The content of this topic is dealing with questions around the designation process for the new regulations. The output of the so-called designation process is the designation and subsequently the notification of organisations that applied to become a Notified Body. One major topic is the fact that this designation process is not really a re-designation process, but a designation process as the new regulations will not be an update of the existing directives.
During this presentation the speaker will provide an update of the European designation process in general - including the possible effect on manufacturers. Because it will be impossible that all existing Notified Bodies will be designated before May 2020, this will lead to some precautions necessary on the manufacturer’s side. The possible impact on the scope of designation will also be explained.
As the new regulations have a big impact on all parties involved (competent authorities, manufacturers, European representatives, importers, distributors, and of course of Notified Bodies) it is necessary to understand the individual effect of the implementation of the new rules. E.g. the process of generating clinical data as well as the quality of clinical data will be changed by the new regulations. During this presentation the speaker will provide an overview of the changes.
Hans-Heiner Junker has studied in Hamburg Bio-Engineering and joined in February 1980 TÜV in Hanover in the newly established department of Product Safety. His focus was the testing of medical equipment like infusion pumps, ECG, defibrillators, all kinds of medical devices used in ICU’s after they have been put into operation.
He has witnessed the beginnings of the first German Medical Device Regulation, and collected during the safety checks of medical devices in hospitals and doctors’ offices experiences - also about the handling and use of medical devices in daily clinic environment.
In 1989 he decided to leave the TÜV Hannover to join the newly established TÜV Product Service - later called TÜV SÜD Product Service. In 1999 he became the regional operations manager of the test laboratory in Boulder, Colorado, where he was working until 2002. The events of September 9, 2011 eventually led to a new orientation. Since 2002, he is now working in the certification department for Medical Devices in Munich. From 2008 until 2016 he was the head of this certification department.
Hans-Heiner Junker is also active outside TÜV SÜD. He represents TÜV SÜD as a Notified Body in Germany and abroad. He is the chairman of NB-MED and vice president of the European association of Notified Bodies, called Team NB.
Since 2016 he is focusing on European and International Affairs.