same direction: with experts from Veeva Systems Inc., they will work together on how to set up a global regulatory strategy - and how a global technical dossier can help streamline procedures and answer regulatory questions in a uniform manner.
"When it comes to the economic future of German medical technology, there is no way around the global markets," Julia Steckeler is convinced - and excited to see what answers and insights the symposium will provide. The field of speakers offers the best conditions for first-hand information and informative, sometimes controversial discussions: "The fact that Patrick Axtell, a representative of the FDA, is traveling from the USA, the ZLG through Dr. Rainer Edelhäuser is represented and Prof. Dr. We are very pleased that Christian Johner has accepted. They underline the importance that the topic of 'international approvals' has at all levels." Likewise, the dialogue with and between the participants is not neglected, says Julia Steckeler. Scheduling alone ensures that: the symposium begins on March 23 at 2:30 p.m. and ends on March 24 at 12:30 p.m. "We deliberately chose two days to create as much space as possible for exchange, be it during the breaks or on the networking evening on the first day." So that in the end as many practical impulses as possible can be given to further pave the way into the world.
Further information on the symposium “International Approval of Medical Devices” and the possibility to register can be found at this link . Some of the lectures and workshops are held in English.
