Podcast: Current challenges facing the medical device industry in Germany
Dr Christina Ziegenberg, Deputy Director General of the German industry association, BVMed, and JMDR Editorial Advisory Board member talks exclusively to Marija Capek
Listen to Christina answer questions on the following topics:
- Like many other countries, Germany’s medtech industry has been hit hard financially by the coronavirus pandemic, for example because of postponed operations. What is being done to support the industry in this regard?
- Obviously, implementation of the MDR is also causing challenges for industry due to the increased requirements and costs, especially the costs of re-certifying existing products. What pragmatic solutions are being developed to assist manufacturers?
- When the European Commission published its Notice on the application of Sections 2.3 and 3.3 of Annex IX to the MDR and IVDR with regard to Notified Body audits performed in the context of Quality Management System assessment earlier this year, it looked as though one of the big stumbling blocks holding up the issuance of MDR certificates had finally been cleared. However, some Member States – like Germany – have chosen not to allow remote audits. Do you know why this decision was taken, and how is industry coping with the impact of this restriction?
- The Federal Government has drafted an amendment to the Medical Devices Implementation Act – the MDPG – which includes a new requirement that, following a reported adverse event, an analysis of a medical device by the manufacturer can only be carried out if the patient has given a declaration of consent. Such a change would inevitably impact patient safety. What are your thoughts on this?
- Although the focus at the moment is very much on the MDR, implementation of the IVDR isn’t far off. Do you think German IVD manufacturers are on track to meet the necessary requirements or does more need to be done to support the IVD industry?
