On this year’s TÜV SÜD medical device forum taking place in Hamburg´s historic "Kaffeebörse" SSS were invited to share their view in a presentation about the conduct of clinical investigations under the new medical device regulation (MDR). Dr. Max Mösmang, Senior Project Manager at SSS International Clinical Research, pointed out that the regulation which will come into force on 26. May 2020 will demand increased clinical evidence about safety and benefits to be demonstrated by manufacturers of medical devices. He also explained differences in the conduct of clinical investigations between the current practice required by medical device directive (MDD) and the upcoming MDR.
Main topic of the conference has been the difficulties for manufacturers and suppliers of medical devices by the more stringent new regulation which replaces the former MDD. Many of the speakers foresee major difficulties in the transition towards the new MDR. Partly because the practical applicability of many of the articles of the MDR has not been clarified yet and respective details are still under negotiations, and partly because the notification of the conformity assessment bodies can probably not be completed within timelines. Hans-Heiner Junker, Senior International Affairs Manager at TÜV SÜD product service, made clear that they are not allowed to receive applications for the conformity testing before they are officially notified under the new standards of the MDR. The tenor of the conference: Regardless of some open questions, manufacturers should start preparation towards the MDR as soon as possible. As many devices will have to undergo the clinical evaluation process, preparations for clinical investigations should be initiated soon. Other measures for manufacturers comprise the updating of the QA system, adaption of the new labelling requirements given by the UDI system (Unique Device Identification) or the amendment of quality assurance agreements with suppliers.